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news.Kiadis Pharma has said that its lead product, ATIR, has been granted orphan drug designation by the FDA as a therapy for immune reconstitution and prevention of graft versus host disease, following allogeneic bone marrow transplantation.
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ATIR is under development to prevent life-threatening graft versus host disease (GvHD), a major complication of allogeneic bone marrow transplantations. By preventing the occurrence of GvHD, ATIR enables the use of a mismatched donor and consequently addresses a significant limitation in bone marrow transplantation: the timely availability of a donor.
ATIR is currently in Phase I/II clinical studies and anticipated to enter clinical Phase III studies in 2008.
Manja Bouman, CEO of Kiadis Pharma, said: “This is an important strategic milestone in the development of ATIR as a novel approach which may enable a safe and potentially life-saving mismatched bone marrow transplantation as a treatment option for end-stage blood cancer patients.”