PharmaGap Sets Time for in Vivo Tests
OTTAWA, ONTARIO--(Marketwire - Oct. 27, 2011) - PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF)("PharmaGap" or "the Company") reported today that in vivo ("in life") efficacy testing of its GAP-107B8 cancer drug, in original, enhanced and liposome formulated versions, is scheduled to begin on or about November 13, 2011. In this efficacy study, the PharmaGap drug compounds will be tested in validated mouse models for ovarian cancer, using 3 human ovarian cancer cell lines across a total of 168 mice including treated and control groups. The treatment periods for the three cell lines will be staggered, and will run through the third week of December.
Prior to this, the Company will undertake a Maximum Tolerated Dose ("MTD") study in order to finalize the dose level range for the efficacy study. The MTD study will evaluate the tolerability of PharmaGap's formulations in a repeat dosing design suitable for use in efficacy models and is scheduled to begin on October 28.Following the treatment period, compilation of all data, including in-life observations along with histology and pathology examination observations will be analyzed in order to inform the Company as to the preferred formulation of GAP-107B8 with which to proceed to clinical trials.
While this test program is undertaken, the Company is proceeding aggressively in discussions with candidates for its cGMP ("current Good Manufacturing Practices) manufacturing development program, and with clinical trial contract research organizations for development (and eventual delivery) of protocols for PharmaGap's first clinical trial. These three elements (in vivo efficacy results, manufacturing, and clinical trial protocol) will converge to provide the basis to undertake the required GLP (Good Laboratory Practices") Toxicology program using cGMP grade material, and to the continued generation and compilation of all data required for inclusion in its clinical trial application.
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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