OTTAWA, ONTARIO--(Marketwire - Dec. 21, 2011) - , 2011 - PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF.PK - News) ("PharmaGap" or "the Company") today announced that the in-life protocol for its definitive in vivo efficacy study has been completed in accordance with the test design. In this test, a total of 168 mice were employed, with the final group euthanized on December 16th. The investigators will now turn to collection, measurement, compilation and analysis of results, which are expected to become available to the Company around the end of January.
Results from this study will provide the Company with the in vivo efficacy proof of concept required to proceed to clinical trials in humans and with the basis to select a final formulation and liposomal carrier with which to proceed to large scale GMP manufacturing for use in human trials.
PharmaGap drug compounds tested in this study included GAP-107B8 in a liposomal formulation, GAP-107B8 in a targeted liposomal formulation, and an enhanced variant of GAP-107B8 alone and in a liposomal formulation. The study investigated the efficacy of these compounds in models of three human ovarian cancer cell lines established in mice. Cancer cells were introduced into the mice by intraperitoneal injection in order to establish and grow tumours of that cancer cell type. The Pharmagap drug compounds were administered to the mice by intraperitoneal injection up to 5 times over a 12 day treatment period.
One of these cell lines - OCC1 - was selected because it is known to form primary peritoneal ascites and small tumour nodules following intraperitoneal xenograft into immune-deficient mice. The initial in vivo screen of this cell line was performed in June of 2011 and provided early evidence that PharmaGap's enhanced peptides could be effective when administered via the intraperitoneal route. The second cell line - ES-2 - has also been associated with the production of peritoneal ascites and solid tumours. The third cell line - A2780cp - was chosen on the basis that it is a chemotherapy-resistant cell line associated with undifferentiated solid tumours and negligible production of ascites. Evaluation of this cell line allows the Company to investigate the potential therapeutic efficacy of the drug compounds and formulations in the most challenging clinical scenario, treatment of chemo-resistant ovarian cancer. Peritoneal ascites is a significant cause of morbidity in women with ovarian cancer, and is also present in other forms of cancer, is associated with increased level of metastases of many cancers, and is also present in other gastro-intestinal disease conditions.
Following euthanization, peritoneal ascites fluid is collected (in the case of the OCC1 and ES-2 cell lines), and the volume determined for each treatment group. All detectable tumour tissue is retrieved, weighed, and noted for the degree of dissemination of the tumours. Samples of tumour tissue and normal abdominal wall tissue are retained for analysis.
Analysis of the data will generate graphs of tumour burden and of ascites volumes in order to compare the effect of the three PharmaGap formulations, the liposomal carrier without the PharmaGap drug compound embedded, and carboplatin, a chemotherapy drug used in ovarian cancer treatment included as a positive control, all relative to an untreated control group.
The Company will report on the findings of the investigators around the end of January following receipt and complete analysis of all test data and observations.
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 effective in 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
This news release contains certain statements that constitute forward-looking statements as they relate to the Company and its management. Forward-looking statements are not historical facts but represent management's current expectations of future events, and can be identified by words such as "believe", "expects", "will", "intends", "plans", "projects", "anticipates", "estimates", "continues", and similar expressions. Although management believes that expectations represented in such forward-looking statements are reasonable, there can be no assurance that they will prove to be correct.
By their nature, forward-looking statements include assumptions and are subject to inherent risks and uncertainties that could cause actual future results, conditions, actions or events to differ materially from those in the forward-looking statements. If and when forward-looking statements are set out in this news release, PharmaGap will also set out the material risk factors or assumptions used to develop the forward-looking statements. Except as expressly required by applicable securities laws, the Company assumes no obligation to update or revise any forward-looking statements. The future outcomes that relate to forward-looking statements may be influenced by many factors, including, but not limited to: results of ongoing product testing and development; regulatory approvals required to complete development of products; ability to manufacture product at quality and scale for human use on an economically sound basis; patient reimbursement by private and public health insurance programs; unintended side effects of products; competitive products; product liability; intellectual property; reliance on key personnel; risks of future legal proceedings; income tax matters; availability and terms of financing; distribution of securities; effect of market interest rates on price of securities, and potential dilution.
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