Alpha 1 Biomedicals Inc. said it has begun Phase III clinicaltrials of Thymosin alpha 1 in combination with recombinantinterferon alpha for the treatment of chronic hepatitis C.
The goal of the trial at the Fitzsimons Army Medical Center inAurora, Colo., is to determine if Thymosin can improveremission rates reported for Intron A interferon, which wasapproved for treatment of hepatitis C in February.
The overall remission rate in Intron A trials has been about 25percent, and interferon causes "significant flu-likesymptoms," said Dr. Vincent Simmon, president and chiefexecutive officer of the Washington, D.C.-based Alpha 1(NASDAQ:ALBM).
"Thymosin by itself does not cause these symptoms, and weare not aware of any evidence that, in combination, Thymosinmakes the interferon symptoms any better or worse," Simmontold BioWorld. "We are hoping that Thymosin by itself wouldprovide a sufficient percentage of remission that it would beused as a sole therapy."
Thymosin is also in Phase III trials for use against hepatitis B.
More than 1 million people in the United States have chronichepatitis C and 500,000 to 1 million have hepatitis B. Becausea course of interferon therapy costs $4,000 to $5,000, thepotential market is $6 billion to $10 billion, according toSimmon. "We think capturing 10 to 20 percent of the marketfor either hepatitis B or C treatments would be achievable," hesaid.
Alpha 1 also is planning tests similar to phase II clinicals inwhich only Thymosin alpha 1 and a placebo will be used totreat hepatitis C, using different dosages and durations oftreatment.
-- Kris Herbst BioWorld Washington Bureau
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