SangStat Medical Corp. has begun Phase III trials of Thymoglobulin, adrug currently on the market in Belgium and France, for treatment ofacute kidney rejection in transplant patients.SangStat, of Menlo Park, Calif., has North American marketing rightsfor Thymoglobulin, which was developed by Pasteur Merrieux Serumset Vaccins, a subsidiary of the France-based Rhone Poulenc Group.Thymoglobulin, a polyclonal antibody, is a rabbit anti-thymocyteglobulin therapy that destroys T cells, which are generated by the organrecipients and cause rejection of donor kidneys. The polyclonalantibodies are derived from rabbits injected with human thymus cells.Maria Straatmann, SangStat's director of investor relations, said thetrials will involve 200 kidney transplant patients at 12 to 14 centers inthe U.S. The first three trial sites are University of Cincinnati,University of Tennessee at Memphis and Virginia Medical College.The studies, expected to take a year, will attempt to determine if thedrug reverses organ rejection. They also will compareThymoglobulin's effectiveness to the Michigan-based Upjohn Co.'sApgam, an anti-lymphocyte globulin therapy approved by the FDA forkidney transplant rejection. Half the patients will receiveThymoglobulin and the other half will receive Apgam in therandomized, double-blind studies.The Phase III trials are the first in the U.S. and are based on the drug'sperformance in other markets. Straatmann said most Thymoglobulinsales are in Belgium and France, but it has been registered in 25countries and has been used to treat 25,000 patients. The drug has beensold in France since 1985.Under an October 1993 agreement, SangStat has exclusive marketingrights in Canada and the U.S. for Thymoglobulin and Pasteur Merieuxhas manufacturing rights. Pasteur Merieux has marketing rights outsideNorth America.SangStat's stock (NASDAQ:SANG) closed Monday at $5.50 a share,down 25 cents. _ Charles Craig
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