WASHINGTON, D.C. -- Alpha 1 Biomedicals Inc. said Friday thatit started Phase III clinical trials of Thymosin alpha 1 to treatchronic hepatitis B.
Results of a Phase II study of Thymosin showed that nine of 12patients treated experienced remission for more than 27months. Some patients have now been in remission for morethan 36 months, said Vincent Simmon, president of Alpha 1(NASDAQ:ALBM).
More than 300,000 cases of acute hepatitis B are diagnosedannually in the United States. Between 5 percent and 8 percentof these develop into chronic hepatitis B, for which there is notreatment.
Thymosin alpha 1 is a synthetic version of a natural hormone.Although it is not known how thymosin works, Simmonspeculated that it may have two modes of action. It may act asan immunomodulator, stimulating the body's immune systemto fight the virus. Also, Thymosin causes cells to produce morealpha and gamma interferon.
The interferon may be producing a local anti-viral effect at thesite of inflammation, Simmon said. In essence, Thymosin maybe delivering interferon directly where it's needed.
Intron A alpha interferon, produced by Schering-Plough Corp.(NYSE:SGP) of Madison, N.J., appears to be the chronic hepatitisB treatment closest to market. The company filed a productlicense application with the Food and Drug Administration inSeptember 1989.
Clinical trial results of Intron A published in last August'sedition of The New England Journal of Medicine showed that 31of 85 patients experienced remissions.
Hoffmann-La Roche Inc. of Nutley, N.J., is conducting Europeantrials of its Roferon-A alpha interferon for treating chronichepatitis B. -- Karen Bernstein
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