PharmaGap forms group for PhG-alpha-1 development
2008-06-06 07:03 MT - News Release
Mr. Robert McInnis reports
PHARMAGAP ESTABLISHES CLINICAL DEVELOPMENT GROUP TO TAKE DRUG TO CLINICAL TRIALS
PharmaGap Inc. has formed a clinical development group to direct and deliver the company's clinical development of its PhG-alpha-1 compound for treatment of cancer. The clinical development group has the mandate to execute the program required to generate the data needed for an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for PhG-alpha-1, for approval for use in humans. These studies, often referred to as IND-enabling studies, build upon the compelling animal study data recently announced. The company is pleased that Dr. David Barnes, Dr. Douglas Cowart and Dr. Gary Schwartz have each agreed to join the PharmaGap clinical development group to take PhG-alpha-1 through the process required to gain approval to commence clinical trials in humans. Others will be named to the group as specific elements of the program require.
Dr. Barnes, a physician and molecular biologist, has worked with industry and government in the clinical development, regulation and safety of biologics since 2001, and has extensive experience with both clinical and preclinical drug development. He is a former clinical evaluator, Biologics and Genetic Therapies Directorate, and former head of the biotechnology products surveillance unit, Marketed Health Products Directorate, Health Canada. Dr. Barnes has served as the company's director of clinical development and regulatory affairs since 2005, and will have overall responsibility for the program, reporting to Robert C. McInnis, president of the company.
Dr. Cowart, PharmD (Medical University of South Carolina), a board certified pharmacologist, has over 25 years experience in clinical trials design and planning, with both FDA and international clinical trials experience in over 50 clinical studies. In his practice, Dr. Cowart has developed a consortium of medical, scientific and regulatory consultants to facilitate the developmental needs of emerging pharmaceutical, biotechnology and medical device companies. These same relationships will be brought to bear in pursuing PharmaGap's clinical development program as required.
Dr. Schwartz, chief, melanoma and sarcoma service for Sloan-Kettering's Department of Medicine's division of solid tumour oncology, has been working with the company since 2006. Dr. Schwartz is a medical oncologist specializing in the identification and development of new targeted drugs for cancer therapy, specifically aimed at understanding the mechanisms underlying the cell cycle and cell death, and the role that proteins, including protein kinases, play in these mechanisms. He is a member and attending physician at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Medical College of Cornell University in New York. He is a current member of the American Society of Clinical Oncology's (ASCO) Cancer Foundation Grants Selection Committee (GSC), a former member of the ASCO Scientific Program and Cancer Education committees, and has served as the American Association of Cancer Researcher's (AACR) co-chairperson for the program committee on translational research in molecular biology. Dr. Schwartz is also an editorial board member of the Journal of Clinical Oncology and an associate editor of Clinical Cancer Research.
Each of Dr. Barnes, Dr. Cowart and Dr. Schwartz has developed an extensive network of drug development professionals and contacts within the medical and pharmaceutical industry with specific expertise in all areas of drug development required to take a drug compound into clinical trials. This extended network will be called on to deliver components of the PharmaGap program as required.
Mr. McInnis, president and chief executive officer of the company, said: "We are pleased to have attracted these highly respected physicians to form the core of our clinical development program to take PhG-alpha-1 toward and into clinical trials. I anticipate the naming of other members bringing both general and specific areas of expertise as the program moves forward in the near future. The creation of this development group is significant in that it provides us with a range of experienced professionals working to take PhG-alpha-1 into the clinic that would otherwise not be available to us on a full-time staffed basis, at a cost to the company that provides maximum value to our shareholders."
The initial work to be undertaken will be directed to standard ADME (absorption, distribution, metabolism and excretion) analyses in order to refine the understanding of PhG-alpha-1's interaction with the human physiology, required for establishment of a therapeutic dose range in humans. This work will be carried out by independent contract research organizations to specifications stipulated by the company's clinical development group working in conjunction with Dr. Jenny Phipps, the company's chief scientific officer.
The program will also include the optimization of the drug formulation aimed at maximizing the effectiveness, safety and ease of administration, development of large-scale manufacturing processes and process controls, and definitive toxicology studies required to gain approval for use in human clinical trials.
During the course of this clinical development program the company will continue to develop its pipeline of future drug compounds, and to generate business development opportunities aimed at securing a development partnership, licensing or similar arrangement for PhG-alpha-1 with an established pharmaceutical or biotech company aimed at bringing both additional financial and drug development depth to the program.
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