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Osiris Therapeutics, Inc. Message Board

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  • djuengst2000 djuengst2000 Aug 23, 2012 9:55 PM Flag

    Uglier by the day!

    Prochymal failed in type I diabetes because the primary endpoint was reduction in C-reactive protein, a marker for inflammation. After this failure I looked into inflammation and type I diabetes and I thought the correlation was speculative at best. Still, that was how the trial was run and Prochymal failed. OSIR had been toting the anti-inflammation properties of Prochymal so this was a major set back. Primary of care for Crohn's disease nowadays are biologics like Remicade and Humira, which are anti-inflammatory. So one might conclude that Prochymal would fail in inflammatory related diseases. However, stem cells may have an unique mechanism of action that is not inflammatory in nature. The efficacy in GVHD can not be ignored. Even if you look at the trial data and say "well Prochrymal didn't meet all it's primary endpoints in GVHD", it met two of the three and was as good as standard of care in the third. C-reactive protein is not a primary endpoint in the Crohn's trial and certainly not in AMI.
    http://clinicaltrials.gov/ct2/show/NCT01233960?term=prochymal&rank=3
    http://clinicaltrials.gov/ct2/show/NCT00877903?term=prochymal&rank=7

 
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