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TOPIC: 2 Years Sustained Benefit in SCLERADEC-I

2 Years Sustained Benefit in SCLERADEC-I 02 Dec 2015 06:11 #5554

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Very encouraging.. :nice:

12/02/2015
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the finding of sustained benefit at two-year follow-up in the SCLERADEC-I trial of Cytori Cell Therapy (ECCS-50) in patients with hand dysfunction associated with scleroderma.

The SCLERADEC-I trial is an investigator-initiated, open-label, 12 patient trial, led by Dr. Brigitte Granel and Dr. Guy Magalon from the Assistance Publique des Hôpitaux de Marseille. A manuscript describing in detail the data from baseline to 12 months follow-up was recently published in the journal Rheumatology [ rheumatology.oxfordjournals.org/content/early/2015/09/08/rheumatology.kev323.abstract ].

The two-year follow up data in the SCLERADEC-I trial, demonstrated sustained improvement in four key endpoints: (1) Cochin Hand Function Score (CHFS), (2) Scleroderma Health Assessment Questionnaire, (3) Raynaud’s Condition Score (which assesses severity of Raynaud’s Phenomenon), and (4) hand pain, as assessed by a standard visual analogue scale.

“It is encouraging to see maintenance of the response in patients treated with Cytori Cell Therapy at a full two years after only a single administration,” said Steven Kesten, MD, Chief Medical Officer at Cytori. “We hope to validate the observations of sustained benefit in the ongoing phase III pivotal trial in the United States.”

Average values at the two-year timeframe for all four of these end points were statistically significantly improved over baseline and similar to improvements observed at one year. As with the previous studies, no safety issues related to Cytori Cell Therapy were reported. These data, along with other endpoints from the SCLERADEC-I trial, will be presented in detail by Dr. Magalon at the 4th Systemic Sclerosis World Congress to be held in Lisbon, Portugal in February, 2016.

Two follow-on, late-stage trials, STAR in the United States, and SCLERADEC-II in France, are currently enrolling patients.

STAR is an eighty patient randomized, double-blind, placebo-controlled Phase III/Pivotal trial of a single dose of Cytori Cell Therapy (ECCS-50) compared to placebo. Enrollment in the STAR trial began in August of 2015. Details of the trial can be found at: clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5
SCLERADEC-II is a forty patient, multicenter, randomized, double-blinded, controlled trial of a single administration of Cytori Cell Therapy (ECCS-50), compared to placebo. Enrollment in the trial began in October 2015. Full details of the SCLERADEC-II trial can be found at: clinicaltrials.gov/ct2/show/NCT02558543?term=SCLERADEC&rank=1
About Scleroderma

Systemic sclerosis (SSc) or scleroderma is a rare disease that leads to hand impairment in nearly 90% of patients. In addition to general measures to protect the hand, patients require medications which often are inadequate to control symptoms or prevent complications. This patient population has a dire unmet need for effective treatments. The prevalence in Europe is approximately 100,000 patients and in the US is approximately 50,000 patients.

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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:

2 Years Sustained Benefit in SCLERADEC-I 02 Dec 2015 06:33 #5555

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Interesting since sustainability with scleroderma was specifically ask by someone in the last call.

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2 Years Sustained Benefit in SCLERADEC-I 02 Dec 2015 07:38 #5556

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Three in a row is becoming a pattern!

Next up is news about delisting (hopefully a six month extension), then ACT-OA results (my guess is March 1st). Of course a EU partnership on Scleroderma could happen any day as could a US partnership on OA. The next three months could be a little boring watching the clock.

Still, good progress and good outcomes.
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2 Years Sustained Benefit in SCLERADEC-I 02 Dec 2015 19:04 #5569

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DOV, after Tiago came, there has been a pattern of 3 consecutive news releases over 3 days. I think for the 4th Q, news releases seem to be dry.to date. CYTX always presents in an investors conference at the beginning of the new year and most presentation materials are past dated. Does it mean that there will be more PRs coming for December to color the January presentation, if there is indeed news?

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2 Years Sustained Benefit in SCLERADEC-I 03 Dec 2015 13:27 #5583

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DOV, I think we may see OA Knee week results sooner. November 27 was the 24 week mark since the last patient enrolled so if all went according to plan, all data has been already been collected and most of it was collected months ago.

6/15/2015
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ: CYTX) announced today that enrollment has been completed in its US Phase IIb Osteoarthritis trial. The ACT-OA trial is a double-blind randomized, placebo-controlled trial evaluating the safety, feasibility and dosing of intraarticular administration of Cytori’s ECCO-50 cellular therapeutic in patients with knee osteoarthritis. A total of 94 patients were enrolled as of June 12, 2015.

“Based on faster than anticipated enrollment, we now expect to have six month follow up data for review in Q1 2016. We are very encouraged by the rate of recruitment, which was completed months ahead of the original plan,” said Marc Hedrick, CEO and President, Cytori Therapeutics. “Based on 24 week follow-up outcomes, we will provide an update on the data and the Phase 3 design, including the size of the trial, cost and end points."

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