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Posted by: Mike Havrilla in Untagged on Apr 17, 2009
On 4/17/09, OSIR announced that it has successfully completed patient enrollment in its pivotal, Phase III trial evaluating Prochymal as a first-line treatment for acute graft vs. host disease (GvHD), a life-threatening complication of bone-marrow transplantation. Prochymal Phase 3 Results for graft-vs-host disease (GvHD) Expected 2H09 for both trials.
The double-blind, placebo-controlled trial enrolled 190 patients from 52 leading transplant centers across the United States, Canada and Australia. Osiris has now completed enrollment in two pivotal stem cell trials in GvHD and expects top-line data from both studies in the second half of 2009.
Additionally, the company announced that it has confirmed with the U.S. Food and Drug Administration, receipt of the first portions of its Biological License Application or BLA for Prochymal as part of a rolling submission. Rolling submission is an FDA provision available to drug candidates that have received Fast Track designation, which allows for completed sections of a BLA to be submitted on an ongoing basis.