Caladrius Biosciences Strikes Deal With Japanese Regulators on Development Plan For Its Cell Therapy

Caladrius Biosciences Inc CLBS disclosed that it struck a deal with the Japanese Pharmaceutical and Medical Devices Agency or PMDA on development plan for its Cell Therapy for critical Limb Ischemia. The company indicated that there was no comment from the regulator. As a result, Caladrius Biosciences could proceed further with the study when it was ready. The company sought an alliance to pursue the study and was in advanced discussions with possible licensing partners. The company expects to initiative the pivotal trial as late as 2016 pending consummation of an alliance deal. The company's CEO, David Mazzo, commented, "We are pleased that our interactions with the PMDA have led to the design of a relatively small and, we believe, low risk trial that could significantly advance CLBS12 and the Company's CD34 asset." Mazzo further stated that "We look forward to achieving a partnership to enable the launch of this pivotal Phase 2 trial in Japan. CLI is just the entry-point to explore the broader applicability of the CD34 platform therapy, which could potentially be effective in the treatment of chronic heart failure or dilated cardiomyopathy." Caladrius indicated that it decided to aggressively pursue this registration pathway in Japan mainly due to the recent Regenerative Medicine Law passed in November 2014. The Principal Investigator of the pivotal Phase 2 stsudy for CLBS12, Atsuhiko Kawamoto, reacted to the recent developments to say that "Based on the substantial clinical data from four prior trials in critical limb ischemia and claudication, we believe that CD34 cell therapy is not only safe, but can help improve quality of life and potentially treat patients with this serious and life-threatening condition,