SangStat Medical Corporation announced that the US Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications for clinical studies of its leading marketed product, Thymoglobulin (anti-Thymocyte-globulin, rabbit).
These INDs permit SangStat to proceed with studies of Thymoglobulin as a conditioning treatment in Blood and Marrow Transplantation (BMT, commonly called Bone Marrow Transplantation) and as induction therapy for living donor kidney transplant patients. In the US, Thymoglobulin is currently indicated for the treatment of renal transplant acute rejection, in conjunction with concomitant immunosuppression.
"Studying Thymoglobulin in both BMT and living donor kidney transplant induction therapy is an important step in providing clinicians with answers to the questions they are asking," said Richard D. Murdock, Chairman, President and CEO at SangStat. "These therapeutic categories are important because they represent potential new clinical applications for Thymoglobulin."
Living donor kidney transplants are the fastest growing type of solid organ transplant in the US and accounted for nearly 45 percent, or approximately 6,500, of all US kidney transplants in 2002. Traditionally in solid organ transplantation, patients receive a triple combination of lifelong immunosuppression including corticosteroids (CS) and two additional therapies. Preliminary clinical studies have recently suggested that induction therapy with an appropriate antibody may dramatically reduce or eliminate the need for use of chronic steroids in these patients.