TORONTO, ONTARIO AND SAINT LAURENT, QUEBEC--(Marketwire - Jan. 28, 2009) - Cannasat Therapeutics Inc. ("Cannasat") (TSX VENTURE:CTH) and IntelGenx Corp. (OTCBB:IGXT) (TSX VENTURE:IGX) ("IntelGenx"), announced today that Health Canada has approved Cannasat's clinical trial application for a Phase 1(b) clinical study with its lead product, CAT 310. Cannasat 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.
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.
This Phase 1(b) 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. Enrolment in Canada for this trial is expected to begin in February 2009.
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."
Dr. Horst Zerbe, President and CEO of IntelGenx added "The anticipated successful completion of this clinical study will once again confirm IntelGenx's unique expertise in the formulation development of complex drug delivery technologies."
Neuropathic pain is associated with nerve damage and can be an especially difficult to treat condition, often requiring the use of strong narcotics that can cause serious adverse effects. This condition is can be caused by many common diseases such as diabetes, herpes zoster, HIV/AIDS, multiple sclerosis, and other causes of chronic pain. Most patients require treatment with multiple drugs and often achieve only partial relief. It is estimated that over 15 million people suffer from some variety of neuropathic pain in North America and Europe.
ABOUT CANNASAT THERAPEUTICS
Founded in 2004, Cannasat is an early stage CNS (Central Nervous System) research and development company. Cannasat's current drug candidates have broad potential therapeutic applications, including the treatment of neuropathic pain, chronic pain, nausea/vomiting, anxiety, schizophrenia, and other mood disorders. More information about Cannasat (TSX VENTURE:CTH) is available at www.cannasat.com.
ABOUT INTELGENX CORP.
IntelGenx Corp. is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. The Company uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastro-intestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. The Company's research and development pipeline includes products for the treatment of pain, hypertension, osteoarthritis, and depressive disorders. More information is available about the company at www.intelgenx.com.
FORWARD LOOKING STATEMENTS
Certain statements in this release may constitute forward-looking statements. Such forward-looking statements involve risks, uncertainties and other factors, which may cause actual results, performance or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements.
FOR FURTHER INFORMATION PLEASE CONTACT:
Cannasat Therapeutics Inc.
COO & CFO
(416) 703-2449 (Ext. 253)
(416) 703-8752 (FAX)
Dr. Horst G. Zerbe
President and CEO
(514) 331-7440 (ext. 201)
(514) 331-0436 (FAX)