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Published on 12/5/2005 in the Prospect News Biotech Daily.

Transition Therapeutics sees positive initial data on E1-I.N.T. for diabetes

New York, Dec. 5 - Transition Therapeutics Inc. said that initial results from its ongoing phase 2a clinical trial of E1-I.N.T. for diabetes showed a reduction in daytime insulin usage and a favorable safety profile when the therapy was titrated to maximal doses.

The announcement is based on preliminary data from the first four type I diabetes patients to complete the four-week treatment period using either E1-I.N.T. or a placebo.

"Although preliminary and blinded, these interim data show diabetes patients tolerating escalating doses of E1-I.N.T. treatment and three of four type I diabetes patients reducing their daytime insulin usage by 35%-75%." said Sherwyn Schwartz, director of Diabetes and Glandular Disease Research Associates in San Antonio, in a news release. Schwartz enrolled these first patients in the study.

E1-I.N.T. is being evaluated in an ongoing exploratory phase 2a clinical study for type I and type II diabetes patients as well as blinded safety and efficacy data for the type I diabetes clinical study. The main objective is to identify well-tolerated and safe doses and signs of efficacy by measuring parameters including insulin usage and HbA1c levels.

E1-I.N.T. is a short course combination therapy aimed at stimulating the regeneration of islet cells, which produce insulin.

Eventually, the phase 2a trial will examine 20 type I diabetes patients and 30 type II diabetes patients. Final results are expected in the middle of 2006.

Transition Therapeutics is a Toronto-based biopharmaceutical company.


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