PMCB News 01/09/2017 - 0.12
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PharmaCyte Biotech Announces Pre-IND Meeting Date with FDA
Jan 04, 2017
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Jan. 04, 2017 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB
MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it will be meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) on Tuesday, January 17, 2017. The meeting is to discuss numerous aspects of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commenting on the meeting said, "We are pleased that PharmaCyte will be starting out the New Year with a meeting with CBER. PharmaCyte has submitted a list of important questions to the FDA that will be essential to the design of our trial and how it is to be conducted. The questions also touch on the need for any additional information to be developed or submitted to the FDA before PharmaCyte files its Investigational New Drug application (IND). We are looking forward to CBER’s responses so that we can continue with our product development of an effective and safe therapy for LAPC.”
PharmaCyte recently submitted questions to the FDA as part of its pre-IND submission package. With answers to these questions and any additional information provided by CBER during the January 17 meeting, PharmaCyte will address any open issues or requests of CBER before preparing its IND. Once the IND is submitted and found to be acceptable to the FDA, PharmaCyte can proceed with its planned clinical trial in LAPC and enroll patients at the selected trial sites throughout the U.S.
PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature - with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of ifosfamide to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2017 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech’s Cannabinoid Therapy May Offer Potential for Childhood Brain Cancers
Dec 27, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Dec. 27, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that recent research performed at the Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University’s Feinberg School of Medicine and published in the journal Child’s Nervous System provides further support for PharmaCyte’s efforts to develop a targeted cannabinoid-based chemotherapy for brain cancer utilizing its technology.
The article, titled “Spontaneous involution of pediatric low-grade gliomas: high expression of cannabinoid receptor 1 (CNR1) at the time of diagnosis may indicate involvement of the endocannabinoid system,” showed that activators of the endocannabinoid system offer potential therapeutic opportunities for children with pediatric low-grade gliomas (P-LGG). P-LGGs consist of a mixed group of brain tumors that represent the majority of central nervous system tumors in children. Some P-LGGs exhibit spontaneous shrinking after less than total surgical removal. For the first time, spontaneous shrinking of P-LGG has been suggested to be induced by endocannabinoids.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “It is clear that PharmaCyte is on the right track to developing targeted therapies for deadly cancers. The research reported in the journal Child’s Nervous System, as well as other research, continues to demonstrate the anti-cancer properties of cannabinoids. We remain confident that Cell-in-a-Box® offers a safe and versatile platform for targeted chemotherapy delivery to cancerous tumors in the brain.”
The researchers investigated molecular indicators of spontaneous shrinking in P-LGGs and found that tumors that remained stable or had spontaneous shrinking after surgery had significantly higher levels of expression of the CNR1 gene at the time of diagnosis. They hypothesize that high expression levels of CNR1 make P-LGGs more susceptible to the anticancer effects of normally occurring substances in the body known as endocannabinoids. By extension, plant-derived phytocannabinoid molecules, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), may provide similar effects through their known interaction with endocannabinoid receptors like CNR1.
An abstract of the research may be viewed at: https://www.ncbi.nlm.nih.gov/pubmed/27613640
PharmaCyte’s cannabinoid program at the University of Northern Colorado involves developing a bioengineered cell line that will activate a cannabinoid-based prodrug into its cancer-killing form and then encapsulating these cells using the Cell-in-a-Box® encapsulation technology. When the capsules are implanted near the tumor and the cannabinoid prodrug is administered to a patient, targeted chemotherapy results. Prodrugs of THC and CBD are candidates for this program, and brain cancer is PharmaCyte’s initial target using this cannabinoid therapy.
Mark L. Rabe, MD, a member of PharmaCyte’s Medical and Scientific Advisory Board, commented, “It is fascinating to think the body has built-in anti-cancer capabilities in the form of the endocannabinoid system. Cell-in-a-Box® offers an ideal way to leverage the endocannabinoid system’s power by delivering THC and CBD to brain tumors like P-LGG in a targeted fashion, with the potential benefits of enhanced efficacy and fewer side effects.”
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as an “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Submits Pre-IND Meeting Package to FDA
Dec 15, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Dec. 15, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has submitted its pre-Investigational New Drug (pre-IND) meeting package to the U.S. Food and Drug Administration (FDA) for PharmaCyte’s therapy in inoperable locally advanced pancreatic cancer (LAPC). PharmaCyte’s pre-IND submission follows its recent announcement that the FDA has granted PharmaCyte a pre-IND meeting for its pancreatic cancer therapy.
The package provides the FDA with a full history of PharmaCyte’s therapy, including information on the previous preclinical studies and the clinical trials that were performed using the Cell-in-a-Box® live-cell encapsulation technology combined with low doses of the chemotherapy drug ifosfamide. That combination makes up PharmaCyte’s pancreatic cancer therapy. The package also provides detailed information on the manufacturing process used to produce the Cell-in-a-Box® capsules and a synopsis of the structure of the clinical trial that PharmaCyte plans to conduct in the U.S. and Europe in patients with inoperable LAPC.
The FDA’s response to the pre-IND submission will be provided after the pre-IND meeting. The regulatory agency’s response will serve as a roadmap in guiding PharmaCyte as it prepares the full IND application that must be deemed acceptable to the FDA before the clinical trial can begin.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “The submission of the pre-IND package is yet another major step that PharmaCyte has completed in its efforts to develop its pancreatic cancer therapy. We are looking forward to the pre-IND meeting and the FDA’s guidance as we prepare for our clinical trial in patients with inoperable LAPC where there is an unmet medical need we plan to address.”
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Secures Funding Opportunity for Pancreatic Cancer Clinical Trial
Dec 12, 2016
OTC Disclosure & News Service
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PharmaCyte Biotech Secures Funding Opportunity for Pancreatic Cancer Clinical Trial
NEW YORK, NY--(Marketwired - December 12, 2016) - All of the pieces are starting to fall into place for PharmaCyte Biotech (OTCQB: PMCB) and its upcoming human clinical trial in advanced pancreatic cancer. Just one week after the U.S. Food and Drug Administration (FDA) granted the biotech a pre-IND (Investigational New Drug) meeting to discuss the company's clinical trial, PharmaCyte qualified to use its multi-million dollar "at-the-market" funding arrangement with Chardan Capital in order to enroll every single patient into its upcoming clinical trial.
PharmaCyte's CEO, Kenneth L. Waggoner, commenting on why this funding source is so important to his small biotech said, "We are fortunate that our shareholders saw the value proposition in the company to invest at a level that enables us to once again qualify to use this source of capital. Small biotech companies often run out of money before their products even get a chance to succeed, and this funding opportunity goes a long way in minimizing that possibility.
"We are in the process of finalizing PharmaCyte's ability to use this funding source to help us pay for our upcoming clinical trial and our continued operations. Of course we are always exploring other sources of funding as well, but this opportunity is a very cost effective way to fund the clinical trial. The key is to get the trial underway and validate our therapy for pancreatic cancer.
"Dr. Matthias Löhr recently commented on the technology, the trial design and the team that will be involved with the trial. In my opinion, we couldn't be in better shape at this point. All of the pieces are falling into place quite nicely."
This funding is key to PharmaCyte's success and the key to bringing pancreatic cancer patient's hope. The company's therapy is expected to meet an unmet medical need, and it's hard to imagine any company in the entire bio-pharmaceutical industry that has a more impressive team surrounding its technology and its treatment than PharmaCyte does.
Waggoner has been able to land a team of world-renowned oncologists to surround his company's signature live-cell encapsulation technology, Cell-in-a-Box®, that includes leading pancreatic cancer expert Dr. Daniel Von Hoff from Translational Drug Development (TD2), Dr. Manuel Hidalgo from Harvard Medical School, and Dr. Matthias Löhr from the Karolinska Institute in Stockholm, Sweden.
Waggoner said that the one thing he's constantly thinking about is the infinite possibilities for his company's platform technology Cell-in-a-Box® to treat so many forms of solid tumor cancers -- liver, breast, ovarian -- to name a few.
Waggoner added, "Closely behind the infinite possibilities are the amazing oncologists that are involved with our technology and our clinical trial. In my opinion, we couldn't have put together a stronger team to insure our technology has the best chance for success. I often think of the benefit that so many pancreatic cancer patients, who have little to no hope when they receive no further benefit from the first line standard of care, may get if our therapy performs in the way we believe it will perform. Of course, being in front of the FDA means we are with a drug regulatory agency that leads the world in regulating drug development and therapies to treat diseases. That's pretty awesome."
Waggoner's excitement about getting through a whole host of milestones and now having PharmaCyte's therapy before the FDA is contagious. After all it was this latest milestone -- being granted a pre-IND meeting by the FDA -- that sent his company's stock flying over 590% and giving the company the $75-million unaffiliated market capitalization (now over $100 million) that it needed to qualify for the opportunity it now has to fund its pivotal clinical trial.
"We've come a long way since I took over in January 2014. Now that we're at the FDA, it's extremely satisfying and exciting. But being there is just another new beginning. We are fully committed to seeing this technology validated so that we can be but a small part of a very long journey in changing how solid cancerous tumors will be treated in the future.
"It is very gratifying to be part of developing a therapy for solid cancerous tumors that are treated with chemotherapy that results in no meaningful side effects. Just think of the quality of life of a cancer patient with our therapy verses what a patient has to endure with traditional chemotherapy."
PharmaCyte's CEO knows the FDA's pre-IND process is a vital step to submitting an Investigation New Drug application (IND), and he says his team will be ready for that most important pre-IND meeting in front of the FDA.
"We will be submitting a very lengthy pre-IND package that provides detailed information and data on our therapy and proposed clinical trial. We will be flying key members of our team from Europe to the U.S. to prepare for and participate in the meeting with the FDA. There will be substantial preparation before the meeting with our team of new regulatory experts. They have extensive experience with the FDA in pre-IND and other meetings. We are in good hands."
While PharmaCyte is certainly in good hands with its upcoming clinical trial, the company's shareholders must be feeling they too are in good hands with a CEO that has done everything he said he would do since he came on board. Waggoner said he knows that PharmaCyte is in a marathon -- not a sprint. "In my opinion, the potential of our therapy is grossly undervalued, but one day I believe that our share price and our great story will match."
About Stock Market Media Group
Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles. This article was written based upon publicly available information. Stock Market Media Group was not compensated for the production of this article.
Stock Market Media Group may from time to time include our own opinions about the companies, their business, markets and opportunities in our articles. Any opinions we may offer about any of the companies we write about are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any of the securities we write about are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid, and as a starting point for doing additional independent research. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: www.sec.gov, where you can also find all of PMCB's filings and disclosures. We also recommend, as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.
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Copyright © 2016 Marketwired. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Discusses Upcoming Clinical Trial in Pancreatic Cancer with First Principal Investigator
Dec 07, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Dec. 07, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, released today the first article in a series of Q&A articles that will be conducted with some of the key team members of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte’s first Q&A article is with Dr. Matthias Löhr of the famed Karolinska Institute in Stockholm, Sweden. Dr. Löhr was the Principal Investigator of the two earlier clinical trials using the Cell-in-a-Box® technology in patients with advanced, inoperable pancreatic cancer.
As PharmaCyte prepares to meet with the FDA in a Pre-IND meeting, what are your general thoughts of the Cell-in-a-Box® plus low dose ifosfamide therapy for pancreatic cancer once again getting a chance to prove itself in patients?
Dr. Matthias Löhr: “I feel very confident and also happy to see the revival of this treatment concept. I consider Cell-in-a-Box® as a platform technology. The previously raised concerns relating to the consistent reproducibility of the micro-capsules have been met by Austrianova in the meantime. Pancreatic cancer is a medical emergency (https://www.researchgate.net/publication/265394214_Pancreatic_cancer_should_be_treated_as_a_medical_emergency) and is rising amongst the cancer related deaths, this year surpassing breast cancer to become number three, and by 2030 to become number two.”
As the Principle Investigator of both of the earlier clinical trials, what are some of the highlights you recognized that you feel will once again be seen in PharmaCyte’s upcoming trial?
Dr. Matthias Löhr: “When we treated the first patients, they did not believe that they were receiving chemotherapy because there were NO side effects at all in the initial trial. That should be the case in PharmaCyte’s upcoming trial. Besides this very subjective impression, albeit repeated by all patients, we measured the quality of life, which was excellent - considering the dire disease. We will be measuring the quality of life in the upcoming trial as well. Further, we saw an effect not only on the primary tumor in the pancreas (where the capsules were injected) but also in some patients on the liver metastasis. This can only be explained by an immunological bystander effect that will likely be investigated in more depth in the upcoming clinical trial. Finally, in the first trial, certain patients’ tumors went from inoperable to operable. That is certainly a possibility in PharmaCyte’s trial, especially since we will be giving more than two courses of ifosfamide like we did in the first trial.”
Why do you feel this new trial design can succeed?
Dr. Matthias Löhr: “The locally advanced pancreatic cancers are not sufficiently covered by guidelines - there is no standard of care, hence a highly unmet medical need. This refers particularly to those patients who received first line therapy, e.g. a very strong one (FOLFIRINOX) or combination of gemcitabine with Abraxane®. AFTER this therapy, there is nothing left, especially an alternative with a low likelihood of side effects. The selection of these patients (group) is certainly to an advantage of the Cell-in-a-Box® technology, which is mostly localized, may have a systemic (immunological) effect and has virtually no side effects. We consider this an ideal setting to the advantage of our patients in this upcoming clinical trial.”
What are your thoughts on the benefits of using more rounds of the chemotherapy prodrug ifosfamide as PharmaCyte’s trial design calls for in this upcoming clinical trial?
Dr. Matthias Löhr: “This will definitively improve the outcome of the patients in this upcoming clinical trial. We couldn’t do this in the original trial(s) as we had no information on the stability of the capsules and activity of the cells converting the chemotherapy drug ifosfamide. This has changed now with the data developed from the first two trials. We will continue to administer ifosfamide until the patients receive no further benefit from our therapy. We can do that because we know the capsules are robust for at least two years and that the cells within them continue to convert ifosfamide during the life of the patient.”
What are your thoughts on going head to head with gemcitabine?
Dr. Matthias Löhr: “No sweat. Gemcitabine is still the standard, due to the excellent tolerability of the drug and will be the drug used second line, especially after heavy protocols such as FOLFIRINOX or gemcitabine/ Abraxane®. In this pretreated patient group, one has to use something with a very low profile on side effects. This is certainly the case with our Cell-in-A-Box®.”
What are your impressions of the team that surrounds the technology as PharmaCyte heads into its planned clinical trial?
Dr. Matthias Löhr: “PharmaCyte has the visionary capacity to see the potential of this platform technology, with pancreatic cancer being the first indication. They reached out to the original team, both those developing the technology and conducting the early phase clinical trials. Taking this knowledge on board is certainly the most important factor to ensure success. Further, with both Dr. Manuel Hidalgo and Dr. Daniel Von Hoff, two eminent oncologists with a lifetime track record in oncology and especially pancreatic cancer, the starting conditions could not be better.”
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Granted FDA Pre-IND Meeting for Pancreatic Cancer Therapy
Nov 29, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Nov. 29, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that a Pre-Investigational New Drug (Pre-IND) meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA. During the meeting with representatives from CBER, they will respond to PharmaCyte’s previously submitted questions to the FDA as part of a Pre-IND information package related to PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte will be submitting a full Pre-IND package of information to the FDA that describes what PharmaCyte intends on submitting in its Investigational New Drug (IND) application. The FDA will review PharmaCyte’s manufacturing, preclinical pharmacology and toxicology and clinical trial plans for the company’s therapy to treat LAPC. After the FDA has responded to the questions and issued comments, PharmaCyte will undertake steps to address them to the FDA's satisfaction which will lead directly to the preparation of the IND application itself. Once the IND application is found to be acceptable to the FDA, patients can be enrolled in PharmaCyte’s clinical trial.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented about the Pre-IND meeting saying, "We are pleased that the FDA has granted us a Pre-IND meeting in connection with our planned clinical trial for LAPC patients whose disease has already received maximum response from the gold standard of care - the combination therapy of Abraxane® plus gemcitabine. Our Pre-IND meeting is the next step in getting our pancreatic cancer therapy into a clinical trial and approved by the FDA. We believe PharmaCyte is well on its way to accomplishing this goal.”
PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they may become operable.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Now Awaits U.S. FDA to Advance Pancreatic Cancer Therapy into Pivotal Clinical Trial
Nov 16, 2016
OTC Disclosure & News Service
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PharmaCyte Biotech Now Awaits U.S. FDA to Advance Pancreatic Cancer Therapy into Pivotal Clinical Trial
NEW YORK, NY--(Marketwired - November 16, 2016) - PharmaCyte Biotech (OTCQB: PMCB) has arrived at the door of U.S. FDA and awaits a pre-IND meeting with the agency. After years of surrounding its signature live-cell encapsulation technology, Cell-in-a-Box®, with some of the brightest minds in pancreatic cancer and fine-tuning its therapy and clinical trial design, the small biotech has reached the final test before it can begin its pivotal clinical trial in advanced pancreatic cancer.
PharmaCyte made two recent announcements that would be big for any company, but for a small biotech, the announcements are big news for shareholders who have been patiently waiting. First, it announced that oncologist, Dr. Manuel Hidalgo, who is the Chief of the Division of Hematology-Oncology at Harvard Medical School's Beth Israel Deaconess Medical Center, has accepted the role of Principal Investigator for PharmaCyte's planned clinical trial. And the company followed up that news with the announcement that it has requested a pre-IND meeting with the FDA for its upcoming pancreatic cancer clinical trial.
In PharmaCyte's clinical trial, Dr. Hidalgo will once again be teamed up with renowned pancreatic cancer expert Dr. Daniel Von Hoff. Dr. Von Hoff is the Chief Development Officer at Translational Drug Development (TD2), the nation's premiere oncology CRO and the company responsible for organizing and conducting PharmaCyte's clinical trial.
Dr. Von Hoff and Dr. Hidalgo worked together on the clinical trials that brought the industry what is now the gold standard and the FDA approved treatment for advanced pancreatic cancer, Abraxane® plus gemcitabine.
PharmaCyte has already named a handful of clinical trial sites that are being considered which include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center in Boston, the Dana-Farber Cancer Institute in Boston, the Baylor Cancer Center in Dallas, the City of Hope Cancer Center in Los Angeles and sites in Germany and Spain.
Creating an "Artificial Liver" to Target Pancreatic Cancer
PharmaCyte's pancreatic cancer therapy is made up of pinhead-sized, porous capsules that are filled with thousands of genetically modified cells that act as a type of "artificial liver."
PharmaCyte's Cell-in-a-Box® is not a drug delivery system. There are no drugs encapsulated inside the porous capsules for any of its treatments. Instead, the capsules are filled with about 10,000 live cells that are capable of converting an inactive chemotherapy drug (ifosfamide) into its active cancer-killing form -- just as the enzyme system in a patient's liver would normally do.
Because the chemotherapy drug ifosfamide is a prodrug or an inactive drug, it can travel all over the body and have no effect whatsoever until it is activated in the liver. PharmaCyte's therapy essentially moves the "normal" conversion site of that inactive drug (the patient's liver) closer to the cancerous tumor by using Cell-in-a-Box® capsules and the live cells inside them to do the job of the patient's liver or to act as an "artificial liver."
How Does PharmaCyte Biotech Do It
The encapsulated live cells (Cell-in-a-Box® capsules) are placed as close to the patient's cancerous tumor as possible. Once implanted, ifosfamide, the aforementioned chemotherapy drug that needs to be activated in the body, is given to the patient intravenously at one-third the normal dose. The ifosfamide is then carried by the circulatory system to where the encapsulated cells have been placed.
When the ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells in the Cell-in-a-Box® capsules, the chemotherapy drug is activated into its cancer-killing form right at the site of the cancer. This is "targeted chemotherapy" in the truest sense, and the company's therapy has proven effective and safe to use in past clinical trials.
Chemotherapy with No Side Effects
The obvious question is why move the conversion site of the chemotherapy drug at all. Well, there are actually a number of reasons to move the activation site closer to the tumor. We'll start with the chemotherapy drug itself.
Ifosfamide, when activated, has a very short half-life (time before it decays and no longer offers any effect), so by using the cells inside the Cell-in-a-Box® capsules to activate the drug at the site of the tumor, ifosfamide can immediately be the most effective when it's the most potent before dying off minutes later.
Without a treatment like PharmaCyte's, ifosfamide would be given to the patient intravenously and then activated "normally" in the liver, the activated drug would then affect tissues and organs other than the pancreas, and by the time it reached the pancreas, it undoubtedly would have lost much of its effectiveness. So, to be effective against a pancreatic tumor when the Cell-in-a-Box® capsules are not used, a large dose of the drug has to be administered.
Using ifosfamide in such large doses has proven to be damaging for tissues and organs including the patient's liver, and because the activated drug would come in contact with such other organs and good cells throughout the body on its way to the pancreas, the side effects would be intolerable; in fact, this is known to be the case.
By moving the conversion site as close to the tumor as possible, PharmaCyte is able to give a much smaller dose of the chemotherapy drug (one-third the normal dose), which patient's are able to tolerate, and because of the smaller dose, the treatment can be administered without any side effects from the chemotherapy.
Next Stop FDA Clinical Trial
With a list of oncologists and clinicians that reads like a who's who now in place to lead PharmaCyte's clinical trial, the company is now awaiting a pre-IND meeting with the FDA. After submitting questions to the FDA as part of a pre-IND meeting request where aspects of the content of the Investigational New Drug (IND) application itself (CMC section, clinical trial description, etc.) will be discussed, PharmaCyte is ready to fully engage with the FDA on its way to receiving the final approval it needs to begin its planned clinical trial in pancreatic cancer.
Once PharmaCyte navigates the pre-IND process and files its IND application, then the FDA will have 30 days to make comments, and if no comments are made, then PharmaCyte is effectively "approved" to begin its pivotal clinical trial.
About Stock Market Media Group
Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles. This article was written based upon publicly available information. PharmaCyte Biotech has not endorsed this article, and Stock Market Media Group was not compensated for its production.
Stock Market Media Group may from time to time include our own opinions about the companies, their business, markets and opportunities in our articles. Any opinions we may offer about any of the companies we write about are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any of the securities we write about are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid, and as a starting point for doing additional independent research. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: www.sec.gov, where you can also find all of PMCB's filings and disclosures. We also recommend, as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.
We are not a registered broker, dealer, analyst, or adviser. We hold no investment licenses and may not sell, offer to sell or offer to buy any security. Our publications about any of the companies we write about are not a recommendation to buy or sell a security.
For more information: www.stockmarketmediagroup.com.
Contact:
Stock Market Media Group
info@stockmarketmediagroup.com
Copyright © 2016 Marketwired. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
University of Northern Colorado Presenting PharmaCyte Biotech’s Cannabis Research at the 2017 American Chemical Society National Meeting
Nov 14, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Nov. 14, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that its research partner, the University of Northern Colorado (UNC), has submitted abstracts for the presentation of two scientific papers at the 253rd American Chemical Society (ACS) National Meeting & Exposition in San Francisco, California, April 2-6, 2017.
The ACS National Meeting provides chemistry professionals a forum to meet, share ideas and advance scientific and technical knowledge. The theme of the upcoming meeting is “Advanced Materials, Technologies, Systems & Processes.” PharmaCyte’s Cannabis research at UNC fits the theme perfectly since it revolves around utilization of PharmaCyte’s proprietary Cell-in-a-Box® technology. The papers will be presented by Dr. Richard M. Hyslop, Principal Investigator and Professor of Chemistry and Biochemistry at UNC and his students.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented “We are very pleased with the ongoing progress at UNC. The upcoming ACS meeting provides an ideal venue to present two more scientific papers that have been generated from the work being done by Dr. Hyslop and his team as well as showcase the versatility of Cell-in-a-Box® as an advanced therapeutic platform.”
The first paper is titled “Development of a cannabinoid-based Cell-in-a-Box® therapeutic system targeted toward malignant tumors.” This aspect of the UNC research investigates the feasibility of a patented cell-encapsulation technology in which cells producing enzymes capable of converting an inactive phytocannabinoid prodrug into an active anti-cancer drug are encapsulated in a cellulose-based porous polymer, which can be injected immediately upstream from a tumor. Then, an administered phytocannabinoid prodrug can be activated by the encapsulated cells at the site of the tumor. The paper describes how, using both specific phytocannabinoids and model compounds, a variety of cell lines have been screened for the appropriate enzymatic activity to convert an inactive cannabinoid prodrug into an active drug. Five cell lines have been observed to produce the desired enzyme and are being further assessed with specific phytocannabinoid prodrugs.
The second paper is titled “In vitro anti-neoplastic activity of specific phytocannabinoids of Cannabis sativa.” As part of a more in-depth study to develop a cannabinoid-based targeted treatment of malignant tumors, the in vitro effects of select cannabinoids on several human cancer cell lines have been investigated, including glioblastoma, pancreatic, breast, melanoma, lung and colon. The paper describes how single-cell layer cultures were treated with increasing levels of a purified cannabinoid and details the resultant changes in cancer cell populations. Initial results suggest that this cannabinoid possesses potent anti-proliferative effects against several types of cancer cells. Studies continue to assess this cannabinoid with several cancer cell lines, and it may represent a viable candidate for further therapeutic evaluation.
Dr. Hyslop has been involved in cancer research for four decades and is leading a team of scientists from UNC to develop a “green” approach to treating solid tumors, initially brain cancer. “We are looking forward to sharing some of our results with the scientific community,” commented Dr. Hyslop. “Our team of biochemists, organic chemists, molecular biologists, genetic engineers, undergraduate students, and graduate students continue to work diligently to achieve our goal of developing targeted cannabinoid-based chemotherapy utilizing Cell-in-a-Box®.”
For more information on the meeting visit: https://www.acs.org/content/acs/en/meetings/spring-2017.html.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “plan” and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte’s ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Requests Pre-IND Meeting with FDA for its Pancreatic Cancer Clinical Trial
Nov 01, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Nov. 01, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it has submitted a request for a pre-IND meeting with the U. S. Food and Drug Administration (FDA) for its planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte has submitted questions to the FDA as part of a pre-IND meeting request where aspects of the content of the Investigational New Drug (IND) application itself (CMC section, clinical trial description, etc.) will be discussed. After the FDA has responded to the questions and issued comments, PharmaCyte must address them to the FDA's satisfaction. A review of PharmaCyte’s responses by the FDA will then take place at the formal pre-IND meeting where final agreement between PharmaCyte and the FDA on all aspects discussed will be reached. With this information, the IND will be submitted by PharmaCyte and reviewed by the FDA. Once the IND is found to be acceptable to the FDA, patients can be enrolled in PharmaCyte’s clinical trial.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the meeting request, "We are pleased that PharmaCyte has taken the first step towards regulatory approval in the United States of its therapy for LAPC. When I started to lead this company in January 2014, my first goal was to surround our technology with the best of the best in the biotech sector. I believe we have more than accomplished this goal as we have compiled an internationally renowned team that will lead PharmaCyte into what we expect to be a pivotal human clinical trial. My second goal was to get our therapy to the FDA, and with this pre-IND meeting request, we have accomplished this goal as well. My ultimate goal, of course, was and is to get our pancreatic cancer therapy into clinical trials and approved by the FDA. I feel we are well on our way to accomplishing this goal.”
PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Last updated 01/09/2017 - 0.12
PharmaCyte Biotech Announces Pre-IND Meeting Date with FDA
Jan 04, 2017
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Jan. 04, 2017 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB
MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it will be meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) on Tuesday, January 17, 2017. The meeting is to discuss numerous aspects of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commenting on the meeting said, "We are pleased that PharmaCyte will be starting out the New Year with a meeting with CBER. PharmaCyte has submitted a list of important questions to the FDA that will be essential to the design of our trial and how it is to be conducted. The questions also touch on the need for any additional information to be developed or submitted to the FDA before PharmaCyte files its Investigational New Drug application (IND). We are looking forward to CBER’s responses so that we can continue with our product development of an effective and safe therapy for LAPC.”
PharmaCyte recently submitted questions to the FDA as part of its pre-IND submission package. With answers to these questions and any additional information provided by CBER during the January 17 meeting, PharmaCyte will address any open issues or requests of CBER before preparing its IND. Once the IND is submitted and found to be acceptable to the FDA, PharmaCyte can proceed with its planned clinical trial in LAPC and enroll patients at the selected trial sites throughout the U.S.
PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature - with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of ifosfamide to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2017 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech’s Cannabinoid Therapy May Offer Potential for Childhood Brain Cancers
Dec 27, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Dec. 27, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB
MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that recent research performed at the Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University’s Feinberg School of Medicine and published in the journal Child’s Nervous System provides further support for PharmaCyte’s efforts to develop a targeted cannabinoid-based chemotherapy for brain cancer utilizing its technology. The article, titled “Spontaneous involution of pediatric low-grade gliomas: high expression of cannabinoid receptor 1 (CNR1) at the time of diagnosis may indicate involvement of the endocannabinoid system,” showed that activators of the endocannabinoid system offer potential therapeutic opportunities for children with pediatric low-grade gliomas (P-LGG). P-LGGs consist of a mixed group of brain tumors that represent the majority of central nervous system tumors in children. Some P-LGGs exhibit spontaneous shrinking after less than total surgical removal. For the first time, spontaneous shrinking of P-LGG has been suggested to be induced by endocannabinoids.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “It is clear that PharmaCyte is on the right track to developing targeted therapies for deadly cancers. The research reported in the journal Child’s Nervous System, as well as other research, continues to demonstrate the anti-cancer properties of cannabinoids. We remain confident that Cell-in-a-Box® offers a safe and versatile platform for targeted chemotherapy delivery to cancerous tumors in the brain.”
The researchers investigated molecular indicators of spontaneous shrinking in P-LGGs and found that tumors that remained stable or had spontaneous shrinking after surgery had significantly higher levels of expression of the CNR1 gene at the time of diagnosis. They hypothesize that high expression levels of CNR1 make P-LGGs more susceptible to the anticancer effects of normally occurring substances in the body known as endocannabinoids. By extension, plant-derived phytocannabinoid molecules, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), may provide similar effects through their known interaction with endocannabinoid receptors like CNR1.
An abstract of the research may be viewed at: https://www.ncbi.nlm.nih.gov/pubmed/27613640
PharmaCyte’s cannabinoid program at the University of Northern Colorado involves developing a bioengineered cell line that will activate a cannabinoid-based prodrug into its cancer-killing form and then encapsulating these cells using the Cell-in-a-Box® encapsulation technology. When the capsules are implanted near the tumor and the cannabinoid prodrug is administered to a patient, targeted chemotherapy results. Prodrugs of THC and CBD are candidates for this program, and brain cancer is PharmaCyte’s initial target using this cannabinoid therapy.
Mark L. Rabe, MD, a member of PharmaCyte’s Medical and Scientific Advisory Board, commented, “It is fascinating to think the body has built-in anti-cancer capabilities in the form of the endocannabinoid system. Cell-in-a-Box® offers an ideal way to leverage the endocannabinoid system’s power by delivering THC and CBD to brain tumors like P-LGG in a targeted fashion, with the potential benefits of enhanced efficacy and fewer side effects.”
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as an “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Submits Pre-IND Meeting Package to FDA
Dec 15, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Dec. 15, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB
MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has submitted its pre-Investigational New Drug (pre-IND) meeting package to the U.S. Food and Drug Administration (FDA) for PharmaCyte’s therapy in inoperable locally advanced pancreatic cancer (LAPC). PharmaCyte’s pre-IND submission follows its recent announcement that the FDA has granted PharmaCyte a pre-IND meeting for its pancreatic cancer therapy. The package provides the FDA with a full history of PharmaCyte’s therapy, including information on the previous preclinical studies and the clinical trials that were performed using the Cell-in-a-Box® live-cell encapsulation technology combined with low doses of the chemotherapy drug ifosfamide. That combination makes up PharmaCyte’s pancreatic cancer therapy. The package also provides detailed information on the manufacturing process used to produce the Cell-in-a-Box® capsules and a synopsis of the structure of the clinical trial that PharmaCyte plans to conduct in the U.S. and Europe in patients with inoperable LAPC.
The FDA’s response to the pre-IND submission will be provided after the pre-IND meeting. The regulatory agency’s response will serve as a roadmap in guiding PharmaCyte as it prepares the full IND application that must be deemed acceptable to the FDA before the clinical trial can begin.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “The submission of the pre-IND package is yet another major step that PharmaCyte has completed in its efforts to develop its pancreatic cancer therapy. We are looking forward to the pre-IND meeting and the FDA’s guidance as we prepare for our clinical trial in patients with inoperable LAPC where there is an unmet medical need we plan to address.”
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Secures Funding Opportunity for Pancreatic Cancer Clinical Trial
Dec 12, 2016
OTC Disclosure & News Service
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PharmaCyte Biotech Secures Funding Opportunity for Pancreatic Cancer Clinical Trial
NEW YORK, NY--(Marketwired - December 12, 2016) - All of the pieces are starting to fall into place for PharmaCyte Biotech (OTCQB: PMCB) and its upcoming human clinical trial in advanced pancreatic cancer. Just one week after the U.S. Food and Drug Administration (FDA) granted the biotech a pre-IND (Investigational New Drug) meeting to discuss the company's clinical trial, PharmaCyte qualified to use its multi-million dollar "at-the-market" funding arrangement with Chardan Capital in order to enroll every single patient into its upcoming clinical trial.
PharmaCyte's CEO, Kenneth L. Waggoner, commenting on why this funding source is so important to his small biotech said, "We are fortunate that our shareholders saw the value proposition in the company to invest at a level that enables us to once again qualify to use this source of capital. Small biotech companies often run out of money before their products even get a chance to succeed, and this funding opportunity goes a long way in minimizing that possibility.
"We are in the process of finalizing PharmaCyte's ability to use this funding source to help us pay for our upcoming clinical trial and our continued operations. Of course we are always exploring other sources of funding as well, but this opportunity is a very cost effective way to fund the clinical trial. The key is to get the trial underway and validate our therapy for pancreatic cancer.
"Dr. Matthias Löhr recently commented on the technology, the trial design and the team that will be involved with the trial. In my opinion, we couldn't be in better shape at this point. All of the pieces are falling into place quite nicely."
This funding is key to PharmaCyte's success and the key to bringing pancreatic cancer patient's hope. The company's therapy is expected to meet an unmet medical need, and it's hard to imagine any company in the entire bio-pharmaceutical industry that has a more impressive team surrounding its technology and its treatment than PharmaCyte does.
Waggoner has been able to land a team of world-renowned oncologists to surround his company's signature live-cell encapsulation technology, Cell-in-a-Box®, that includes leading pancreatic cancer expert Dr. Daniel Von Hoff from Translational Drug Development (TD2), Dr. Manuel Hidalgo from Harvard Medical School, and Dr. Matthias Löhr from the Karolinska Institute in Stockholm, Sweden.
Waggoner said that the one thing he's constantly thinking about is the infinite possibilities for his company's platform technology Cell-in-a-Box® to treat so many forms of solid tumor cancers -- liver, breast, ovarian -- to name a few.
Waggoner added, "Closely behind the infinite possibilities are the amazing oncologists that are involved with our technology and our clinical trial. In my opinion, we couldn't have put together a stronger team to insure our technology has the best chance for success. I often think of the benefit that so many pancreatic cancer patients, who have little to no hope when they receive no further benefit from the first line standard of care, may get if our therapy performs in the way we believe it will perform. Of course, being in front of the FDA means we are with a drug regulatory agency that leads the world in regulating drug development and therapies to treat diseases. That's pretty awesome."
Waggoner's excitement about getting through a whole host of milestones and now having PharmaCyte's therapy before the FDA is contagious. After all it was this latest milestone -- being granted a pre-IND meeting by the FDA -- that sent his company's stock flying over 590% and giving the company the $75-million unaffiliated market capitalization (now over $100 million) that it needed to qualify for the opportunity it now has to fund its pivotal clinical trial.
"We've come a long way since I took over in January 2014. Now that we're at the FDA, it's extremely satisfying and exciting. But being there is just another new beginning. We are fully committed to seeing this technology validated so that we can be but a small part of a very long journey in changing how solid cancerous tumors will be treated in the future.
"It is very gratifying to be part of developing a therapy for solid cancerous tumors that are treated with chemotherapy that results in no meaningful side effects. Just think of the quality of life of a cancer patient with our therapy verses what a patient has to endure with traditional chemotherapy."
PharmaCyte's CEO knows the FDA's pre-IND process is a vital step to submitting an Investigation New Drug application (IND), and he says his team will be ready for that most important pre-IND meeting in front of the FDA.
"We will be submitting a very lengthy pre-IND package that provides detailed information and data on our therapy and proposed clinical trial. We will be flying key members of our team from Europe to the U.S. to prepare for and participate in the meeting with the FDA. There will be substantial preparation before the meeting with our team of new regulatory experts. They have extensive experience with the FDA in pre-IND and other meetings. We are in good hands."
While PharmaCyte is certainly in good hands with its upcoming clinical trial, the company's shareholders must be feeling they too are in good hands with a CEO that has done everything he said he would do since he came on board. Waggoner said he knows that PharmaCyte is in a marathon -- not a sprint. "In my opinion, the potential of our therapy is grossly undervalued, but one day I believe that our share price and our great story will match."
About Stock Market Media Group
Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles. This article was written based upon publicly available information. Stock Market Media Group was not compensated for the production of this article.
Stock Market Media Group may from time to time include our own opinions about the companies, their business, markets and opportunities in our articles. Any opinions we may offer about any of the companies we write about are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any of the securities we write about are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid, and as a starting point for doing additional independent research. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: www.sec.gov, where you can also find all of PMCB's filings and disclosures. We also recommend, as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.
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Copyright © 2016 Marketwired. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Discusses Upcoming Clinical Trial in Pancreatic Cancer with First Principal Investigator
Dec 07, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Dec. 07, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB
MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, released today the first article in a series of Q&A articles that will be conducted with some of the key team members of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte’s first Q&A article is with Dr. Matthias Löhr of the famed Karolinska Institute in Stockholm, Sweden. Dr. Löhr was the Principal Investigator of the two earlier clinical trials using the Cell-in-a-Box® technology in patients with advanced, inoperable pancreatic cancer. As PharmaCyte prepares to meet with the FDA in a Pre-IND meeting, what are your general thoughts of the Cell-in-a-Box® plus low dose ifosfamide therapy for pancreatic cancer once again getting a chance to prove itself in patients?
Dr. Matthias Löhr: “I feel very confident and also happy to see the revival of this treatment concept. I consider Cell-in-a-Box® as a platform technology. The previously raised concerns relating to the consistent reproducibility of the micro-capsules have been met by Austrianova in the meantime. Pancreatic cancer is a medical emergency (https://www.researchgate.net/publication/265394214_Pancreatic_cancer_should_be_treated_as_a_medical_emergency) and is rising amongst the cancer related deaths, this year surpassing breast cancer to become number three, and by 2030 to become number two.”
As the Principle Investigator of both of the earlier clinical trials, what are some of the highlights you recognized that you feel will once again be seen in PharmaCyte’s upcoming trial?
Dr. Matthias Löhr: “When we treated the first patients, they did not believe that they were receiving chemotherapy because there were NO side effects at all in the initial trial. That should be the case in PharmaCyte’s upcoming trial. Besides this very subjective impression, albeit repeated by all patients, we measured the quality of life, which was excellent - considering the dire disease. We will be measuring the quality of life in the upcoming trial as well. Further, we saw an effect not only on the primary tumor in the pancreas (where the capsules were injected) but also in some patients on the liver metastasis. This can only be explained by an immunological bystander effect that will likely be investigated in more depth in the upcoming clinical trial. Finally, in the first trial, certain patients’ tumors went from inoperable to operable. That is certainly a possibility in PharmaCyte’s trial, especially since we will be giving more than two courses of ifosfamide like we did in the first trial.”
Why do you feel this new trial design can succeed?
Dr. Matthias Löhr: “The locally advanced pancreatic cancers are not sufficiently covered by guidelines - there is no standard of care, hence a highly unmet medical need. This refers particularly to those patients who received first line therapy, e.g. a very strong one (FOLFIRINOX) or combination of gemcitabine with Abraxane®. AFTER this therapy, there is nothing left, especially an alternative with a low likelihood of side effects. The selection of these patients (group) is certainly to an advantage of the Cell-in-a-Box® technology, which is mostly localized, may have a systemic (immunological) effect and has virtually no side effects. We consider this an ideal setting to the advantage of our patients in this upcoming clinical trial.”
What are your thoughts on the benefits of using more rounds of the chemotherapy prodrug ifosfamide as PharmaCyte’s trial design calls for in this upcoming clinical trial?
Dr. Matthias Löhr: “This will definitively improve the outcome of the patients in this upcoming clinical trial. We couldn’t do this in the original trial(s) as we had no information on the stability of the capsules and activity of the cells converting the chemotherapy drug ifosfamide. This has changed now with the data developed from the first two trials. We will continue to administer ifosfamide until the patients receive no further benefit from our therapy. We can do that because we know the capsules are robust for at least two years and that the cells within them continue to convert ifosfamide during the life of the patient.”
What are your thoughts on going head to head with gemcitabine?
Dr. Matthias Löhr: “No sweat. Gemcitabine is still the standard, due to the excellent tolerability of the drug and will be the drug used second line, especially after heavy protocols such as FOLFIRINOX or gemcitabine/ Abraxane®. In this pretreated patient group, one has to use something with a very low profile on side effects. This is certainly the case with our Cell-in-A-Box®.”
What are your impressions of the team that surrounds the technology as PharmaCyte heads into its planned clinical trial?
Dr. Matthias Löhr: “PharmaCyte has the visionary capacity to see the potential of this platform technology, with pancreatic cancer being the first indication. They reached out to the original team, both those developing the technology and conducting the early phase clinical trials. Taking this knowledge on board is certainly the most important factor to ensure success. Further, with both Dr. Manuel Hidalgo and Dr. Daniel Von Hoff, two eminent oncologists with a lifetime track record in oncology and especially pancreatic cancer, the starting conditions could not be better.”
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Granted FDA Pre-IND Meeting for Pancreatic Cancer Therapy
Nov 29, 2016
OTC Disclosure & News Service
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LAGUNA HILLS, Calif., Nov. 29, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB
MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that a Pre-Investigational New Drug (Pre-IND) meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA. During the meeting with representatives from CBER, they will respond to PharmaCyte’s previously submitted questions to the FDA as part of a Pre-IND information package related to PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte will be submitting a full Pre-IND package of information to the FDA that describes what PharmaCyte intends on submitting in its Investigational New Drug (IND) application. The FDA will review PharmaCyte’s manufacturing, preclinical pharmacology and toxicology and clinical trial plans for the company’s therapy to treat LAPC. After the FDA has responded to the questions and issued comments, PharmaCyte will undertake steps to address them to the FDA's satisfaction which will lead directly to the preparation of the IND application itself. Once the IND application is found to be acceptable to the FDA, patients can be enrolled in PharmaCyte’s clinical trial.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented about the Pre-IND meeting saying, "We are pleased that the FDA has granted us a Pre-IND meeting in connection with our planned clinical trial for LAPC patients whose disease has already received maximum response from the gold standard of care - the combination therapy of Abraxane® plus gemcitabine. Our Pre-IND meeting is the next step in getting our pancreatic cancer therapy into a clinical trial and approved by the FDA. We believe PharmaCyte is well on its way to accomplishing this goal.”
PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they may become operable.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Now Awaits U.S. FDA to Advance Pancreatic Cancer Therapy into Pivotal Clinical Trial
Nov 16, 2016
OTC Disclosure & News Service
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PharmaCyte Biotech Now Awaits U.S. FDA to Advance Pancreatic Cancer Therapy into Pivotal Clinical Trial
NEW YORK, NY--(Marketwired - November 16, 2016) - PharmaCyte Biotech (OTCQB: PMCB) has arrived at the door of U.S. FDA and awaits a pre-IND meeting with the agency. After years of surrounding its signature live-cell encapsulation technology, Cell-in-a-Box®, with some of the brightest minds in pancreatic cancer and fine-tuning its therapy and clinical trial design, the small biotech has reached the final test before it can begin its pivotal clinical trial in advanced pancreatic cancer.
PharmaCyte made two recent announcements that would be big for any company, but for a small biotech, the announcements are big news for shareholders who have been patiently waiting. First, it announced that oncologist, Dr. Manuel Hidalgo, who is the Chief of the Division of Hematology-Oncology at Harvard Medical School's Beth Israel Deaconess Medical Center, has accepted the role of Principal Investigator for PharmaCyte's planned clinical trial. And the company followed up that news with the announcement that it has requested a pre-IND meeting with the FDA for its upcoming pancreatic cancer clinical trial.
In PharmaCyte's clinical trial, Dr. Hidalgo will once again be teamed up with renowned pancreatic cancer expert Dr. Daniel Von Hoff. Dr. Von Hoff is the Chief Development Officer at Translational Drug Development (TD2), the nation's premiere oncology CRO and the company responsible for organizing and conducting PharmaCyte's clinical trial.
Dr. Von Hoff and Dr. Hidalgo worked together on the clinical trials that brought the industry what is now the gold standard and the FDA approved treatment for advanced pancreatic cancer, Abraxane® plus gemcitabine.
PharmaCyte has already named a handful of clinical trial sites that are being considered which include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center in Boston, the Dana-Farber Cancer Institute in Boston, the Baylor Cancer Center in Dallas, the City of Hope Cancer Center in Los Angeles and sites in Germany and Spain.
Creating an "Artificial Liver" to Target Pancreatic Cancer
PharmaCyte's pancreatic cancer therapy is made up of pinhead-sized, porous capsules that are filled with thousands of genetically modified cells that act as a type of "artificial liver."
PharmaCyte's Cell-in-a-Box® is not a drug delivery system. There are no drugs encapsulated inside the porous capsules for any of its treatments. Instead, the capsules are filled with about 10,000 live cells that are capable of converting an inactive chemotherapy drug (ifosfamide) into its active cancer-killing form -- just as the enzyme system in a patient's liver would normally do.
Because the chemotherapy drug ifosfamide is a prodrug or an inactive drug, it can travel all over the body and have no effect whatsoever until it is activated in the liver. PharmaCyte's therapy essentially moves the "normal" conversion site of that inactive drug (the patient's liver) closer to the cancerous tumor by using Cell-in-a-Box® capsules and the live cells inside them to do the job of the patient's liver or to act as an "artificial liver."
How Does PharmaCyte Biotech Do It
The encapsulated live cells (Cell-in-a-Box® capsules) are placed as close to the patient's cancerous tumor as possible. Once implanted, ifosfamide, the aforementioned chemotherapy drug that needs to be activated in the body, is given to the patient intravenously at one-third the normal dose. The ifosfamide is then carried by the circulatory system to where the encapsulated cells have been placed.
When the ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells in the Cell-in-a-Box® capsules, the chemotherapy drug is activated into its cancer-killing form right at the site of the cancer. This is "targeted chemotherapy" in the truest sense, and the company's therapy has proven effective and safe to use in past clinical trials.
Chemotherapy with No Side Effects
The obvious question is why move the conversion site of the chemotherapy drug at all. Well, there are actually a number of reasons to move the activation site closer to the tumor. We'll start with the chemotherapy drug itself.
Ifosfamide, when activated, has a very short half-life (time before it decays and no longer offers any effect), so by using the cells inside the Cell-in-a-Box® capsules to activate the drug at the site of the tumor, ifosfamide can immediately be the most effective when it's the most potent before dying off minutes later.
Without a treatment like PharmaCyte's, ifosfamide would be given to the patient intravenously and then activated "normally" in the liver, the activated drug would then affect tissues and organs other than the pancreas, and by the time it reached the pancreas, it undoubtedly would have lost much of its effectiveness. So, to be effective against a pancreatic tumor when the Cell-in-a-Box® capsules are not used, a large dose of the drug has to be administered.
Using ifosfamide in such large doses has proven to be damaging for tissues and organs including the patient's liver, and because the activated drug would come in contact with such other organs and good cells throughout the body on its way to the pancreas, the side effects would be intolerable; in fact, this is known to be the case.
By moving the conversion site as close to the tumor as possible, PharmaCyte is able to give a much smaller dose of the chemotherapy drug (one-third the normal dose), which patient's are able to tolerate, and because of the smaller dose, the treatment can be administered without any side effects from the chemotherapy.
Next Stop FDA Clinical Trial
With a list of oncologists and clinicians that reads like a who's who now in place to lead PharmaCyte's clinical trial, the company is now awaiting a pre-IND meeting with the FDA. After submitting questions to the FDA as part of a pre-IND meeting request where aspects of the content of the Investigational New Drug (IND) application itself (CMC section, clinical trial description, etc.) will be discussed, PharmaCyte is ready to fully engage with the FDA on its way to receiving the final approval it needs to begin its planned clinical trial in pancreatic cancer.
Once PharmaCyte navigates the pre-IND process and files its IND application, then the FDA will have 30 days to make comments, and if no comments are made, then PharmaCyte is effectively "approved" to begin its pivotal clinical trial.
About Stock Market Media Group
Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles. This article was written based upon publicly available information. PharmaCyte Biotech has not endorsed this article, and Stock Market Media Group was not compensated for its production.
Stock Market Media Group may from time to time include our own opinions about the companies, their business, markets and opportunities in our articles. Any opinions we may offer about any of the companies we write about are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any of the securities we write about are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid, and as a starting point for doing additional independent research. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: www.sec.gov, where you can also find all of PMCB's filings and disclosures. We also recommend, as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.
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Copyright © 2016 Marketwired. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
University of Northern Colorado Presenting PharmaCyte Biotech’s Cannabis Research at the 2017 American Chemical Society National Meeting
Nov 14, 2016
OTC Disclosure & News Service
-
LAGUNA HILLS, Calif., Nov. 14, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB
MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that its research partner, the University of Northern Colorado (UNC), has submitted abstracts for the presentation of two scientific papers at the 253rd American Chemical Society (ACS) National Meeting & Exposition in San Francisco, California, April 2-6, 2017. The ACS National Meeting provides chemistry professionals a forum to meet, share ideas and advance scientific and technical knowledge. The theme of the upcoming meeting is “Advanced Materials, Technologies, Systems & Processes.” PharmaCyte’s Cannabis research at UNC fits the theme perfectly since it revolves around utilization of PharmaCyte’s proprietary Cell-in-a-Box® technology. The papers will be presented by Dr. Richard M. Hyslop, Principal Investigator and Professor of Chemistry and Biochemistry at UNC and his students.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented “We are very pleased with the ongoing progress at UNC. The upcoming ACS meeting provides an ideal venue to present two more scientific papers that have been generated from the work being done by Dr. Hyslop and his team as well as showcase the versatility of Cell-in-a-Box® as an advanced therapeutic platform.”
The first paper is titled “Development of a cannabinoid-based Cell-in-a-Box® therapeutic system targeted toward malignant tumors.” This aspect of the UNC research investigates the feasibility of a patented cell-encapsulation technology in which cells producing enzymes capable of converting an inactive phytocannabinoid prodrug into an active anti-cancer drug are encapsulated in a cellulose-based porous polymer, which can be injected immediately upstream from a tumor. Then, an administered phytocannabinoid prodrug can be activated by the encapsulated cells at the site of the tumor. The paper describes how, using both specific phytocannabinoids and model compounds, a variety of cell lines have been screened for the appropriate enzymatic activity to convert an inactive cannabinoid prodrug into an active drug. Five cell lines have been observed to produce the desired enzyme and are being further assessed with specific phytocannabinoid prodrugs.
The second paper is titled “In vitro anti-neoplastic activity of specific phytocannabinoids of Cannabis sativa.” As part of a more in-depth study to develop a cannabinoid-based targeted treatment of malignant tumors, the in vitro effects of select cannabinoids on several human cancer cell lines have been investigated, including glioblastoma, pancreatic, breast, melanoma, lung and colon. The paper describes how single-cell layer cultures were treated with increasing levels of a purified cannabinoid and details the resultant changes in cancer cell populations. Initial results suggest that this cannabinoid possesses potent anti-proliferative effects against several types of cancer cells. Studies continue to assess this cannabinoid with several cancer cell lines, and it may represent a viable candidate for further therapeutic evaluation.
Dr. Hyslop has been involved in cancer research for four decades and is leading a team of scientists from UNC to develop a “green” approach to treating solid tumors, initially brain cancer. “We are looking forward to sharing some of our results with the scientific community,” commented Dr. Hyslop. “Our team of biochemists, organic chemists, molecular biologists, genetic engineers, undergraduate students, and graduate students continue to work diligently to achieve our goal of developing targeted cannabinoid-based chemotherapy utilizing Cell-in-a-Box®.”
For more information on the meeting visit: https://www.acs.org/content/acs/en/meetings/spring-2017.html.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “plan” and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte’s ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
PharmaCyte Biotech Requests Pre-IND Meeting with FDA for its Pancreatic Cancer Clinical Trial
Nov 01, 2016
OTC Disclosure & News Service
-
LAGUNA HILLS, Calif., Nov. 01, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB
MCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it has submitted a request for a pre-IND meeting with the U. S. Food and Drug Administration (FDA) for its planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte has submitted questions to the FDA as part of a pre-IND meeting request where aspects of the content of the Investigational New Drug (IND) application itself (CMC section, clinical trial description, etc.) will be discussed. After the FDA has responded to the questions and issued comments, PharmaCyte must address them to the FDA's satisfaction. A review of PharmaCyte’s responses by the FDA will then take place at the formal pre-IND meeting where final agreement between PharmaCyte and the FDA on all aspects discussed will be reached. With this information, the IND will be submitted by PharmaCyte and reviewed by the FDA. Once the IND is found to be acceptable to the FDA, patients can be enrolled in PharmaCyte’s clinical trial.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the meeting request, "We are pleased that PharmaCyte has taken the first step towards regulatory approval in the United States of its therapy for LAPC. When I started to lead this company in January 2014, my first goal was to surround our technology with the best of the best in the biotech sector. I believe we have more than accomplished this goal as we have compiled an internationally renowned team that will lead PharmaCyte into what we expect to be a pivotal human clinical trial. My second goal was to get our therapy to the FDA, and with this pre-IND meeting request, we have accomplished this goal as well. My ultimate goal, of course, was and is to get our pancreatic cancer therapy into clinical trials and approved by the FDA. I feel we are well on our way to accomplishing this goal.”
PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Copyright © 2016 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
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