Mental HealthOsiris Therapeutics Reports Interim Data For COPD Stem Cell Study
Therapeutics, Inc. (NASDAQ:OSIR) announced six-month interim data from a Phase II clinical trial evaluating Prochymal, the Company"s proprietary formulation of adult mesenchymal stem cells, for the treatment of chronic obstructive pulmonary disease (COPD). Sixty-two patients were enrolled and are being followed for two years in the placebo-controlled study. At the six-month time-point, the data revealed several important findings.
Important Findings:
- 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."
Six-Month Interim Data
Prochymal was evaluated in a total of 62 patients, 58% of them male. The patients ranged in age from 47 to 80 years and suffered from moderate (n=23) to severe (n=39) COPD. Patients had been suffering with COPD for an average of 7.8 years. Patients with asthma were excluded from the trial.
All patients in the trial completed the planned course of four infusions without any evidence of infusional toxicity. Oxygen saturation levels were measured throughout each infusion and showed no adverse effects of the infusion. Adverse event rates were comparable for patients receiving Prochymal and placebo. There were no signs of adverse immune reaction after any of the four infusions and no differences in the reported incidence of infection of any kind.
Prochymal significantly decreased the levels of CRP compared to placebo in those patients with elevated CRP (>4 mg/L) at the time of study entry (pAbout the Phase II Chronic Obstructive Pulmonary Disease Trial
The Phase II trial is evaluating the safety of Prochymal in conjunction with standard of care in patients with moderate to severe COPD. The clinical trial is a double-blind, placebo-controlled study. A total of 62 patients were randomized to either Prochymal or placebo at a 1:1 ratio. In order to explore potential improvements in pulmonary function, several evaluations including pulmonary function tests, exercise capability, and quality of life assessments are being conducted. In addition, exacerbations and hospitalizations due to COPD will be monitored for both safety and efficacy. Patients will be evaluated over the course of two years following initial Prochymal or placebo infusion.
About Prochymal
Prochymal is a preparation of mesenchymal stem cells specially formulated for intravenous infusion. The stem cells are obtained from the bone marrow of healthy adult donors, avoiding the controversy surrounding embryonic and fetal cell s. Prochymal is currently being evaluated in three, double-blind, placebo-controlled Phase III studies, including steroid refractory GvHD, acute GvHD, and Crohn"s disease. Prochymal has been granted Fast Track status by FDA for all three of these indications. Prochymal also obtained Orphan Drug status by FDA and the European Medicines Agency for GvHD. Prochymal is also being studied in Phase II trials for the treatment of acute myocardial infarction and type 1 diabetes. Additionally, the Department of Defense awarded Osiris a contract to develop Prochymal as a treatment for acute radiation syndrome.
Osiris Therapeutics