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 of … sustained 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.