Transition Therapeutics Inc has completed enrollment and the clinical phase for its Phase I trial of its Islet Neogenesis Therapy (I.N.T.). The trial enrolled 28 healthy volunteers for evaluation of safety, tolerability, and pharmacokinetic profile of acute escalating doses of I.N.T.'s two growth factors, E1 (0.1 ug/kg to 3 ug/kg) and G1 (3 ug/kg to 30 ug/kg). All subjects completed the escalation to the maximum exposed doses and no serious or unexpected adverse events were observed. Final clinical findings will be forthcoming.

"We are extremely pleased with the preliminary results of the Phase I study for I.N.T. and we anticipate meeting our milestone of entering into a Phase II for I.N.T. by the end of this year. Furthermore, the doses of E1 and G1 used in the Phase I study were higher than doses required to obtain efficacy in diabetic animal models," said Dr. Tony Cruz, Chairman and CEO of Transition Therapeutics Inc.

Transition received approval on September 20, 2002 to begin a dose escalation Phase I human trial in the United Kingdom for I.N.T. Dosing for this trial began in October 2002 and the clinical phase of the study finished in January 2003.

Transition believes that I.N.T. represents a new paradigm in the treatment of diabetes because it consists of a simple, non-invasive regenerative therapy that mimics the normal development of insulin producing cells. I.N.T. is a short course of injections of two well-defined human growth factors that stimulates the body to regenerate insulin-producing cells that are damaged or destroyed in those with insulin-dependant diabetes. This treatment has the potential of reducing, and in some cases eliminating the need for insulin injections.