Canadian Co Tests Puffer Fish Drug for Pain

Investigators involved in the pivotal clinical trial of Tectin™ enrolled and dosed the first of up to 150 patients that will participate in the study.

It is one of the largest Canadian clinical trials to evaluate the efficacy and safety of a drug for treatment of medically refractory cancer pain, and will take place in up to 25 treatment centres across Canada .

Tectin™, a drug derived from the puffer fish, also known as blow fish or fugu, has been developed by Vancouver-based International Wex Technologies Inc. to block slow sodium channel nocicipetive pain fibers in a highly selective manner.

Results from a recently completed open-label Phase IIa dose finding study will be presented in a podium presentation by the lead investigator, Dr. Neil Hagen, during the 2nd Joint Scientific Meeting of the American Pain Society and the Canadian Pain Society that will be held in Vancouver, B.C., on May 6-9, 2004 .

As previously announced, interim results from this study showed Tectin™ to be safe and effective in refractory cancer pain with 68% of the test subjects demonstrating a clinical response that lasted for longer than two weeks in some patients.

Based on these promising results, the Company was encouraged to pursue a larger trial to further confirm the effectiveness of the compound.

The current trial is a multicentre, randomized, double-blind and placebo-controlled study designed to compare the efficacy and safety of Tectin™ versus placebo in moderate to severe inadequately controlled cancer-related pain.

The study is co-led by Dr. Neil Hagen and Dr. Bernard Lapointe. Dr Neil Hagen is a nationally respected leader in cancer pain assessment and management, who currently heads the Division of Palliative Medicine, Department of Oncology, and Faculty of Medicine, at the University of Calgary.

Dr. Bernard Lapointe is Chief, Palliative Care Division, Sir Mortimer B Davis Jewish General Hospital Montreal and an Associate Professor, Department of Oncology & Department of Family Medicine at McGill University .

Dr. Benard Lapointe states “We are very encouraged by results of the previous study. Tectin™ is very promising particularly for cancer patients presented with severe pain or pain not responding to other drugs.

The Phase IIb/III pivotal study might be the most important clinical study on cancer pain conducted in Canada and the research team at the Jewish General, one of Canada 's most active cancer research centres, is proud to be initiating them.”

In cancer particularly, there is need of pain medications that are effective, easily administered, and non-addictive.

Animal studies showed that Tectin™ is much more potent than standard opioids, non-addictive, and furthermore the product can be given subcutaneously, thus preventing complications with patients suffering from nausea or other conditions that may interfere with the oral administration of an analgesic.

Wex originally used the drug compound for the treatment of drug withdrawal but it was noted that the main factor in its ability to relief or eliminate withdrawal symptoms was its ability to reduce pain.

Thus, Wex pursued testing of Tectin™ for refractory cancer relief in cancer patients. With these encouraging results, Tectin™ will also be investigated for clinical use in patients suffering from non-cancer chronic pain.

The Pivotal trial of Tectin™ in cancer pain is expected to continue for the next 12 months, with interim results expected in 2005.

International Wex Technologies Inc., a publicly listed neuro-bioscience company (WXI), is focused on the development and commercialization of innovative drug products, primarily for pain management. The Company's lead compound, Tetrodotoxin, is a sodium channel blocker and is the platform for the Company's development of a portfolio of proprietary products in the field of analgesia, drug addiction withdrawal treatment, and local anaesthesia.

For additional information on our products visit us at http://www.wextech.ca

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