PharmaGap Inc. 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.