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Clinical Trial Update: Osiris receives second approval for GvHD-fighting stem cell drug

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Prochymal is an intravenous formulation of mesenchymal stem cells (MSCs) derived from the bone marrow of healthy adult donors. It is the first therapy approved for GvHD, a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within weeks of diagnosis. It is also the first approved drug with a stem cell as its active ingredient.

In clinical trials Prochymal induced a clinically meaningful response in more than 60 percent of children with GvHD that is otherwise resistant to treatment, the company reported. The drug also resulted in a statistically significant improvement in survival.

Prochymal is now approved in Canada and New Zealand and currently available in seven other countries, including the United States, under an Expanded Access Program (EAP). It is expected be commercially available in New Zealand later this year.

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