This excerpt taken from the OSIR 8-K filed Jun 25, 2009.
· The trial met its primary goal of demonstrating the safety of Prochymal in patients with compromised pulmonary function at the six-month evaluation point.
· Prochymal significantly decreased systemic inflammation in patients when compared to those receiving placebo, as determined by C-reactive protein (CRP).
· Despite the reduction in inflammation, pulmonary function in patients receiving Prochymal was not significantly improved compared to those receiving placebo.
We are very pleased with the interim outcome of this study and that the data continues to support the strong safety profile of this therapy, particularly given the severity of these patients pulmonary disease, said C. Randal Mills, Ph.D., President and CEO of Osiris Therapeutics. Importantly, we are gratified to obtain clear, objective data that helps bolster our understanding of the anti-inflammatory effects of these remarkable cells. Short-term, these anti-inflammatory effects did not appear to improve pulmonary function in patients with advanced destructive changes of the lung. Collectively however, these findings add to our confidence about the safety and effectiveness of the drug.