OTTAWA, Feb. 12 /CNW Telbec/ - 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
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.
- 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.
- 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
- 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
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.
For further information: Robert McInnis, President & CEO, (613)