Data was presented this week showing that SciClonePharmaceuticals Inc.'s thymosin alpha 1 in combination withinterferon was effective in separate studies in hepatitis B and Cpatients.
The San Mateo, Calif., company's chairman and CEO, ThomasMoore, also told BioWorld that launch of the product for hepatitis Bin Singapore, where it has been approved, likely will be around theend of March. SciClone had been shooting for launch in this year'sfourth quarter.
Data from both studies were presented in Chicago at the 45th AnnualMeeting of the American Association for the Study of LiverDiseases.
One of the studies was a randomized, placebo-controlled, double-blind Phase III trial in chronic hepatitis C patientsreceiving a combination therapy of thymosin alpha 1 and interferon-alpha 2B. A life-table analysis showed nearly 50 percent of 65combination-treated patients had normalization of ALT (serumalanine aminotransferase) compared to less than 20 percent in theinterferon-only group. At the end of six-month therapy, thecombination group also demonstrated statistical significance in lossof hepatitis C virus.
The other presentation elaborated on interim data presented last fallby Guido Rasi and others at the University of Rome Tor Vergata.The 15-patient open-label study included 11 people who had failedprevious interferon therapy.
Nine of the 15 patients, including six interferon failures, losthepatitis B viral DNA and had normalized ALT levels. Seven of thenine responders seroconverted to hepatitis B e antigen negativestatus, and six of the nine became hepatitis B surface antigennegative.
"If these results are confirmed in future trials, thymosin alpha 1 willbecome a major drug for treating hepatitis," David Horwitz,SciClone's vice president of medical affairs, said in a preparedstatement.
Moore said the combination therapy's potential to clear the diseaseas well as lessen the side-effect profile is significant from a patient'sstandpoint. He said SciClone will wait until further results are infrom Alpha I Biomedical Inc.'s U.S. Phase III trial, which failed toshow statistical significance, before finalizing its U.S. clinicalstrategy. (SciClone subsequently acquired rights to the drug foralmost all of the world.) Moore said final analyses from that trialshould be complete early in 1995.
Partly because of the U.S. trial results, SciClone is delaying launchof the product in Singapore until results are in from a ongoing trial inTaiwan, which is not double-blinded.
"We want to make sure the physicians are comfortable with theresults in Taiwan," he said, adding that it would not make senseanyway to launch the product in December or early January, whenmany physicians and others are celebrating holidays.
Moore said an important distinction in the U.S. trial and the ones inSingapore and Taiwan is the treatment and follow-up periods _ 12months in the U.S. vs. 18 months in the others.
The Taiwan trial is designed to enroll 150 patients. Already 158 havebeen enrolled, Moore said, adding that results are in from 18patients. "The trends are positive," he said, "and we're encouragedby the results."
SciClone (NASDAQ:SCLN) stock was up 31 cents Thursday, toclose at $6.44 per share. n
-- Jim Shrine
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