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news.PharmaGap has reached an agreement with contract research (CRO) and manufacturing organization (CMO) Northern Lipids to develop a liposomal delivery formulation of PharmaGap's lead cancer drug GAP-107B8 for therapeutic use in humans.
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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 Northern Lipids 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.
The program is being designed and directed by PharmaGap VP of Clinical Drug Development and COO Ken Sokoll, in conjunction with Northern Lipids.
Sokoll said he has great confidence in the ability of Northern Lipids to deliver well characterized liposomal formulations of GAP-107B8 suitable for thier 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.