PharmaGap Inc.
TSX VENTURE : GAP
OTC Bulletin Board : PHRGF

PharmaGap Inc.

April 05, 2011 08:46 ET

PharmaGap Preparing for Clinical Trials

OTTAWA, ONTARIO--(Marketwire - April 5, 2011) - PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF) ("PharmaGap" or "the Company") expects to complete this year the selection of the target cancer for clinical trials and to commence production of formulated drug for use in these trials. "We are in the final stages of pre-clinical work", Mr. Robert McInnis, CEO for PharmaGap said. "We will be reporting frequently through this year as work progresses to lead us to clinical trials next year. We are encouraged by recent transactions in our industry indicating that the strategy of carrying our work through Phase One Trials can establish the basis for very meaningful value and returns to our shareholders who have provided funding for this work over many years".

The Company's lead cancer drug, GAP-107B8, has previously been successfully tested in both in vitro and in vivo models using a range of cancers.

PharmaGap is engaged in a program during 2011 leading to application for initial clinical trials in 2012. This program is directed by Dr. Ken Sokoll, Vice President, Clinical Development and Chief Operating Officer. A principal objective for 2011 is the selection of a single cancer target, using a specific route of administration and dosing levels for that target, for the initial clinical trial. Ovarian cancer and bladder cancer will continue to be assessed, using formulated versions of the drug and alternate routes of administration found in clinical settings.

Based on observations to date, a liposomal formulation approach has been chosen in order to provide optimal stability and effectiveness for PharmaGap's lead peptide drug GAP-107B8. Activities are now underway within PharmaGap and at a number of Contract Research Organizations to develop and finalize the formulation. In order to provide the best possible opportunity for success in clinical trials, the company has decided to continue to focus work on both bladder and ovarian cancer through Q2 and Q3 and into Q4 with a view to selecting the clinical trial candidate in Q4 of this year. The liposomal formulations of GAP-107B8 and three clinically-accepted routes of administration will be tested to provide the best possible basis to select the specific cancer target, route of administration, and dosing levels to proceed to clinical trials. Results of both formulation and animal tests will be announced as they become available.

The Contract Manufacturer for the drug is expected to be selected during the second quarter of this year for production of the final form of the drug compound to meet quality, stability, and quantity requirements for use in final pre-clinical testing and for clinical trials. The Company expects to commence production of the drug in the second half of 2011 for use in final testing in order to support filing of applications for approval of initial clinical trials in 2012.

While clinical trials are underway the Company will undertake a program to identify additional cancer targets for future clinical trials in order to expand the potential commercial market for GAP-107B8.

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

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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