Could gap up on monday.
Osiris Therapeutics Announces Positive Results in Groundbreaking Stem Cell Trial to Treat Heart Disease
3/25/2007
Intravenous Therapy Resulted in Statistically Significant
Improvement Over Placebo in Multiple Safety and Efficacy Endpoints
BALTIMORE, Mar 25, 2007 (BUSINESS WIRE) --
Osiris Therapeutics, Inc. (Nasdaq:OSIR) today announces positive six-month results in a groundbreaking clinical trial evaluating PROVACEL(TM), an adult mesenchymal stem cell (MSC) therapy for the treatment of heart disease.
In a 53-patient, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of the intravenous administration of PROVACEL, heart attack patients receiving the therapy had significantly lower rates of adverse events, such as cardiac arrhythmias, as well as significant improvements in heart, lung and overall condition. Joshua Hare M.D., the trial's lead investigator, presented the data this morning at the American College of Cardiology's Innovation in Intervention: i2 Summit.
"We are extremely enthusiastic and encouraged by the degree to which these results indicate that MSCs are not only safe, but also appear to clinically improve patients who have suffered a heart attack," said Dr. Hare, who is the Lemberg Professor of Medicine at the Miller School of Medicine, University of Miami; Chief of the Cardiology Division; and Director of the School's Interdisciplinary Stem Cell Institute. "The results consistently show patient improvement with regard to heart and lung function, and indicate global improvements in well-being. These findings strongly support the ongoing development of PROVACEL for acute myocardial infarction and possibly other forms of heart and lung disease."
C. Randal Mills Ph.D., President and CEO of Osiris Therapeutics, said: "We were confident in the safety profile given our previous experience using the intravenous form of these stem cells to treat other diseases in later stage clinical trials. However, the magnitude of the across-the-board improvement was surprising. These data further validate the broad clinical applicability of our stem cell technology. Based on these encouraging results, we have started working on the design of the next stage of clinical trials."
Trial Highlights
-- Administration of PROVACEL was found to be well tolerated at all dose levels.
-- Patients in the PROVACEL group were four times less likely to experience an arrhythmic event compared to those receiving placebo (9% vs. 37%, p=0.025).
-- Fewer patients experienced clinically significant premature ventricular contractions after receiving PROVACEL as compared to placebo across all time points (11% vs. 24%, p less than 0.001).
-- PROVACEL patients with major "anterior wall" heart attacks had a statistically significant 7.0 point (24%) improvement in ejection fraction at three months and a 7.3 point (25%) improvement at six months over baseline (p less than 0.05), while similar patients receiving placebo did not have significant improvement.
-- Patients receiving PROVACEL had significantly improved lung function as measured by improvement in FEV1 % predicted values (17 point PROVACEL vs. 6 point placebo, p less than 0.05).
-- Significantly more patients who received PROVACEL experienced improvement in their overall condition at six months as compared to those receiving placebo (42% vs. 11%, p=0.027).
"The data speak for themselves," said Timothy Henry M.D., Director of Research at the Minneapolis Heart Institute Foundation at Abbott Northwestern. "This was a carefully executed, double-blind, placebo-controlled trial where patients who received the stem cells simply did better. The results are fascinating, particularly given the route of administration, and lead us to challenge our basic assumptions about cell therapy for heart disease."
