Ottawa, Ontario/February 1, 2010 – PharmaGap Inc. (TSX-V: GAP; OTC.BB: PHRGF)
(“PharmaGap” or “the Company”) is pleased to provide an update on testing of its lead cancer
drug GAP-107B8 ongoing at the United States National Cancer Institute (“NCI”) and the program
underway to meet regulatory filing requirements for first clinical trials in the United States and
Canada.
At a meeting between the NCI and PharmaGap in December 2009 to review both the single dose
and five dose results generated in the NCI 60 tumor cell panel screen, it was agreed by the NCI
that further testing of GAP-107B8 at the NCI was warranted in order to further identify additional
selectivity within the 60 cancer cell lines and 7 cancer types and to generate additional dose
response data for GAP-107B8. The NCI has agreed to run its five dose study on GAP-107B8
using a range of doses specifically selected to elicit additional data demonstrating the efficacy,
dose range, and selectivity of GAP-107B8’s on the wide range of cancer types represented in the
NCI screen. Results are anticipated during the first half of 2010.
As earlier reported, at a dose concentration of 100 micromolar (µM), GAP-107B8 caused 100%
growth inhibition (measured against cancer cell growth in untreated groups) in 51 of 56 cancer
cell lines and caused at least 50% cancer cell death (measured against the number of cancer
cells at the beginning of the test period) in 29 of 56 cancer cell lines.
The NCI has also agreed that it will continue to work with PharmaGap in order to identify areas
where the NCI can assist PharmaGap in its development of GAP-107B8.
In addition, the Company has underway a range of testing activities designed to further
characterize the action of GAP-107B8, including pharmacokinetics; drug distribution; the effect on
cell signalling pathways in different cancers and in comparison with existing cancer drugs;
cardiotoxicity; toxicity in rats using intravenous infusion pumps; and development of large volume,
stable, and consistent manufacturing processes. The data and processes developed will provide
insight and direction into the ongoing test program and to meet regulatory requirements for first
clinical trial applications, anticipated in 2011. These program activities are directed by the
Company’s Clinical Advisory Group, and are being delivered under contract with independent
firms in California, Arizona, Massachusetts, New York, and in Ottawa.
The Company will provide periodic updates to the market on material test results and progress of
GAP-107B8 toward first trials in humans.
About PharmaGap Inc.
PharmaGap Inc. (TSX-V: GAP; OTC.BB: PHRGF), based in Ottawa, ON, is a biotechnology
company with a core focus on developing novel peptide therapeutics for the treatment of cancer.
PharmaGap's GAP-107B8 is a novel peptide drug designed to inhibit the activity of protein kinase
C (PKC), a cell signalling enzyme implicated in certain types and stages of cancer. Independent
peer-reviewed research has demonstrated that over-expression of PKC plays a role in the
development of many cancer types. For more information please visit www.pharmagap.com.
