A Columbia-based biotechnology company said this week it received the worlds first government approval to market a stem cell drug, in Canada.

Osiris Therapeutics, founded in 1992, spent 17 years developing a stem cell therapy that offers anti-inflammatory and tissue-regeneration properties. The first treatment it has received approval for this week will help treat children whove received bone marrow transplants that their bodies have rejected. The condition, known as acute graft-versus-host disease, or GvHD, is fatal to 80 percent of the children who contract it, the company said.

C. Randal Mills, president and CEO of Osiris, said in a conference call Friday morning that the company has spent the past eight years navigating clinical trials and regulatory paperwork in a mission to be the first approved stem cell treatment in the world.

During the past eight years, we have not wavered from that mission, Mills said. We now need a new mission.

The two-decade path to market for Osiris drug, Prochymal, is par for the course in the biotechnology industry, where a new pharmaceutical is measured in multi-million dollar clinical trials and reviews that take years.

Prochymal is the first off-the-shelf stem cell drug approved for sale, and the first approved for GvHD, the company said. It derives its stem cells, it said, from the bone marrow of healthy adult donors between 18 and 30 years old.

Osiris is a small biotech company, with around 50 employees, in an industry where far larger competitors, with thousands of employees, usually grab the headlines with blockbuster drugs.

Yet Osiris is a key player in the states nascent stem cell therapies industry. Osiris is one of the worlds largest and most advanced stem cell firms, according to testimony provided by the leaders of the Maryland Stem Cell Research Fund this year in the General Assembly.

The taxpayer-subsidized fund doles out millions of dollars a year in grants to promote stem cell research; Osiris, however, has never received a grant from the fund, according to TEDCO.

This week, the fund said it will award $12.4 million in research grants to 40 projects led by university researchers from Johns Hopkins, University of Maryland and other institutions.

Original post:
Columbia firm is world's first to market with stem cell drug

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