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Message: Cannasat and IntelGenx Announce Positive Phase 1(b) Results

Cannasat and IntelGenx Announce Positive Phase 1(b) Results

posted on Apr 14, 2009 06:59AM
April 14, 2009
Cannasat and IntelGenx Announce Positive Phase 1(b) Results Improved Buccal Tablet Outperforms Oral Dronabinol
TORONTO, ONTARIO--(Marketwire - April 14, 2009) - Cannasat Therapeutics Inc. ("Cannasat") (TSX VENTURE:CTH), and its development partner IntelGenx Corp. (TSX VENTURE:IGX) (OTCBB:IGXT) ("IntelGenx"), today announced positive results for the Phase 1(b) clinical trial of Relivar, the first buccal dronabinol drug delivery product, which was developed using IntelGenx' proprietary AdVersa buccal delivery technology. Buccal delivery allows for drug absorption from the mouth directly into the bloodstream as opposed to the intestinal tract absorption seen with oral tablet technologies.

"These results conclusively show successful delivery of dronabinol in a buccal dosage form," said David Hill, Chief Executive Officer of Cannasat. "This study proves to us that Relivar has the potential to be a commercially viable product for treatment of neuropathic pain, chemotherapy nausea/vomiting, and possibly other conditions. The cumulative size of these markets exceeds $4 billion annually with the neuropathic pain market experiencing the most growth in recent years. Relivar's buccal delivery of dronabinol will allow for more flexible dosing with potentially fewer side effects."

In this latest clinical trial, Relivar delivered twice the amount of dronabinol into the bloodstream versus the reference drug Marinol (as measured by AUC) with no increase in adverse events. The randomized, single dose, double crossover study compared Cannasat's Relivar to the reference oral dosage form of dronabinol (Marinol) at 2.5 mg in healthy volunteers. Relivar was well-tolerated with no adverse events noted in this study. Relivar met its primary goal of delivering a greater dose of the drug through the buccal mucosa versus the reference compound, Marinol, which is swallowed and has an intestinal absorption mechanism. Relivar also showed nearly a 50% reduction in the ratio of 11-OH-THC to the parent drug versus oral dronabinol in the same subjects. Literature suggests that the 11-OH-THC metabolite, which is also a marker of absorption in the gut, is responsible for the pronounced CNS adverse events of oral Marinol (or dronabinol). Relivar also showed an extended absorption profile which may be advantageous for more convenient dosing.

Hill also outlined Cannasat's next steps: "We now plan to confirm our 505b2 regulatory pathway via a pre-IND meeting with the US FDA."

"We are particularly excited about the results of this study because it proves the effectiveness of AdVersa, our proprietary buccal delivery technology," said Dr. Horst Zerbe, President and Chief Executive Officer of IntelGenx. "We have again demonstrated our ability to improve existing medications. I have the utmost confidence in the IntelGenx technologies to deliver the desired results in a wide range of possibilities. We are especially pleased to have this opportunity to team up with Cannasat in developing an improved delivery form for dronabinol."

About Cannasat Therapeutics

Cannasat is a clinical stage pharmaceutical company developing products to treat neurological disorders such as neuropathic pain and schizophrenia. Cannasat currently has two new drugs in its pipeline: Relivar (formerly CAT 310) and Modulyn (formerly CAT 320). Over the next 12 months Cannasat plans to advance Relivar and Modulyn with further clinical testing and is positioning itself to enter marketing agreements with select Pharma partners. Pharma collaborations will create a pathway towards the future commercialization, as well as provide important new investment to develop our pipeline of additional CNS/neurology product candidates. 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.
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