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news.Cannasat Therapeutics, a clinical stage pharmaceutical company, and IntelGenx, a drug delivery company, have announced that Health Canada has approved Cannasat's clinical trial application for a Phase Ib clinical study with its lead product, CAT 310.
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Cannasat has received a no objection letter from Health Canada to conduct this clinical study for this product that is designed to help manage neuropathic pain and other disorders.
This Phase Ib trial is a randomized, single dose, crossover study comparing a prototype buccal tablet to oral Marinol in normal healthy male volunteers. The primary objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of the CAT 310 prototype. Enrollment in Canada for this trial is expected to begin in February 2009.
CAT 310 was formulated using IntelGenx’s proprietary Mucoadhesive Tablet technology. It may provide significant benefit to patients by themselves or in conjunction with other classes of approved drugs, such as opiates and anticonvulsants, for the treatment of neuropathic pain.
David Hill, CEO of Cannasat, said: We are very pleased that Health Canada has expeditiously approved our clinical trial application. This is a confirmatory trial to show safe and effective absorption of dronabinol from the buccal cavity and successful results will mean a significant leap forward in Cannasat’s development plans for CAT 310 in neuropathic pain.