Prochymal currently is in Phase III clinical trials for the treatment of GvHD and Crohn’s Disease and has demonstrated preliminary efficacy in the treatment of patients experiencing first-time heart attacks. These trials have shown Prochymal’s potential to reverse cellular damage and improve survival in disease states similar to ARS.
"After an extensive evaluation of the indication, product and process, we are properly positioned to launch this major new initiative," said C. Randal Mills, Ph.D., president and CEO of Osiris. “Our scientists recognized an opportunity to efficiently enter this new market by leveraging the significant overlap that exists between our ongoing development activities for Prochymal and the requirements demanded of an ARS product. We then assembled a team that would give us the greatest chance for success. The resources and capabilities of Genzyme fit very well with this initiative.”
Currently, Prochymal is the only stem cell therapy to have been granted Fast Track status by FDA.
“Based upon the clinical data generated by Osiris, coupled with our own internal research, we believe there is potential for Prochymal to be of significant therapeutic benefit to patients suffering the effects of ARS,” said John M. McPherson, senior vice president and head of biologics research and development, Genzyme Corp.
More information about Prochymal and its development for ARS can be found on the Osiris Web site at http://www.Osiris.com.