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Osiris Therapeutics Management Discusses Q2 2012 Results - Earnings Call Transcript

For those of you who are not familiar with acute GvHD, it is a devastating disease that kills up to 80% of the children affected. It is a complication of bone marrow transplantation, and when T cells in the graft attack the host, its victims endure blistering of the skin, intestinal hemorrhage and liver failure. This makes GvHD the leading cost of transplant-related mortality with a median survival of only 80 days. Generally, steroids are used as a first line of therapy with a success rate of about 50%. When steroids fail, treatment options are limited.

It is in this setting where Prochymal can save lives. With Prochymal, we have been able to rescue 63% of children and significantly improve their chances of survival. To date, our initial meetings regarding reimbursement have been positive, but we have a few more to go. At this time, we anticipate Prochymal to be commercially available with reimbursement in Canada later this year.

Outside of Canada and New Zealand, we continue to work with regulatory agencies around the world to provide GvHD patients in those territories with access to our first-in-class off-the-shelf stem cell drug. We are working diligently to provide each agency with the information they need to approve Prochymal.

In addition to GvHD, Prochymal is also in development for Crohn's disease, acute myocardial infarction and type 1 diabetes. We continue to enroll patients in our Phase III clinical trial evaluating Prochymal in patients with moderate to severe treatment-resistant Crohn's disease. We've expanded the number of countries and clinical sites with approximately 20 leading centers to enroll up to 330 patients. This double-blind placebo-controlled trial is evaluating Prochymal's ability to induce remission in a patient population refractory to steroids and biologics for which there is clearly an unmet medical need.

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