PharmaGap Inc. Announces Successful Result From Toxicity Phase Of Latest Testing
Published: Oct 14, 2010
OTTAWA, ONTARIO--(Marketwire - October 14, 2010) - PharmaGap Inc. (TSX VENTURE: GAP)(OTCBB: PHRGF) ("PharmaGap" or "the Company") today announced positive results from the toxicity phase of testing of the Company's cancer drug GAP-107B8 at LAB Research Inc. ("LAB") of Montreal, PQ.
GAP-107B8 showed no signs of toxicity in rats using continuous infusion intravenous administration (other than minimal local tissue irritation at the site of the injection in the highest dose groups) at dose levels greater than dose ranges previously shown to be effective in reducing tumour burden in mice using bolus intravenous injections.
The study has provided important evidence for the tolerability of GAP-107B8 as a function of concentration and systemic exposure. The continuous infusion intravenous injection method of administration mimics a commonly used method of administration of cancer drugs in humans.
Rats administered GAP-107B8 via continuous infusion intravenous injection over a two hour time period, at doses of 10, 20 and 40 mg/kg of body weight, showed no apparent signs of toxicity from in-life observations (48 hours following administration) other than local tissue irritation at the site of injection in the highest dosed groups. No apparent signs of toxicity were found from clinical pathology analysis of blood samples taken immediately prior to euthanasia or from examination of internal organs following euthanasia for all dosed groups. The study employed a total of 80 rats, with 20 in each dosing group plus a control group of 20. Significantly, all rats in all dosed groups survived to the time of scheduled euthanasia.
During the in-life phase of study, blood samples were taken at 15, 60 and 120 minutes after start of infusion, and then at 5, 15, 30, 60 and 120 minutes post- infusion. The toxicokinetic data acquired will provide PharmaGap with key insights into formulation and delivery strategies for development of the clinical testing program for GAP-107B8. Final reports and toxicokinetic (rate of distribution, metabolism and excretion) analysis of plasma samples are expected to be completed in 6 to 8 weeks time.
Dr. Ken Sokoll, the Company's Vice President, Clinical Development and Chief Operating Officer, commented "These results will provide us with the ability to refine the design of future repeat dose toxicokinetic studies which are required in support of our clinical development program. Also significant is our decision to undertake this study at LAB Research Canada located in Montreal, a CRO which has the capability of delivering testing programs in full compliance with GLP - good laboratory practices. Future pivotal toxicology and safety-pharmacology studies for GAP-107B8 will be executed following GLP, a requirement expected by regulatory bodies considering applications for Phase I clinical trials and by licensing partners in assessing our product dossier for in-licensing. "
About PharmaGap Inc.
PharmaGap Inc. (TSX VENTURE: GAP), 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 that has been shown to be highly cytotoxic to numerous cancer types, including chemo-resistant cancers, in vitro. For more information on PharmaGap please visit the Company's website at www.pharmagap.com.
Note: Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts 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.
President & CEO
Dr. Ken Sokoll, Vice President
Clinical Development and Chief Operating Officer