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TOPIC: STAR Update

STAR Update 25 Jan 2016 06:32 #6096

  • fas
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01/25/2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that its U.S. FDA approved Phase 3 STAR trial has enrolled and treated its 20th patient (25% of target enrollment). In addition, as per the trial protocol, an independent data monitoring committee has reviewed safety data from the initial 10 patients and recommended that the study continue as planned. The 20 procedures, including the fat harvest from small volume liposuction and the finger injections have all been completed successfully and well tolerated.

“We are very encouraged by the study progress and the commitment of our study centers to the STAR trial. In addition, we have been able to demonstrate that same day fat harvest, cell processing and finger injection is feasible and has been performed safely in multiple U.S. centers, as was demonstrated in the single center SCLERADEC-I trial performed in France,” 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 Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients will be randomized with 40 receiving Cytori Cell 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 at the following link: clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5

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 data indicated that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through one-year post-treatment.

Top line data announced in December 2015 of two year follow-up were consistent with sustained benefit in patients with hand dysfunction associated with scleroderma treated with Cytori Cell Therapy. The data will be presented at the forthcoming 4th World Systemic Sclerosis World Congress to be held February 18-20, 2016 in Lisbon, Portugal ( www.sscworldcongress.org ).

Cytori announced in January 2016 that it entered into an agreement with Idis to establish a Managed Access Program (MAP) for its cellular therapeutic in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. Managed Access Programs provide 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 source of medicine funding varies and may include the hospital’s budget or country’s sickness fund or social security system.

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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:

STAR Update 09 Feb 2016 11:29 #6266

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The last 5 STAR trial centers have been slow to open enrollment but I see The Cleveland Clinic site is now open.

For those who don't know...Cleveland Clinic is a premier health care institution.
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