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Posted On: 11/30/2015 7:55:56 AM
Good newso n a new hire!
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Cellceutix Retains Former Durata Executive Ronald Trust as Regulatory Affairs Consultant
BEVERLY, MA--(Marketwired - November 30, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, announced today that Ronald Trust, PhD, MBA, has been retained as a consultant to the Company to oversee regulatory affairs pertaining to the planned Brilacidin Phase 3 program for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), among other responsibilities.
Dr. Trust has more than four decades of pharmaceutical research and development experience, including senior positions in R&D at Pfizer, Enzon, Wyeth/Lederle, and most recently, Allergan plc affiliate Durata Therapeutics. He has made significant contributions leading to the FDA approval of 11 drugs and supplements, including five antibacterial agents, most notably the blockbuster ZITHROMAX® (azithromycin) and most recently DALVANCE® (dalbavancin) for ABSSSI. An organic chemist by training, Dr. Trust received his PhD in chemistry from the California Institute of Technology and his MBA in pharmaceutical studies from Fairleigh Dickinson University. Dr. Trust has recently formed a regulatory, quality and medical writing consultation firm, PharmExpertise, LLC, with Cellceutix becoming one of its first clients.
"I like what I see in the Cellceutix pipeline and consider it a great opportunity to work with the Company on the late-stage development of Brilacidin for ABSSSI, and future indications" said Dr. Trust. "Cellceutix has done a tremendous job to date, and I look forward to contributing my expertise on regulatory matters to advance the Company's development of products to treat serious and life-threatening medical conditions. The world is in desperate need of novel drugs to combat the growing antibiotic resistance problem, and Cellceutix' technology may be part of the solution."
"We are fortunate to have the services of someone as experienced and accomplished as Dr. Trust," commented Dr. Daniel Jorgensen, Chief Medical Officer at Cellceutix. "It's very difficult to bring new antibiotics to market, and Dr. Trust has been involved with not one, but five successes, including DALVANCE last year. He will play a significant role in advancing the development of Brilacidin, the first completely novel antibiotic to enter a Phase 3 trial in ABSSSI in more than two decades."
Alerts:
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=c...rch=Search
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
http://us2.campaign-archive1.com/?u=9ed1a6b08...f62ba67fd5
Cellceutix Retains Former Durata Executive Ronald Trust as Regulatory Affairs Consultant
BEVERLY, MA--(Marketwired - November 30, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, announced today that Ronald Trust, PhD, MBA, has been retained as a consultant to the Company to oversee regulatory affairs pertaining to the planned Brilacidin Phase 3 program for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), among other responsibilities. Dr. Trust has more than four decades of pharmaceutical research and development experience, including senior positions in R&D at Pfizer, Enzon, Wyeth/Lederle, and most recently, Allergan plc affiliate Durata Therapeutics. He has made significant contributions leading to the FDA approval of 11 drugs and supplements, including five antibacterial agents, most notably the blockbuster ZITHROMAX® (azithromycin) and most recently DALVANCE® (dalbavancin) for ABSSSI. An organic chemist by training, Dr. Trust received his PhD in chemistry from the California Institute of Technology and his MBA in pharmaceutical studies from Fairleigh Dickinson University. Dr. Trust has recently formed a regulatory, quality and medical writing consultation firm, PharmExpertise, LLC, with Cellceutix becoming one of its first clients.
"I like what I see in the Cellceutix pipeline and consider it a great opportunity to work with the Company on the late-stage development of Brilacidin for ABSSSI, and future indications" said Dr. Trust. "Cellceutix has done a tremendous job to date, and I look forward to contributing my expertise on regulatory matters to advance the Company's development of products to treat serious and life-threatening medical conditions. The world is in desperate need of novel drugs to combat the growing antibiotic resistance problem, and Cellceutix' technology may be part of the solution."
"We are fortunate to have the services of someone as experienced and accomplished as Dr. Trust," commented Dr. Daniel Jorgensen, Chief Medical Officer at Cellceutix. "It's very difficult to bring new antibiotics to market, and Dr. Trust has been involved with not one, but five successes, including DALVANCE last year. He will play a significant role in advancing the development of Brilacidin, the first completely novel antibiotic to enter a Phase 3 trial in ABSSSI in more than two decades."
Alerts:
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=c...rch=Search
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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