Alpha 1 Biomedical Inc. is conducting Phase III clinical trials ofthymosin alpha 1 in the U.S., where the agent is being studiedfor the treatment of hepatitis B and C.

Alpha 1 of Bethesda, Md., has granted exclusive marketingrights for Thymosin alpha 1 to SciClone Pharmaceuticals Inc. ofSan Mateo, Calif., for all countries outside of North America,Europe, Korea and Israel, according to a SciClonerepresentative.

Thymosin alpha 1 was approved for the treatment of chronichepatitis B in Singapore last September under the brand nameZadaxin, but SciClone has not yet been able to market the drugbecause of supply problems. The two companies are currentlyin arbitration over supply, manufacturing and royalty issues,the SciClone representative said.

SciClone announced Thursday that it has begun a study ofthymosin alpha 1 in 100 asymptomatic hepatitis B patients.The trial will compare patients treated with the agent for six to12 months with patients on placebo, looking for thedisappearance of the hepatitis B virus DNA from serum.SciClone estimated that 60 percent of all hepatitis B carriers areasymptomatic. Asymptomatic patients do not have liverinflammation associated with the chronic form of the disease,but remain at risk for late complications such as liver cancerand cirrhosis.

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