Prochymal: Additional Phase III data

Additional data from a double-blind, international Phase III trial showed that IV Prochymal twice weekly for 4 weeks significantly improved overall response rate vs. placebo in a subgroup of 22 patients with GvHD affecting the skin, liver and gastrointestinal tract at day 28 (63% vs. 0%, p<0.05). Prochymal showed a safety profile similar to placebo, including incidence of recurrent malignancy (8% vs. 10%), infusional toxicity (2% for both) and discontinuation due to adverse events (1% vs. 5%).

Additionally, in a subset of 28 pediatric patients, Prochymal resulted in an overall response rate of 64% vs. 36% for placebo, a complete response rate of 64% vs. 29% for placebo, and a disease progression rate of 21% vs. 43% for placebo. Prochymal also increased 100 day survival vs. placebo (79% vs. 50%). There were no cases of infusion toxicity or ectopic tissue reported and no adverse events leading to discontinuation of therapy in the pediatric subgroup. Data were presented at the Center for International Blood and Marrow Transplant Research and the American Society of Blood and Marrow Transplantation tandem meeting in Orlando. ...