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Latest UpdatesU.S. cell therapy company, Caladrius Biosciences, expands to begin Phase II clinical trials

Jul 28, 2016


Caladrius Biosciences, Inc.External site: a new window will open.a leading cell therapy company combining an industry-leading development and manufacturing services provider with a select therapeutic product pipeline, announced in April 2016 that Japan's Pharmaceutical and Medical Devices Agency's (PMDA) thirty-day review period of the company's Clinical Trial Notification (CTN) for a pivotal Phase 2 trial investigating the Caladrius' CLBS12 product candidate, a CD34 cell therapy for critical limb ischemia (CLI), has now passed without further comment from the PMDA. Accordingly, Caladrius is allowed to proceed with the trial when ready. The company is seeking a partnership in order to pursue this trial, and is currently in advanced discussions with potential licensing partners. Pending consummation of a partnering agreement, Caladrius expects that the pivotal trial could initiate as early as late 2016.

Caladrius has decided to aggressively pursue this registration pathway in Japan largely due to the recent implementation of the Pharmaceuticals and Medical Devices Act in November 2014. The legislation expedites the development and commercialization of regenerative medicine therapies and grants conditional approval for regenerative medicines that demonstrate safety and the likelihood for efficacy.

JETRO has been supporting Caladrius' expansion into Japan by providing information regarding the new regulations in Japan as well as assistance with the registration of its subsidiary Neostem K.K. in Japan. For more than a year, JETRO has also provided introductions to PMDA regulatory officials, Japanese pharmaceutical partner candidates, and Japanese translation support to promote cross border business relations with the company's counterparts in Japan. In August 2014 the company completed its registration and is currently using the laboratory facilities of Kobe's Foundation for Biomedical Research and Innovation. Caladrius is now seeking an exclusive Japanese licensing, development and commercialization partner for the CD34 cell therapy program targeting the lead indication critical limb indication and follow-on indication of chronic heart failure.

For further information, please contact Dr. Douglas Losordo, Chief Medical Officer at Caladrius Biosciences at
dlosordo@caladrius.com

Caladrius Biosciences, Inc.