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Stem cell drug first for Osiris

US firm's Prochymal approved in Canada to treat bone marrow transplant complication

Canadian regulators have approved a stem cell treatment for acute graft vs host disease (GvHD), a potentially fatal complication of bone marrow transplants.

Osiris Therapeutics said Health Canada's decision makes Prochymal (remestemcel-l) the first stem cell drug in the world to win regulatory approval and marks the culmination of 20 years' of research.

Prochymal was approved with several post-marketing conditions, as part of which Osiris must carry out additional clinical trials to prove the treatment's clinical benefit.

Health Canada also wants the US stem cell company to “encourage” all patients that receive the drug to participate in a registry that will monitor the therapy's long-term effects. 

The company is still seeking approval for the drug in the US, where the Food and Drug Administration (FDA) has yet to make a decision on the drug after last year requesting more information on it from Osiris.

In Canada, Prochymal was approved as a treatment for the management of acute GvHD in children who fail to respond to steroids after clinical trials showed a clinically meaningful response after 28 days of therapy in up to 64 per cent of patients.

Osiris' CEO and president C. Randal Mills said: “Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies.

“Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.”

GvHD is the leading cause of bone marrow transplant-related mortality and occurs when immune cells within the transplanted marrow identify the recipient as foreign and mount an immunologic attack.

Prochymal is an intravenous formulation of mesenchymal stem cells (MSCs), which are derived from the bone marrow of healthy adult donors aged 18 to 30. The MSCs are grown in culture so that up to 10,000 doses of Prochymal can be produced, and frozen for later use, from a single donor.

The treatment is currently in phase III trials for refractory Crohn's disease and phase II trials in myocardial infarction (heart attack) and type 1 diabetes.

Following Health Canada's deicision to green light Prochymal's use in GvHD, Osiris said it would launch the drug in Canada later this year.

18th May 2012

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