SciClone Pharmaceuticals announced Tuesday that it has beguna multicenter Phase III trial in Mexico with 100 patients toevaluate thymosin alpha 1 in the treatment of hepatitis B.

Phillip Vander Werf, president and chief operating officer ofthe San Mateo, Calif., company, told BioWorld that SciClone hasalso begun enrolling patients for a planned 150-patient PhaseIII trial in Taiwan. "We're expecting to be on the market in1994 in Mexico and Taiwan," said Vander Werf.

Thymosin has shown effectiveness in halting the progression of"chronic active" hepatitis B, an advanced stage of illnessbrought on by the virus that can result in liver damage andlead to liver cancer. The drug has no significant side effects,according to Vander Werf.

Alpha interferon, currently used to treat chronic hepatitis B, isthymosin's only competitor on the market, but it produces flu-like symptoms and neurological disorders in a significantnumber of patients.

Liver disease specialist David Kershenobich of Mexico City'sInstituto Nacional de la Nutricion will coordinate the Phase IIItrial that is scheduled to begin at three major Mexicanhospitals. The trials will later be expanded to medical schoolhospitals in five other Latin American countries.

Vander Werf would not disclose any details on the Taiwanstudy.

SciClone licensed the chemically synthesized product, which ismolecularly identical to the natural thymosin peptide, fromAlpha One Biomedical Inc. (NASDAQ:ALBM) of Bethesda, Md.Alpha One will receive undisclosed royalty payments fromSciClone and will provide bulk product. SciClone holdsworldwide marketing rights to the compound for all countriesexcept the U.S., Europe, Canada, Israel and Korea. The companysaid its marketing rights cover countries that encompass 90percent of the world's hepatitis B-infected population.

Alpha One is currently conducting Phase III trials in the U.S.with thymosin for treatment of chronic hepatitis B. But VanderWerf said that since the incidence of hepatitis B in LatinAmerica and Asia is higher than in the U.S., patient accrual inSciClone's two trials may go more quickly.

Current estimates for the number of people infected with thehepatitis B virus in Mexico, South and Central Americacombined are 6.5 million. In the U.S., about 1.2 million peopleare infected. Vander Werf said that 700,000 people in Taiwanhave "chronic active" hepatitis B, while roughly 3 million areinfected.

"We're in very sensitive negotiations with a number of majorpharmaceutical companies and some local companies todevelop the agent in Japan, which could ultimately be ourbiggest market," added Vander Werf. SciClone plans to charge"at least as much" for thymosin as the $4,000-5,000 pertreatment price tag on alpha interferon.

SciClone's stock (NASDQA:SCLN) was up 50 cents a share onTuesday, closing at $18.25.

-- Lisa Piercey Business Editor

(c) 1997 American Health Consultants. All rights reserved.