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Transition Therapeutics Completes its Phase I Clinical Trial of its Interferon Enhancing Therapy

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May 21, 2003
PRNewswire
SOURCE Transition Therapeutics Inc.
Toronto

Transition Therapeutics Inc. announced today that it has completed enrollment and dosing for its Phase I human clinical trial of its interferon enhancer ("EMZ701"). Twenty healthy volunteers were enrolled in the study to evaluate the safety and tolerability of EMZ701. All of the safety data collected indicated that treatment was well tolerated with no safety concerns raised. No significant adverse events were observed. Final clinical findings will be forthcoming.

"The data clearly suggests that EMZ701 has a excellent safety profile and is an ideal candidate for Phase II clinical development," said Dr. Tony Cruz, Chairman and CEO of Transition Therapeutics Inc.

Transition's interferon enhancing therapy was significantly more effective than interferon alone in reducing both symptoms and pathologies associated with MS in different animal models. In addition, interferon enhancing therapy has been shown to have more potent anti-viral and anti- proliferative effects than interferon alone and therefore may have applications in Hepatitis C, Hepatitis B and Cancer. Interferon is the current standard in the treatment of MS and is also used for the treatment of Hepatitis C, Hepatitis B and Cancer. Worldwide sales of interferon are estimated to be approximately US $5.3 billion.

About Transition Therapeutics

Transition Therapeutics Inc. is a biopharmaceutical company focused on the development of regenerative therapies. The company is developing innovative therapeutics for the treatment of diabetes, multiple sclerosis, stroke and restenosis. Transition's lead products include its Islet Neogenesis Therapy (INT) for the treatment of diabetes and its Interferon Enhancing Therapy for the treatment of Multiple Sclerosis, Hepatitis B, Hepatitis C and Cancer. Both of these products have completed the clinical stage of Phase I human trials and based on their safety profile and efficacy in animal models are expected to enter Phase II trials in 2003. In addition, the company has a lead compound inhibiting restenosis induced by stenting that is expected to enter final validation studies in standard animal models for restenosis by the end of 2003. Transition Therapeutics' shares are listed on the TSX Venture Exchange under the symbol "TTH".

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