OTTAWA, May 1 /CNW Telbec/ - PharmaGap Inc. (TSX-V: GAP) ("PharmaGap" or
"the Company") today announced that it has shipped its lead cancer drug
compound, PhG-alpha-1, to the National Cancer Institute (the "NCI") in
Bethesda, MD, for testing in the NCI's human cell line cancer screen. This
follows the completion of independent analysis and verification of purity and
composition of the drug compound, required as a prerequisite to NCI testing.
It had been previously announced that this test program would commence in
the first quarter of 2009, however circumstances related to drug production
and independent compound analysis required in advance of NCI testing have
resulted in this slight delay. The actual start date and duration of the
testing is subject to NCI schedules, however it is anticipated that the
testing will be completed during the second quarter of 2009, which is as
Working in conjunction with its Clinical Development Group, the National
Research Council (the "NRC"), and CS Bio, an independent peptide production
company in San Jose, CA, the Company has refined its peptide synthesis and
purification capabilities in order to provide for consistent and reliable
production of high quality drug product for use in testing programs at the
NCI, Ottawa Health Research Institute ("OHRI"), and MD Therapeutics, each of
which has been previously announced.
In a parallel activity, the Company contracted with CS Bio of Menlo Park,
CA to produce its lead drug product PhG-alpha-1. This is a first step in
establishing a third party relationship to produce product in accordance with
Good Manufacturing Practices ("GMP"), a set of rigorous procedural and
documentation processes for quality control as required by the US Food and
Drug Administration (FDA) and other regulatory bodies for production of drug
compound in large scale for use in human testing. CS Bio provides a full range
of peptide production and analysis services in its FDA-inspected peptide
"We are very excited to have shipped our product to the NCI to begin
testing. We are also very pleased to have developed a relationship with CS Bio
as a commercial partner for larger scale drug production going forward" said
Robert McInnis, President and C.E.O. of PharmaGap. "The demonstration of the
capacity to produce a consistently high quality, verifiable drug substance in
the quantities required for human testing is a key consideration of the FDA
and Health Canada in approving drugs for human testing."
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)