PharmaGap Announces Start of Definitive Animal Efficacy Study Required to Proceed to Clinical Trials

OTTAWA, ONTARIO--(Marketwire - Nov. 15, 2011) - PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF)("PharmaGap" or "the Company") today announced successful completion of a Maximum Tolerated Dose ("MTD") Study and commencement of an in vivo efficacy study using human ovarian cancer in validated mouse models. This in vivo test is the definitive efficacy test in animals required for GAP-107B8 prior to proceeding to clinical trials in humans. PharmaGap expects to announce completion of these tests on or about December 20^th. Results of the tests will be announced when data compilation and analysis is completed, expected to be during January 2012.
Earlier studies in similar ovarian cancer mouse models using non-liposomal formulations of GAP-107B8 showed reduced tumour burden (19%) and a significant suppression of malignant ascites formation (73%). Malignant ascites is a significant cause of morbidity in women with ovarian cancer, and is also present in other forms of cancer as well as being associated with increased level of metastases of many cancers.
Since that result was produced, PharmaGap has successfully developed and tested liposomal formulations of its cancer drug GAP-107B8 in order to enhance efficacy at reduced dose levels.
The MTD study was designed to provide the final dose range for each of the four GAP-107B8 formulations that will be tested in the in vivo ovarian studies now underway.
The outcome of the current in vivo test will provide the Company with the basis for selection of one formulation of GAP-107B8 with which to proceed to cGMP manufacturing, GLP Toxicology studies required for clinical trial application, and the clinical trials themselves.
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.
Forward Looking Statements
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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.