Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced today that it has completed enrollment in a human clinical trial designed to evaluate Prochymal, the Company’s proprietary formulation of adult mesenchymal stem cells, for the treatment of moderate to severe Chronic Obstructive Pulmonary Disease (COPD). A total of 62 patients were enrolled in the Phase II trial at six sites throughout the United States.

“These stem cells have qualities that make them naturally well suited for the repair of lung tissue, and early clinical data are so far very encouraging,” said Michelle LeRoux Williams, Ph.D., Vice President of Development at Osiris Therapeutics. “We are excited to learn more about the therapeutic utility of these cells in the lungs, not only for the treatment of COPD, but for other pulmonary conditions as well. This study will provide for us the necessary base for further rapid development of this remarkable stem cell technology in what could ultimately prove to be a broad spectrum of lung diseases.”

Mesenchymal stem cells have been shown to be effective in treating numerous lung diseases in pre-clinical animal models. The ability of the stem cells to reduce inflammation, block fibrosis or scarring and repair tissue damage suggests that they may be effective in reversing or preventing the progression of COPD. In an earlier human trial for heart disease, infusions of Prochymal were shown to improve lung function by a statistically significant margin compared to patients receiving placebo.

“We would like to thank our participating physicians and their teams for the remarkable job they did enrolling this study so quickly,” said Robin Flannery, who coordinated the trial at Osiris. “But most of all, we would like to recognize and offer our sincere thanks to the patients who are participating in this historic trial. It is only with their cooperation that we seek to usher in a new era in the treatment of lung disease.”

Osiris is investigating Prochymal in patients with COPD, the fourth leading cause of death in the United States. Over 12 million Americans have been diagnosed with the disease, and it is estimated that an additional 14 million Americans have the disease and have not yet been diagnosed.

About the Phase II Chronic Obstructive Pulmonary Disease Trial

The Phase II trial is evaluating the safety and efficacy of Prochymal in conjunction with standard of care for improving pulmonary function in patients with moderate to severe COPD. The clinical trial is a double-blind, placebo-controlled study. Patients were randomized to either Prochymal or placebo at a 1:1 ratio.