Gazette.Net: Biowatch: Osiris stem cell treatment shows promise for heart attacks

Patients in a clinical trial who received Osiris Therapeutics stem cell treatment within a week after experiencing their first heart attack showed "significantly less" damage and arrhythmia than those who received a placebo.

The interim one-year results are from a phase 2 trial of Prochymal involving 220 heart attack patients, ages 21 to 85.

"This study is the largest of its kind and provides key insights into the mechanism of action of mesenchymal stem cells in the setting of acute myocardial infarction," Lode Debrabandere, senior vice president of therapeutics at the Columbia company, said in a statement. "These important mechanistic observations are consistent with data obtained from our preclinical models and from the first placebo-controlled human trial with Prochymal published in the Journal of the American College of Cardiology. Given the quality of the data and highly encouraging results observed thus far, we are extending the trial's duration to capture a better understanding of the long-term clinical benefits ..."

Furthermore, the trial showed that the treatment is safe, with no toxicities seen in patients who received it. So far, there have been five deaths in the trial: two in the Prochymal group and three in the placebo group.

"For interventional cardiologists, keeping our myocardial infarction patients from progressing to heart failure is central to our mission," said Mark Vesely, principal investigator and assistant professor of medicine at the University of Maryland School of Medicine. "It is remarkable and very encouraging to see significant changes in clinically meaningful parameters this early in the study. We look forward to the additional data that will be gathered as the study progresses, which will help us to better understand both the magnitude and durability of the benefit to treatment."

Osiris also reported that it has won two U.S. patents that cover how Prochymal works to repair damaged cardiac tissue. The Columbia company said it now has 48 U.S. patents for its stem cell treatments.

It also said that it improved its patent estate in Europe and Australia for its stem cell treatments to reduce inflammation.

"These recent additions to Osiris patent estate, combined with the existing broad coverage of our pioneering [mesenchymal stem cell] platform technology, reinforce our ... portfolio and bolster our dominant position regarding the manufacture and use of mesenchymal stem cells for the treatment of a broad range of diseases, said Chris Alder, the company's chief intellectual property counsel, in a statement. We have invested significant time and resources building our intellectual property estate, and with the commercialization of Prochymal, we are preparing to take the necessary action to enforce our considerable rights.

Prochymal is approved in Canada and New Zealand, and is available in seven other nations, including the U.S., under an expanded access program for certain patients, to treat acute graft-versus-host disease in children.

The product also is being tested in clinical trials to treat refractory Crohns disease and type 1 diabetes.

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Gazette.Net: Biowatch: Osiris stem cell treatment shows promise for heart attacks