The U.S. Food and Drug Administration has granted orphan drug status to Kiadis Pharma for its lead drug ATIR.
ATIR is currently in Phase I/II clinical studies as a therapy for immune reconstitution and prevention of Graft vs Host Disease (GvHD) following allogenic bone marrow transplantation. The drug is expected to go into Phase III trials in 2008.
"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" said Dr. Manja Bouman, Chief Executive Officer of Kiadis Pharma.
GvHD is one of the biggest concerns during any bone marrow transplant. It is a condition where the donor's immune cells and attack the tissues and organs of the recipient. Allogenic bone marrow transplants require that patient and donor are highly similar to have the greatest chance to avoid GvHD. If ATIR lives up to expectations of preventing the occurrence in GvHD it will allow for mismatched donors and significantly increase the pool of marrow donors.
ATIR is designed to selectively eliminate the immune cells that would attack the patient's body and spare useful immune cells that fight infections and remaining tumor cells.
[Source: PRNewsWire]
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