PharmaGap Inc.
OTC Bulletin Board : PHRGF

PharmaGap Inc.

February 03, 2012 08:00 ET

PharmaGap In Vivo Study Results Include Indication of 80% to 88% Reduction in Ascites, 62% Reduction In Tumour Burden in Ovarian Cancer Models

OTTAWA, ONTARIO--(Marketwire - Feb. 3, 2012) - PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF) ("PharmaGap" or "the Company") today announced results from the most recent testing of its cancer drug Gap107B8 in mouse models of human ovarian cancer.

The PharmaGap drug was tested in head to head comparisons against Carboplatin in-vivo using cancer cell lines OCC-1, A2780cp and ES-2. Carboplatin, a chemotherapy drug, is an example of the current standard of care for ovarian cancer. For the first time, proprietary Pharmagap liposomal formulations of Gap107B8 were used. Trends reported with respect to reduction of tumour weight or ascites are expressed relative to the untreated control group.

Ascites reduction in the OCC-1 model using the liposomal formulations ranged from 80-88%. In comparison the Carboplatin control group was found to reduce ascites by 42%. Peritoneal ascites is a significant cause of morbidity in women with ovarian cancer, and is associated with other cancers and gastrointestinal diseases, representing expanded clinical potential. Tumour burden in the OCC-1 model was reduced by 62% with enhanced Gap107B8 whereas Carboplatin reduced tumour burden by 72%.

The primary objectives of this test were to inform the Company as to the choice of the principal lead candidate for the active pharmaceutical ingredient (the "API"), and, for the first time, to test the efficacy of the Company's proprietary liposomal formulations of the APIs in a mouse model of human ovarian cancer, using an established ovarian cancer cell line (OCC-1) which the Company had previously examined with unformulated APIs alone.

Although the results in the OCC-1 model have provided evidence for several potential trends, the investigators conducting the studies have identified a number of procedural issues in the study implementation that resulted in an inability to reach statistical significance for the data set. The Company plans to repeat portions of this test protocol at an independent testing laboratory in order to generate data in which statistical significance can be demonstrated.

As a secondary objective, two additional human ovarian cancer cell lines (A2780cp and ES-2, described below) were evaluated in order to further characterize the performance of both the APIs and the liposomal delivery platform in human ovarian cancer cell lines with differing characteristics.

In the chemo-resistant A2780cp cell line model, Carboplatin achieved modest tumour burden reduction at 31%, which is not unexpected given the chemo-resistant nature of this cell line. In this first test for the PharmaGap liposomal formulation, tumour burden reduction was 22%. Further refinement in dose levels and administration cycles will be considered in order to explore and expand the potential efficacy of the PharmaGap compounds in this cell line.

The study using the ES-2 cell line was not allowed to continue through its full 15 day course of treatment with the PharmaGap compounds, having been terminated 4 days early due to respiratory difficulties found in 2 mice from the untreated control group and in 1 mouse from treatment groups. The investigators concluded that the cause of the respiratory difficulties leading to early euthanasia was likely not associated with treatment by the PharmaGap compounds.

Commenting on these results, Dr. Ken Sokoll, Vice President Clinical Development and Chief Operating Officer for PharmaGap, said "The findings from this study demonstrate that repeat administration of peptide loaded liposomes is tolerable at doses exceeding the Maximum Tolerated Dose of the corresponding unformulated peptides. This provides significant additional evidence for an expanded therapeutic index, an important milestone for clinical development of the GAP-107B8 peptide platform. We have obtained new data in the OCC-1 model for the enhanced peptide analogs of GAP-107B8, showing in-vivo trends for reducing tumour burden with concomitant reduction of ascites. Similarly, for the first time, liposomal peptide formulations have been tested and results have demonstrated potential towards reducing tumour burden and improvement in the reduction of ascites. With respect to new cell lines we have early indications for liposome formulations in a chemo-resistant A2780cp mouse model. This study, for both the OCC-1 and A2780cp models, produced results which compare favourably against Carboplatin, considered an example of standard of care."

PharmaGap drug compounds tested in this study included formulations of GAP-107B8 peptides in liposomal formulations, in a targeted liposomal formulation, and an enhanced variant of GAP-107B8 peptide alone. The study investigated the efficacy of these compounds in models of the three human ovarian cancer cell lines established in a total of 168 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 scheduled 12 day treatment period and 15 day total test period.

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

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.

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