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Published on 4/21/2006 in the Prospect News Biotech Daily.

Transition interim trial data shows HCV-I.E.T. reduces hepatitis C virus levels

By Lisa Kerner

Erie, Pa., April 21 - Transition Therapeutics Inc. said 12-week data from its open-label, multi-center phase 1/2 clinical trial evaluating HCV-I.E.T. in hepatitis C non-responders demonstrated that 63% (7 of 11) of the patients had a 90% or greater reduction in hepatitis C virus levels.

Another 27% (3 of 11) of patients achieved a greater than 99% reduction in virus levels, according to a company news release.

HCV-I.E.T. combines Transition's interferon enhancer, EMZ702, with a combination therapy of pegylated interferon alpha and ribavirin.

The trial, ongoing at five clinical sites in Canada, will evaluate safety and HCV-I.E.T.'s ability to produce a positive therapeutic response in patients who are chronically infected with the hepatitis C virus (HCV genotype 1) and have failed to respond to treatment with pegylated interferon and ribavirin, the current standard of care for the disease.

Of the 25 patients enrolled in the trial, 11 have completed the 12-week treatment with HCV-I.E.T.

Hepatitis C non-responders, or about 45% of all hepatitis C patients, currently have no treatment alternatives available for this progressive liver disease, according to the release.

"It is encouraging to see substantial viral reductions in the hepatitis C non-responders, a large population of patients facing many long-term complications from the disease including cirrhosis, liver failure and liver cancer," chairman and chief executive officer Tony Cruz said in the release.

Transition is a Toronto-based biopharmaceutical company.


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