Successful 12 months follow up for ECCS-50 in Scleradec-I trial for Scleroderma- Cytori Therapeutics

Cytori Therapeutics has announced the publication of the results from the 12 month clinical follow up of patients enrolled in the Scleradec-I clinical trial from hand dysfunction common in patients with the rare disease scleroderma.

The Scleradec-I trial, an investigator-initiated, open-label 12 patient trial, was led by Dr. Brigitte Granel and Dr. Guy Magalon from the Assistance Publique des Hôpitaux de Marseille. The manuscript was published in the journal Rheumatology .The publication documented that a single treatment with Cytori Cell Therapy, known as ECCS-50, provided prolonged improvements in patients with impaired hand function due to scleroderma. Specifically, hand function assessed using the validated clinical measure known as the Cochin Hand Function Scale and overall health status using the Scleroderma Health Activity Questionnaire improved from baseline by an average of 51.3% and 46.8%, respectively, at 12 months (p=0.001 for both). Raynaud’s Condition Score, which measures the incidence and severity of Raynaud’s phenomena, was reduced by 63.2% from baseline at 12 months (p<0.001). Other key findings include a 30.5% improvement from baseline in grip strength (p=0.002) and 34.5% improvement from baseline in pain (p=0.052). Relative to the data measured in these patients at 6 months after treatment, the 12 month data included evidence of on-going benefit across a number of endpoints. For example, fibrosis of the hand, an important pathophysiologic feature of the disease, was assessed using the modified Rodnan Skin Score and declined by 22.9% relative to baseline (p=0.014). Similarly, capillaroscopic assessment of vascular suppression improved by 35% compared to baseline (p=0.001). The follow on European Phase III trial known as Scleradec II is a larger, randomized, controlled trial designed to substantiate these findings and is anticipated to begin before the end of the year.