SciClone Pharmaceuticals Inc., in a interim report Thursday at thecompany's annual shareholders meeting, said there have been noreports of drug toxicity or adverse events in a Phase III trial in Taiwanof thymosin alpha 1 for treatment of chronic hepatitis B.Analysis of the ongoing trial included reports from 106 patients whohad been in the study up to 10 months. There are expected to be 150patients tested in the unblinded trial."While we are obviously encouraged in finding that all five patientswho have been in the 12-month treatment group for 10 months havebecome DNA negative, we should not assume the response rate willcontinue," said David Horwitz, SciClone's vice president of medicaland regulatory affairs. `We note that the six-month treatment patientsdo not, as of this time, differ from the untreated patients."SciClone, which already has received approval for the drug inSingapore (under the name Zadaxin), plans to launch it there in thefourth quarter of this year. The San Mateo, Calif., company licensedrights to thymosin alpha 1 from Alpha 1 Biomedicals Inc. and hasexclusive marketing rights to the drug everywhere but North America,Europe, Israel and Korea.On April 28, Alpha 1, of Bethesda, Md., released preliminary data fromits U.S. Phase III trial of the drug for chronic hepatitis B that showedroughly equal responses to the drug and placebo. The company saidfurther tests would be necessary before a new drug application could befiled. _ Jim Shrine
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