OTTAWA, June 6 /CNW Telbec/ - PharmaGap Inc. (TSX-V: GAP) ("PharmaGap" or
"the Company") today announced the formation of 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. David G. 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. Douglas Cowart, Pharm D. (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. Gary Schwartz, Chief, Melanoma and Sarcoma Service for
Sloan-Kettering's Department of Medicine's division of Solid Tumor 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 have 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.
Robert C. McInnis, President and C.E.O. 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
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
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.
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:
For further information: Robert McInnis, President & CEO, (613)