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Osiris Therapeutics

(OSIR) - Get Osiris Therapeutics, Inc. Report

has received regulatory approval to conduct late-stage trials for its lead stem-cell drug in Canada.

The drug, known as Prochymal, is meant to treat a condition known as graft-vs.-host disease in which patients who receive transplants or donated bone marrow experience a life-threatening immune system reaction. No treatments are approved for the condition.

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The company's application to expand the trial into Canada was based on safety and efficacy data as well as quality specifications and patient information provided to the regulatory agency, Health Canada.

"This trial is a major undertaking with worldwide implications" Osiris said. "If successful, Prochymal may not only be the first treatment approved for GVHD, but also the first stem-cell drug approved for any indication."

The Food and Drug Administration has granted the drug fast-track status and an orphan-drug designation.