06 Apr 2009 05:00 AM
First Patient Treated In Osiris Phase II Stem Cell Trial For Heart Attacks
Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced the treatment of the first patient in a Phase II clinical trial evaluating Prochymal for the treatment of heart attacks. The first patient, a 58-year old man, was treated at the Heart Hospital of Austin, Texas.
Prochymal is a proprietary formulation of adult stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation. The double-blind, placebo-controlled study is designed to enroll approximately 220 patients following their first heart attack.
"This landmark study is very exciting for the entire field of cardiology and we are honored to have enrolled and treated the first patient," said Roger Gammon, M.D., Medical Director of Research at Austin Heart. "The excellent safety profile and encouraging data from the Phase I trial makes Prochymal a promising therapy for the treatment of acute myocardial infarction. This trial will provide valuable data on the ability of these cells to prevent pathological remodeling, which is expected to have positive long-term implications for improved clinical outcomes in patients following a heart attack."
Recently, Osiris completed enrollment in a Phase III trial evaluating Prochymal for the treatment of steroid-refractory acute graft versus host disease (GvHD). In 2008, Osiris and Genzyme Corp. announced a strategic alliance for the development and commercialization of Prochymal. Under the terms of the agreement, Osiris will commercialize Prochymal in the United States and Canada, and Genzyme will commercialize the treatment in all other countries.
About the Phase II Acute Myocardial Infarction Trial
The Phase II double-blind, placebo-controlled trial will evaluate the safety and efficacy of Prochymal in conjunction with standard of care to improve heart function in patients who experienced a first heart attack. The trial will be conducted at leading institutions and academic research centers in the United States and Canada. This trial focuses on patients who have suffered a severe myocardial infarction. To be classified as severe, the patient's left ventricular ejection fraction, or LVEF, must be between 30% and 45% at baseline. LVEF, which reflects the fraction of blood pumped out of a ventricle with each heart beat, is a common measurement of overall heart function and typically declines after a heart attack…
Prochymal is a proprietary formulation of adult stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation. The double-blind, placebo-controlled study is designed to enroll approximately 220 patients following their first heart attack.
"This landmark study is very exciting for the entire field of cardiology and we are honored to have enrolled and treated the first patient," said Roger Gammon, M.D., Medical Director of Research at Austin Heart. "The excellent safety profile and encouraging data from the Phase I trial makes Prochymal a promising therapy for the treatment of acute myocardial infarction. This trial will provide valuable data on the ability of these cells to prevent pathological remodeling, which is expected to have positive long-term implications for improved clinical outcomes in patients following a heart attack."
Recently, Osiris completed enrollment in a Phase III trial evaluating Prochymal for the treatment of steroid-refractory acute graft versus host disease (GvHD). In 2008, Osiris and Genzyme Corp. announced a strategic alliance for the development and commercialization of Prochymal. Under the terms of the agreement, Osiris will commercialize Prochymal in the United States and Canada, and Genzyme will commercialize the treatment in all other countries.
About the Phase II Acute Myocardial Infarction Trial
The Phase II double-blind, placebo-controlled trial will evaluate the safety and efficacy of Prochymal in conjunction with standard of care to improve heart function in patients who experienced a first heart attack. The trial will be conducted at leading institutions and academic research centers in the United States and Canada. This trial focuses on patients who have suffered a severe myocardial infarction. To be classified as severe, the patient's left ventricular ejection fraction, or LVEF, must be between 30% and 45% at baseline. LVEF, which reflects the fraction of blood pumped out of a ventricle with each heart beat, is a common measurement of overall heart function and typically declines after a heart attack…
