Cytori Says STAR Trial Fails To Meet Primary Or Secondary Efficacy Endpoints

(RTTNews) - Cytori Therapeutics Inc. (CYTX) announced preliminary data from its pivotal STAR trial of HabeoTM Cell Therapy in patients with scleroderma. While the primary endpoint, Cochin Hand Function Score (CHFS), did not reach statistical significance at 24 or 48 weeks, the trial data reported clinically meaningful improvements in the primary and secondary endpoints of both hand function and scleroderma-associated functional disability, for Habeo treated patients compared to placebo, in a subgroup of patients with diffuse cutaneous scleroderma.

The U.S. multi-center STAR trial enrolled and evaluated 88 patients with scleroderma, including 51 patients within the diffuse cutaneous subset and 37 with limited cutaneous scleroderma. In the combined study population, the primary endpoint, specifically mean improvement in the Cochin Hand Function Score, did not show statistical difference between treated patients and those receiving placebo at 24 weeks and 48 weeks as determined by both analysis of covariance and mixed model repeated measure analysis.

The Raynaud's Condition Score, a secondary endpoint, improved in both the treatment and placebo group but was not statistically different between the Habeo treated and placebo groups.