SangStat Starts Ph III Thymoglobulin Study
Transplantation specialist SangStat has started a pivotal Phase III study of its Thymoglobulin (rabbit anti-thymocyte globulin) product for the treatment of acute organ rejection in transplantation patients. Licensed from Pasteur Merieux Serums et Vaccins, a subsidiary of Rhone-Poulenc, this polyclonal antibody is a market leader in Europe and has been sold since 1985.
An Investigational New Drug application for the single, pivotal Phase III study was filed with the US Food and Drug Administration on June 15 and approved July 21, said SangStat. Patients in the study will receive either Thymoglobulin or currently-available antilymphocyte globulin therapy for graft rejection episodes and will be followed for a period of three months to monitor primary and secondary outcome endpoints.
SangStat acquired the exclusive rights to develop and market the drug in the USA and Canada in October 1993. PMSV will continue to manufacture Thymoglobulin for SangStat and will market it outside North America.
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