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TOPIC: FDA Scleroderma Phase III Enrollment Update

FDA Scleroderma Phase III Enrollment Update 24 Mar 2016 06:20 #6699

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03/24/2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that its U.S. FDA approved Phase III STAR trial has enrolled and treated its 40th patient (50% of target enrollment). In addition, a pre-specified independent data monitoring committee review of safety data from the initial 20 patients has been conducted and the committee has recommended that the study continue as planned.

“We remain encouraged by how well the trial procedures have been tolerated and how the procedures have been instituted across the 20 study sites around the country. We are grateful to the investigators, research staff and especially the patients who have participated and enabled us to remain on track to complete enrollment in mid-2016,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics.

STAR is a randomized, placebo-controlled, double-blind, parallel group Phase III FDA approved pivotal study investigating the efficacy and safety of Cytori ECCS-50 therapy injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients will be randomized with 40 receiving ECCS-50 therapy and 40 receiving placebo. The double-blind period extends to 48 weeks. After all patients have completed 48 weeks follow-up, the placebo patients will be offered active treatment should they desire treatment and continue to qualify. The trial began enrollment in August 2015 with enrollment expected to be completed by mid-2016. Details of the STAR trial including inclusion and exclusion criteria can be found on clinicaltrials.gov.

The STAR trial follows the twelve patient SCLERADEC-I pilot trial in which one year post-treatment results were published in the August 2015 edition of the journal Rheumatology. The two year results have recently been presented at the Systemic Sclerosis World Congress in Lisbon, Portugal. The data indicated that a single administration of ECCS-50 therapy was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through two years following treatment.

Cytori announced in January 2016 that it entered into an agreement with Idis to establish a Managed Access Program (MAP) also, known as a named patient or compassionate use program, for its cellular therapeutic in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. A MAP provides biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available. The sources of medicine funding varies by country and may be derived from a combination of the government, hospital, insurer and patient.

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FDA Scleroderma Phase III Enrollment Update 24 Mar 2016 07:46 #6701

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Wall Street Titan wrote: 03/24/2016

“We remain encouraged by how well the trial procedures have been tolerated and how the procedures have been instituted across the 20 study sites around the country. We are grateful to the investigators, research staff and especially the patients who have participated and enabled us to remain on track to complete enrollment in mid-2016,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics.


From the above text , one would assume that all sites are recruiting now. The record at clinicaltrials.gov , which was last updated on March 16 i.e 8 days ago, still had the 16 which have been recruiting for some time now. All seems well. The investigators seem very motivated and Cytori informing its shareholders at least on the things they appear to be able to control....We are making progress :winky:

Record link: HERE

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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:

FDA Scleroderma Phase III Enrollment Update 24 Mar 2016 08:16 #6702

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I wonder what the deal is with those last 4 sites....since we got that update last week why didn't the number of enrolling sites increase ?
At this point there are probably close to having all of the patients needed at least "in cue" for mid year completion.

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