COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ: OSIR), today announced that it has successfully completed enrollment in a Phase 2 clinical trial evaluating Prochymal (remestemcel-L), an adult mesenchymal stem cell therapy, in patients experiencing their first heart attack. The double-blind, placebo-controlled trial enrolled a total of 220 patients from 33 leading clinical centers in the United States and Canada.
“We appreciate the participation of our outstanding team of clinicians and would like to offer our special thanks to the patients who are taking part in this exciting trial,” said Lode Debrabandere, Ph.D., Senior Vice President of Therapeutics at Osiris. “We look forward to following their progress and collecting high quality data on the safety and efficacy of Prochymal in this significant indication.”
In 2009, Osiris completed a Phase 1 double-blind, placebo-controlled study in 53 patients that demonstrated the safety of Prochymal in cardiac patients suffering from their first heart attack. Additionally, treatment with Prochymal significantly improved cardiac function, patient global assessment and reduced cardiac arrhythmias (irregular heartbeat) when compared to placebo.
About the Phase 2 Acute Myocardial Infarction Trial
The Phase 2 double-blind, placebo-controlled trial will evaluate the safety and efficacy of Prochymal in conjunction with standard of care in improving heart function in patients who experienced their first heart attack. The trial is being conducted at leading institutions and academic research centers in the United States and Canada. The focus is on patients who have suffered a severe myocardial infarction. To be classified as severe, the patient’s left ventricular ejection fraction, or LVEF, must have been between 20% 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. Patients were randomized to either Prochymal or placebo at 1:1. Efficacy endpoints determined from cardiac MRI include end systolic volume, LVEF and the ability of Prochymal to preserve functional heart tissue and limit scar formation following a heart attack. In addition, functional and quality of life assessments will be performed.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading stem cell company focused on developing products to treat serious medical conditions in the inflammatory, autoimmune, orthopedic and cardiovascular areas. The company's pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee. Osiris is a fully integrated company, with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 47 U.S. and over 300 foreign patents. Osiris and Prochymal are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, www.Osiris.com. (OSIR-G)
Osiris and Genzyme formed a strategic alliance for the development and commercialization of Prochymal and Chondrogen. Under the terms of the agreement, Osiris retains commercialization rights to Prochymal and Chondrogen in the United States and Canada. Genzyme holds these rights in all other countries except Japan, where JCR Pharmaceuticals holds rights to Prochymal for the treatment of patients with hematological malignancies.
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as "anticipate," "believe," "continue," "ongoing," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project" or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements include, but are not limited to, statements regarding the following: our product development efforts; our clinical trials and anticipated regulatory requirements and the ability to successfully navigate these requirements; the success of our product candidates in development; status of the regulatory process for our biologic drug candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for Prochymal, Chondrogen and our other MSC and biologic drug candidates; our cash needs; patents and proprietary rights; the safety and ability of our potential products to treat disease and the results of our scientific research; our plans for sales and marketing; our plans regarding our facilities; types of regulatory frameworks we expect will be applicable to our potential products; and results of our scientific research. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Risks and uncertainties related to our Collaboration Agreement with Genzyme for the development and commercialization of Prochymal and Chondrogen include, among others: typical business transactional risks; risks related to product development and clinical trial design, performance and completion; uncertainty of the success of Prochymal and Chondrogen in clinical trials and their ability to treat disease; Genzyme’s early termination and opt-out rights; the ability of Osiris and Genzyme to successfully navigate regulatory requirements and to manufacture and commercialize products; and the uncertainty as to our ability to successfully perform under the collaborative arrangement and earn milestone and royalty payments thereunder. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled "Risk Factors" in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.