V.GAP great news!!!!!!!!!
PharmaGap's PhG-alpha-1 to undergo NCI testing
2009-02-12 08:38 ET - News Release
Mr. Robert McInnis reports
PHARMAGAP LEAD DRUG TO BE TESTED AT THE U.S. NATIONAL CANCER INSTITUTE
PharmaGap Inc.'s lead drug compound PhG-alpha-1 has been accepted, under the leadership of the company's clinical development group, for testing at the National Cancer Institute, an institute of the National Institutes of Health. The NIH is the primary U.S. federal agency for conducting and supporting medical research. The NCI's mandate is to conduct and foster cancer research in the United States, and is located in Bethesda, Md. Selection for testing is based on preliminary assessment by NCI and is conducted without cost to PharmaGap.
Testing by the NCI is expected to commence in the first quarter of 2009 in its tumour cell panel consisting of 60 human cancer cell lines, followed by analytical comparison with compounds previously subjected to this screening using its proprietary Compare software technology. The testing against the NCI 60 cell line panel is recognized as a standard and expected assay for compound validation in the pharmaceutical development industry. In addition to providing evidence of efficacy in limiting the growth of tumour cell lines, the assay also provides critical insight into the method of action and potential for commercial development of the drug by comparing it with observations from prior testing against the same panel of 60 human cancer cell lines of other experimental drugs (some of which have now been approved for human use).
Robert McInnis, president and chief executive officer of the company, commented: "We are very excited to initiate testing of PhG-alpha-1 at the National Cancer Institute. While there are no assurances of positive results until testing is completed and fully analyzed, this is an important step for the company's testing program and, if successful, will provide key direction to our clinical development group as they direct the program to take PhG-alpha-1 toward testing in humans."
Since August, 2008, the company has been working closely with its clinical development group in developing a program to generate data and further characterize the company's lead drug compound (PhG-alpha-1) that is required prior to applying for approvals to conduct clinical trials in human subjects. The clinical development group provides PharmaGap with access to a world-class drug development team that will direct the company's lead drug toward clinical trials.
As previously announced, the clinical development group comprises the following people:
Dr. David Barnes, MD, a physician and molecular biologist, who 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 (Ottawa);
Dr. Douglas Cowart, PharmD (Medical University of South Carolina), a board-certified pharmacologist, with over 25 years experience in clinical trials design and planning, with both Food and Drug Administration and international clinical trials experience in over 50 clinical studies (Baltimore, Md.);
Dr. Gary Schwartz, chief, melanoma and sarcoma service, for Memorial Sloan-Kettering's department of medicine's division of solid tumour oncology, specializes 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 (New York);
Russell Blacher, a biochemist with over 25 years of experience in the peptide chemistry of drug development (San Jose, Calif.);
Dr. John Dilberger, DVM, PhD in pathology and toxicology, specializes in application of toxicology, pathology and pharmacology expertise to the safety evaluation of drug compounds (Nashville, Ind.);
Dr. Doug McNair, MD, PhD in biomedical engineering, specializes in biostatistics in preclinical and clinical drug development (Kansas City, Mo.);
Dr. Peter Tomlinson, PhD, MBA, with over 20 years of experience in the pharmaceutical industry in Europe and North America (Toronto);
Dr. Isabella Steffenson, PhD in cell biology, specializes in technical medical writing and drug development program review (Ottawa).
The clinical development group is ultimately responsible for direction and in some cases delivery of all aspects of drug development activities and data generation required for submission of an investigational new drug application to the Food and Drug Administration seeking permission to commence testing in humans, commonly referred to as clinical trials. This activity includes full characterization of drug activity -- how it acts in the body and how the body reacts to it -- determination of method of action, completion of chronic toxicity studies to develop a safety profile, and development of large scale production processes and methods in accordance with established good manufacturing practices.
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