December 2, 2015 9:00am

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.


 

The finding of sustained benefit at two-year followed 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 http://rheumatology.oxfordjournals.org/content/early/2015/09/08/rheumatology.kev323.abstract .

  • 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 P3/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.

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.

 

The Bottom Line:  CYTX will validate the observations of sustained benefit in the ongoing P3 pivotal trial in the US as it is encouraging to see maintenance of the response in patients at a full two years after only a single administration!  More specific 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.

  • 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.

 

CYTX closed -$0.01 at $0.36 and is UP <so far> in the pre-market +$0.01.  News flow has picked-up and CYTX should be feeling the effect of positive results. I always love good beginnings as they foretell and fulfil the hope ofsustained improvement in four key endpoints of treatment. CYTX has FINALLY found the right mix of focus and should be … REWARDED - Strong BUY.

 

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 approximately100,000 patients and in the US is approximately 50,000 patients.