OTTAWA, ONTARIO--(Marketwire - Feb. 8, 2011) - PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF) ("PharmaGap" or "the Company") announces key pillar in final stages for choice of cancer target for clinical trials.
Agreement has been reached with Northern Lipids Inc. (NLI) of Burnaby, BC to develop a liposomal delivery formulation of PharmaGap's lead cancer drug GAP-107B8 for therapeutic use in humans.
The overall program from initiation to delivery of optimized liposome formulations of GAP-107B8 to PharmaGap suitable for in-vivo studies is expected to take approximately 4 months. Initial analysis and design of the three prototype formulations is expected to be completed by June, 2011.
While the work at NLI is undertaken, testing of GAP-107B8 at collaborator sites in Ottawa (animal models of ovarian cancer, with initial results expected by April, 2011) and in Kingston, Ontario (in vitro testing in bladder cancer, with first results anticipated by May, 2011, to be followed by testing in animal models of bladder cancer) will continue.
This program is being designed and directed by Dr. Ken Sokoll, Vice President Clinical Drug Development and Chief Operating Officer of PharmaGap, in conjunction with NLI. Dr. Sokoll has extensive experience with formulation technologies including liposomal delivery systems, and views this mode of peptide formulation and delivery as an ideally suited and proven method for application to GAP-107B8. "With our test programs internally and at our collaborator sites well underway, the work to be undertaken at Northern Lipids represents a key pillar in the final stages required to lead us to our choice of optimum cancer target for first clinical trial application. I have great confidence in the ability of Northern Lipids to deliver well characterized liposomal formulations of GAP-107B8 suitable for our non-clinical development program and note they have the capacity to supply PharmaGap with scaled cGMP grade formulations, which will be required for use in human clinical trials"
Liposome delivery systems are an accepted, proven, and commercially viable strategy for the formulation of pharmaceuticals for clinical use. These lipid-based delivery systems are employed to improve tumour targeting, modulate the pharmacokinetics of the active agent and enhance its chemical stability following administration. Therapeutic activity may be improved by modulating drug exposure and accumulation (controlled release) in the region where the target cancer cells are located. The design of the liposome carriers of GAP-107B8 by NLI will be specific for three routes of administration currently being investigated by PharmaGap: topical delivery by intravesical infusion to the bladder wall; topical delivery by intraperitoneal injection for ovarian cancer; and by intravenous injection for solid tumours.
Liposomes are microscopic carriers with an aqueous core surrounded by one or more outer lipid layers, and release their contents by interacting with the targeted cells through adsorption, endocytosis, lipid exchange, or fusion. Liposomal delivery is a means to modify the pharmacokinetic and pharmacodynamic properties of drugs with the objective of increasing efficacy and mitigating any potential side effects of drugs by enabling the delivery and targeting of the drug to the target site.
About Northern Lipids Inc.
Northern Lipids Inc. (NLI), based in Burnaby, BC, is a contract research (CRO) and Manufacturing Organization (CMO) that provides Chemistry, Manufacturing and Control (CMC) services to biotechnology and pharmaceutical companies engaged in the development and manufacture of complex drug delivery systems, including liposomes, emulsions and micelles. NLI's products and services are adapted to meet the specific needs of clients, and include manufacturing development and scale-up, analytical method development and validation and sterile product manufacturing under cGMP (current Good Manufacturing Practices). With over 15 years of experience serving clients from Asia, Europe and North America, NLI has a successful track record of helping clients move their programs forward.
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.