Alpha 1 Biomedicals Inc.'s thymosin alpha 1 effectively treatschronic hepatitis B, according to results of a Phase II clinicaltrial published Thursday in the journal Hepatology.
The trial compared thymosin fraction 5, which is an extract ofbovine thymus, with thymosin alpha 1 and a placebo. Alpha 1'sTA-1 is a synthetic peptide version of TF5.
Chronic HBV can result in liver failure, cirrhosis or livercancer. It occurs in 5 percent to 8 percent of the 300,000cases of acute HBV that occur annually in the United States.
Alpha 1 (NASDAQ:ALBM) of Washington, D.C., began Phase IIItrials of TA-1 in January.
In the Phase II trial, six of the seven patients treated withTA-1 or TF5 went into remission. Remission has beensustained for more than 32 months following completion of thestudy in 1989. Of the five patients given placebo, one wentinto spontaneous remission. Neither drug showed significantside effects.
According to the paper, the most efficacious anti-viralcurrently available to treat HBV is interferon alpha, whichinduces remission in fewer than 50 percent of patients and hassignificant side effects.
The authors, led by Milton G. Mutchnick of the department ofmedicine at Wayne State University in Detroit, speculated thatTA-1 and TF5 may work by modulating immune responses,possibly in a manner similar to interferon alpha.
-- Karen Bernstein BioWorld Staff
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