OTTAWA, ONTARIO--(Marketwire - October 05, 2010) - PharmaGap Inc. (TSX VENTURE: GAP)(OTCBB: PHRGF) ("PharmaGap" or "the Company") today provided guidance on the Company's clinical development program for its lead cancer drug GAP-107B8 for the fourth quarter 2010 and into 2011.
Robert McInnis, President and C.E.O. of the Company, commented "The discovery phase is completed and the clinical drug development program is underway to take GAP-107B8 into clinical trials. Dr. Ken Sokoll joined the Company as Vice President Clinical Development and Chief Operating Officer on September 1, 2010 and leads this program. We anticipate achieving a series of milestones over the remainder of 2010 and into 2011. We are also taking steps to ensure that the pharma licensing community is actively engaged in reviewing new data and test results as they are generated."
In the first half of 2010, the Company focused its development efforts on completion of the discovery phase of development of GAP-107B8. This includes test programs undertaken at the Ottawa Hospital Research Institute ("OHRI") using ovarian cancer models in human cancer cells ("in vitro") and in human cancer tumours established in mice ("in vivo"), at Memorial Sloan Kettering Cancer Centre in New York using in vitro models of carcinomas and sarcomas. In addition, a 60 cancer cell in vitro test was conducted at the National Cancer Institute in Bethesda MD ("NCI"). Each of these tests has added to the body of evidence that GAP-107B8 has a strong and consistent effect limiting growth of both human cancer cells and tumours established in mice, within a tolerated dose range. This testing program provides independent confirmation by recognized research institutions of test results previously generated internally at PharmaGap. Details of these test results have previously been announced.
For Q4, the clinical development program will focus on the selection of the optimal cancer target for initial human testing, based on a determination of the optimal delivery mechanism for GAP-107B8 for reaching the target cancer at safe and effective dose levels. To achieve this, a series of testing and method development activities will be carried out internally and with the Company's collaborators. Specific test programs expected to be commenced during the 4th quarter include:
-- continuous infusion pharmacokinetics studies in rats currently underway
at LAB Research in Montreal;
-- human melanoma and sarcoma cancers in a mouse model in collaboration
with Memorial Sloan Kettering Cancer Center in New York;
-- human ovarian cancers in a mouse model at the Ottawa Hospital Research
Institute in Ottawa;
-- human bladder cancers in a mouse model using novel method of delivery,
in conjunction with collaborators to be announced; and
-- development of various assays at PharmaGap to guide the design and
delivery of the clinical development program.
Testing programs during the remainder of 2010 will provide data requested by pharma licensing contacts. The Company will be in a position to continue and to advance discussions aimed at licensing of the product during the course of undertaking Phase I and Phase II Clinical Trials. The Company's intention is to maintain the ability to proceed through and complete Phase II Clinical Trials in order to drive the value of a licensing transaction to the highest level possible. However, earlier licensing will be accepted if risk-adjusted valuation targets are met.
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 managements current expectation 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 the 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 law, 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: the ability to secure licensing arrangements; successful development of PharmaGap's drug products for human use; competition from alternate therapies; product liability; intellectual property; reliance on key personnel; interest rates; uninsured and underinsured losses; operating hazards; risks of future legal proceedings; 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.