This is good news...because the stem cells they used for the heart also had better lung function. Sure lungs are coming soon !!!!
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Prochymal(TM) Demonstrates Lasting Benefit in Heart Attack Patients; Osiris Receives FDA Clearance to Start Phase II Trial One Year Results of Phase I Trial Continue to Demonstrate Safety and Persistent Cardiac Improvement COLUMBIA, Md.--(BUSINESS WIRE)--
Feb. 26, 2008--
OsirisTherapeutics, Inc. (NASDAQ:OSIR) today announced that interim resultsat the one year time point for the Company's Phase I trial evaluatingProchymal(TM) for the treatment of heart attack patients continued todemonstrate a strong safety profile and statistically significantimprovement in heart function. Based upon the positive results fromthis 53-patient, double-blind, placebo-controlled trial, the Companyhas received approval from the Food and Drug Administration (FDA) toinitiate a Phase II trial. "This early stage trial exceeded our expectations for both safetyand efficacy," said C. Randal Mills, Ph.D., President and ChiefExecutive Officer of Osiris. "These data support our pre-clinicalresults and suggest that in acute myocardial infarction, earlytreatment with Prochymal can alter the course of disease. Based onthis encouraging data, we look forward to promptly advancing Prochymalin this exciting, multi-billion dollar market." Prochymal for Heart Attack Patients: An Interim Analysis at OneYear The trial collected one-year magnetic resonance imaging (MRI) dataon left ventricular ejection fraction (LVEF), which reflects thefraction of blood pumped out of a ventricle with each heart beat. Thisis a commonly used measurement of overall heart function and typicallydeclines after injury to the heart, as often occurs in heart attackpatients. Patients with significantly compromised LVEF progress toheart failure. Key results include: -- The Prochymal treatment group achieved a statisticallysignificant 5.2 point increase in LVEF over baseline (P =0.021). The placebo group experienced a 1.8 point improvementin LVEF over baseline, which was not statisticallysignificant. -- Patients with more severe myocardial infarction, defined as abaseline LVEF of 45 or less, demonstrated even greatereffects. The Prochymal-treatment group showed a 6.5 pointimprovement one-year post-treatment, compared to a 1.9 pointincrease in the placebo group. -- Prochymal treated patients continued to experience feweradverse events, at a rate of 6.1 per patient, compared to 8.0per placebo-group patient. -- No serious adverse events were attributed to Prochymal. "First and foremost, the safety data generated in this trial wereoutstanding and add to the growing body of evidence demonstrating thatProchymal can be used to treat patients in the acute setting," saidJoshua Hare, M.D., lead investigator for the Prochymal cardiac study.Dr. Hare is the Louis Lemberg Professor of Medicine at the MillerSchool of Medicine, University of Miami; Chief of the CardiovascularDivision; and Director of the School's Interdisciplinary Stem CellInstitute. "The data further suggest that the greater the cardiacdamage, the greater the potential benefit from Prochymal. We are veryexcited about advancing Prochymal into Phase II, and the prospect ofushering in a new era in the treatment of myocardial infarction." The one year interim analysis was performed as part of the fulltwo year follow-up period to the trial, and as a result, contains onlylimited data. A more comprehensive data set will be available at thetwo year time-point, which marks the conclusion of the trial. Prochymal, a patented formulation of adult stem cells, iscurrently in Phase III clinical trials for the treatment of Graft vs.Host Disease and Crohn's Disease and is in a Phase II trial for type 1diabetes. Osiris was recently awarded a $224.7 million contract forthe development and stockpile of Prochymal by the Defense Departmentfor the treatment of acute radiation syndrome. The Company recentlyregained exclusive world-wide rights to cardiovascular indications forthe product and as a result, discontinued using the cardiac specificbrand name Provacel.
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Prochymal(TM) Demonstrates Lasting Benefit in Heart Attack Patients; Osiris Receives FDA Clearance to Start Phase II Trial One Year Results of Phase I Trial Continue to Demonstrate Safety and Persistent Cardiac Improvement COLUMBIA, Md.--(BUSINESS WIRE)--
Feb. 26, 2008--
OsirisTherapeutics, Inc. (NASDAQ:OSIR) today announced that interim resultsat the one year time point for the Company's Phase I trial evaluatingProchymal(TM) for the treatment of heart attack patients continued todemonstrate a strong safety profile and statistically significantimprovement in heart function. Based upon the positive results fromthis 53-patient, double-blind, placebo-controlled trial, the Companyhas received approval from the Food and Drug Administration (FDA) toinitiate a Phase II trial. "This early stage trial exceeded our expectations for both safetyand efficacy," said C. Randal Mills, Ph.D., President and ChiefExecutive Officer of Osiris. "These data support our pre-clinicalresults and suggest that in acute myocardial infarction, earlytreatment with Prochymal can alter the course of disease. Based onthis encouraging data, we look forward to promptly advancing Prochymalin this exciting, multi-billion dollar market." Prochymal for Heart Attack Patients: An Interim Analysis at OneYear The trial collected one-year magnetic resonance imaging (MRI) dataon left ventricular ejection fraction (LVEF), which reflects thefraction of blood pumped out of a ventricle with each heart beat. Thisis a commonly used measurement of overall heart function and typicallydeclines after injury to the heart, as often occurs in heart attackpatients. Patients with significantly compromised LVEF progress toheart failure. Key results include: -- The Prochymal treatment group achieved a statisticallysignificant 5.2 point increase in LVEF over baseline (P =0.021). The placebo group experienced a 1.8 point improvementin LVEF over baseline, which was not statisticallysignificant. -- Patients with more severe myocardial infarction, defined as abaseline LVEF of 45 or less, demonstrated even greatereffects. The Prochymal-treatment group showed a 6.5 pointimprovement one-year post-treatment, compared to a 1.9 pointincrease in the placebo group. -- Prochymal treated patients continued to experience feweradverse events, at a rate of 6.1 per patient, compared to 8.0per placebo-group patient. -- No serious adverse events were attributed to Prochymal. "First and foremost, the safety data generated in this trial wereoutstanding and add to the growing body of evidence demonstrating thatProchymal can be used to treat patients in the acute setting," saidJoshua Hare, M.D., lead investigator for the Prochymal cardiac study.Dr. Hare is the Louis Lemberg Professor of Medicine at the MillerSchool of Medicine, University of Miami; Chief of the CardiovascularDivision; and Director of the School's Interdisciplinary Stem CellInstitute. "The data further suggest that the greater the cardiacdamage, the greater the potential benefit from Prochymal. We are veryexcited about advancing Prochymal into Phase II, and the prospect ofushering in a new era in the treatment of myocardial infarction." The one year interim analysis was performed as part of the fulltwo year follow-up period to the trial, and as a result, contains onlylimited data. A more comprehensive data set will be available at thetwo year time-point, which marks the conclusion of the trial. Prochymal, a patented formulation of adult stem cells, iscurrently in Phase III clinical trials for the treatment of Graft vs.Host Disease and Crohn's Disease and is in a Phase II trial for type 1diabetes. Osiris was recently awarded a $224.7 million contract forthe development and stockpile of Prochymal by the Defense Departmentfor the treatment of acute radiation syndrome. The Company recentlyregained exclusive world-wide rights to cardiovascular indications forthe product and as a result, discontinued using the cardiac specificbrand name Provacel.