ALD-401: Phase II data

The double-blind, U.S. Phase II RECOVER-Stroke trial in patients with neurological damage arising from an ischemic stroke showed that an intracarotid infusion of 3 mL ALD-401 given 13-19 days post-stroke missed the primary endpoint of improving mean mRS scores from baseline to day 90 vs. sham control. Cytomedix also said there were no differences between treatment groups on secondary endpoints. No serious adverse events attributable to ALD-401 were reported. The trial enrolled 48 patients. The company will discontinue further funding of the ALDH Bright Cell program evaluating the product to treat stroke and close its R&D facility in Durham, N.C. Cytomedix expects the closure to save about $4 million per year. ...