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Canada Business News and Press Releases
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(EMAILWIRE.COM, February 13, 2009 ) OTTAWA - PharmaGap Inc. (TSX-V: GAP) ("PharmaGap" or "the Company") today announced that, under the leadership of the Company's Clinical Development Group, the Company's lead drug compound PhG-alpha-1 has been accepted for testing at the National Cancer Institute ("NCI"), an institute of the National Institutes of Health ("NIH"). 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, Maryland. 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 to 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 C.E.O. 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 ("CDG") 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 CDG 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 CDG is comprised of:
- 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, ON)
- Dr. Douglas Cowart, Pharm D. (Medical University of South Carolina), a
board certified pharmacologist, with over 25 years experience in
clinical trials design and planning, with both FDA 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 Tumor
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.
(NYC, NY)
- Russell Blacher, a biochemist with over 25 years of experience in the
peptide chemistry of drug development (San Jose, CA)
- 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, IN)
- Dr. Doug McNair, MD, PhD in Biomedical Engineering, specializes in
biostatistics in pre-clinical 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, ON)
- Dr. Isabella Steffenson, PhD in Cell Biology, specializes in technical
medical writing and drug development program review (Ottawa, ON)
The CDG 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 ("IND") to the FDA 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 ("GMP").
About PharmaGap Inc.
PharmaGap Inc. (TSX-V: GAP), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel therapeutic compounds for the treatment of cancer. PharmaGap's research platform targets cellular signalling pathways controlled by Protein Kinase C (PKC) isoforms. PharmaGap's lead drug compound, PhG-alpha-1, is in preclinical development and targets PKC alpha. The Company's strategy is to out-license drug compounds to larger life sciences companies at the preclinical stage. For more information on PharmaGap please visit the Company's website at www.pharmagap.com.
Note: The TSX-Venture Exchange does not accept responsibility for the adequacy or accuracy of this release. No Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially.
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PharmaGap Inc.
Robert McInnis
613.998.3400
info@pharmagap.com 
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