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Stem Cell Drug Fails Trials
What might be the first drug derived from human stem cells has failed two late-stage trials. The failures come as a huge setback to Osiris Therapeutics, the developer of the drug.
The drug, known as Prochymal, was no more effective than a placebo in the treatment of life-threatening complications that can arise from bone marrow transplants. Prochymal is a drug that is a preparation of mesenchymal stem cells.
According to the New York Times, C. Randal Mills, Osiris Therapeutics' chief executive, hopes that the drug can be approved for those patients who suffer from bone marrow transplant complications.
Of the drug's success, Mills said in an interview that "Prochymal is having a clear effect in the liver, and that is the most underserved population."
Nevertheless, the FDA is still reluctant to give approval to Prochymal. Verdict is still out on what Orisis' next steps will be.
To read the full article, click here: http://www.nytimes.com/2009/09/09/health/research/09drug.html?scp=12&sq=September+9+2009&st=nyt


