Gazette.Net: Osiris scores approval down under for stem cell drug

Osiris Therapeutics has won a second nations imprimatur for its stem cell treatment for a deadly complication of bone marrow transplants in children.

Following Canada's lead last month, New Zealand this week gave the Columbia company marketing approval for Prochymal to treat pediatric graft-vs.-host disease, Osiris reported. Canada was the first internationally recognized regulatory body to approve a stem cell drug.

The disease kills up to 80 percent of children who contract it, many within weeks of diagnosis.

"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role, CEO C. Randal Mills said in a company statement.

More cases of the disease are expected "as the demographic profile of our transplant population evolves," Hans Klingemann, professor of medicine and director of the Bone Marrow & Hematopoietic Stem Cell Transplant Program at Tufts University School of Medicine, said in the statement. "Effective strategies to manage the often lethal consequences of [graft-vs.-host disease] reduce the overall risk to transplantation ..."

Osiris applied for marketing approval in New Zealand in May 2011 and was given priority review the following month.

Besides Canada and New Zealand, Prochymal is available in the U.S. and several other nations under special patient circumstances.

The company also is testing the drug as a treatment for Crohns disease, heart attacks and type 1 diabetes.

In other Maryland bioscience industry news:

Sanaria, working with University of Maryland researchers, has won a three-year federal grant worth almost $3 million to genetically engineer mosquitoes for the Rockville biotech's malaria vaccine manufacturing program.

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Gazette.Net: Osiris scores approval down under for stem cell drug

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