Ottawa, Ontario/May 1, 2009 – 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 originally expected.
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 production laboratory.
“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.