Graft vs host disease, or GVHD, is a life threatening immunological reaction that occurs in certain patients who have received a bone marrow transplant. There are no approved treatments for GVHD.
Endpoints of the phase II study include response of GVHD to treatment with Prochymal, survival, and the safety and tolerability of the drug.
The study found that patients were twice as likely to have total clinical resolution of their disease when Prochymal was added to steroid therapy, compared to reported results for steroids alone. Furthermore, patients experiencing this complete response had a survival rate of over 90% at day 120.
“In this trial, approximately twice the number of patients achieved a complete response when given Prochymal as we would expect with steroids alone,” said Hans Klingemann, director, Bone Marrow and Hematopoietic Cell Transplant Program, Tufts New England Medical Center. “But what is most important is that this improvement in response carried over into high survival rates.”
“We were pleased to see that we could achieve higher complete response rates with Prochymal, without the mortality that often arises as a result of more aggressive immunosuppression,” said Rod Monroy, senior director for Prochymal.