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TOPIC: Calabrius can start a CLI Phase III in Japan

Calabrius can start a CLI Phase III in Japan 18 Apr 2016 08:53 #6838

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Calabrius (CLBS) - formerly NeoStem- makes a nice jump today...

BASKING RIDGE, N.J., April 18, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (CLBS) (“Caladrius” or the “Company”), a leading cell therapy company combining an industry-leading development and manufacturing services provider with a select therapeutic product pipeline, announces that the Japanese 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 Company’s 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.

The Company believes the study design is sufficient to achieve conditional approval for CLBS12 in Japan for the treatment of CLI. The agreed trial is a 35-patient Phase 2, prospective, randomized, controlled, multicenter study in patients with no-option CLI conducted in Japan. Those patients randomized to treatment will be dosed with autologous G-CSF-mobilized peripheral blood-derived CD34+ cells (CLBS12) through intramuscular injection in addition to standard of care. Patients randomized to the control arm will receive standard of care pharmacotherapy alone.

“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,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “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 has decided to aggressively pursue this registration pathway in Japan largely due to the recent Regenerative Medicine Law passed 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.

“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, which we intend to demonstrate through this pivotal study,” said Dr. Atsuhiko Kawamoto, principal investigator for this pivotal Phase 2 trial for CLBS12.

Dr. Kawamoto is the Director of the Unit of Regenerative Medicine and Leader of the Vascular Regeneration Research Group at the Institute of Biomedical Research and Innovation in Kobe, Japan. He is also the Vice Director of the Translational Research Informatics Center at the Foundation for Biomedical Research and Innovation.

This is interesting that the clinic requires 35 patients for conditional approval. As Hedrick briefly indicated at the end of the New York presentation- the private investigator trial in Japan for PAD/CLI and related disorders had 40 patients- should be ready- and it is assumed that Cytori as well as the investigator will be interested in pursuing the same approval. :whistle:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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