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Osiris Demonstrates Exceptional Performance of Adult Stem Cell Product in Clinical Trial

FierceBiotech.com, February 12, 2009

The company Osiris Therapeutics, which is focused exclusively on the development of adult stem cell therapies, not embryonic stem cell therapies, today reported the final data from its two-year-long Phase I clinical trial in which one of its adult stem cell products, Prochymal, was evaluated for safety and preliminary efficacy in the treatment of heart attack. The double-blind, placebo-controlled study consisted of 53 participants who had suffered acute myocardial infarction (MI), all of whom were fully immunocompetent patients, and none of whom exhibited any signs of adverse immune response or infusional toxicities from the Prochymal. In fact, Prochymal demonstrated even greater safety than a placebo, since the patients who received the placebo instead of Prochymal exhibited a higher rate of adverse events. For the patients who received Prochymal instead of a placebo, Prochymal resulted in the improvement of a number of parameters including a drop in repeat hospitalizations as well as significant improvement in cardiac function and reduced incidents of cardiac arrhythmia. Not only did the clinical trial met its primary endpoint for demonstrating the safety of Prochymal in an acute MI setting, but in all aspects Prochymal has exhibited an extremely favorable safety profile. Additionally, experts describe the procedure as being so simple that even community hospitals could easily adopt the protocol.

Data from this ground-breaking adult stem cell therapeutic product indicate that Prochymal does indeed expedite patient recovery from heart trauma, which previously has always been extremely difficult to treat with much success. According to the president and CEO of Osiris Therapeutics, Dr. C. Randall Mills, "This study adds convincing long-term data to the excellent safety profile of Prochymal, having now treated hundreds of patients in trials over the past decade. We are excited that Prochymal demonstrated strong evidence of efficacy beyond the best cardiac care available today. We are now advancing this program into a larger Phase II trial, focusing on patients with more severe heart damage."

Osiris is developing its Prochymal therapy in collaboration with Genzyme, with whom Osiris formed a strategic alliance last year for the development and commercialization of Prochymal, and for which enrollment was recently completed in a Phase III clinical trial for the treatment of steroid-refractory acute graft-versus-host disease. Additionally, in January Osiris received FDA approval to broaden its expanded access program for Prochymal, which is a proprietary preparation of mesenchymal stem cells that are derived from the bone marrow of healthy adult donors and specifically formulated for intravenous infusion.

According to Dr. Timothy Henry, director of research at the Minneapolis Heart Institue Foundation at Abbott Northwestern, "This placebo-controlled study was truly the first of its kind and the data produced are promising. It clearly suggests that allogeneic adult stem cells have significant potential to improve recovery following a heart attack and can prevent long-term adverse effects. Given the fact that we can administer this drug through a standard I.V. in an acute setting, Prochymal could become an integral part of standard-of-care for the treatment of heart attacks everywhere."

Osiris is focused on the treatment of a variety of inflammatory, orthopedic and cardiovascular diseases. As described on their website, "Prochymal is currently being evaluated in Phase III trials for steroid refractory GvHD, acute GvHD, and Crohn's disease. Prochymal has been granted Fast Track status by the FDA for all three of these indications. Prochymal also obtained Orphan Drug status by the FDA and the European Medicines Agency for GvHD. Prochymal is being studied in Phase II trials for the treatment of COPD (chronic obstructive pulmonary disease), type 1 diabetes, and acute myocardial infarction. Additionally, the U.S. Depaartment of Defense recently awarded Osiris a contract to develop Prochymal as a treatment for acute radiation syndrome."

Osiris Therapeutics is the leading stem cell therapeutic company in the world, involved in the research and development of therapeutic products that are based exclusively upon adult stem cells, not embryonic stem cells.



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