SILVER SPRING, Md., Dec. 04, 2015 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB:PMCB), 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 representatives from Chamow & Associates, the San Francisco Bay Area firm contracted to assist PharmaCyte in preparing the Chemistry, Manufacturing and Controls (CMC) section of the Investigational New Drug Application (IND) that will be submitted to the drug regulatory authorities before commencement of PharmaCyte’s pancreatic cancer clinical trial, will visit the Austrianova Cell-in-a-Box® encapsulation facility next week located in Bangkok, Thailand.
The purpose of the visit is to determine whether the facility meets current Good Manufacturing Practices (cGMP) standards and to develop the necessary CMC information that must be included in the IND PharmaCyte will be submitting to the U.S. Food & Drug Administration (FDA). The visit will also identify any additional work that must be accomplished at the facility before submitting the IND. The IND is the seminal document that must be acceptable to the FDA and to drug regulatory authorities in other countries where the clinical trial will be conducted. Its acceptance by such authorities is the final step before PharmaCyte’s clinical trial can begin.
Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte, explained, “The visit by representatives of Chamow & Associates is extremely important for ensuring that the CMC section of the IND for our trial in pancreatic cancer is both complete and correct. By virtue of this visit and contributions from Chamow & Associates to our preparation of the IND, we are confident that this critical section of the IND will be acceptable to the FDA and other drug regulatory authorities.”
The Bangkok-based live-cell encapsulation facility will produce capsules with genetically modified live cells using the Cell-in-a-Box® technology that will be used as a new consolidation therapy for patients with inoperable, non-metastatic pancreatic cancer. The new consolidation therapy forms the basis for PharmaCyte’s upcoming clinical trial involving patients with pancreatic cancer whose tumors no longer respond after 4-6 months of treatment with gemcitabine plus Abraxane®, currently the “gold standard” of treatment for advanced inoperable pancreatic cancer.
One of the therapies frequently used for these patients consists of the combination of the anticancer drug capecitabine and x-radiation, a somewhat ineffective and toxic treatment for pancreatic cancer patients. PharmaCyte’s pancreatic cancer treatment will be compared to this combination therapy as a new consolidation therapy after gemcitabine and Abraxane® in patients whose inoperable tumors no longer respond to the gold standard. Progression-free survival and overall survival will be determined for each of the therapies being compared. In addition, the extent to which the comparative therapies can reduce inoperable tumors to become operable will be determined. The safety of the two treatments will be compared as will their effectiveness in ameliorating the pain that accompanies pancreatic cancer. The overall quality of life of the patients undergoing therapy will also be carefully studied.
About PharmaCyte Biotech PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This unique and patented technology will be used as a platform upon which treatments for several types of cancer and diabetes are being developed. PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells that convert an inactive chemotherapy drug (ifosfamide) into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, ifosfamide is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.
In addition to developing a novel treatment for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent 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.
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 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
