Osiris initiates Phase II study of COPD drug

This trial marks the sixth indication for which Prochymal has been advanced into Phase II or later-stage clinical trials. The Phase II trial will evaluate the safety and efficacy of Prochymal in conjunction with standard of care for improving pulmonary function in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The clinical trial is a double-blind, placebo-controlled study conducted at multiple sites with a target enrollment of 60 patients.

Patients will be randomized to either Prochymal or placebo at a 1:1 ratio. Pulmonary function tests, exercise capability, and quality of life are some of the measurements being used to detect potential improvements in subjects treated with Prochymal. In addition, exacerbations and hospitalizations due to COPD will be monitored for both safety and efficacy. Patients will be evaluated over the course of two years following initial Prochymal or placebo infusion.

Randal Mills, president and CEO of Osiris, said: “This supports our strategy to seek initial approval for the world’s first stem cell drug in relatively small underserved diseases, such as GvHD and resistant Crohn’s disease, and promptly expand the technology to include blockbuster markets for which the technology also holds great promise.”