Cytori Therapeutics Update On U.S. Phase III Scleroderma Trial

(RTTNews) - Cytori Therapeutics, Inc. (CYTX) announced that its U.S. FDA approved Phase III STAR trial has enrolled and treated its 40th patient (50% of target enrollment). In addition, a pre-specified independent data monitoring committee review of safety data from the initial 20 patients has been conducted and the committee has recommended that the study continue as planned.

STAR is a randomized, placebo-controlled, double-blind, parallel group Phase III FDA approved pivotal study investigating the efficacy and safety of Cytori ECCS-50 therapy injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients will be randomized with 40 receiving ECCS-50 therapy and 40 receiving placebo.

The double-blind period extends to 48 weeks. After all patients have completed 48 weeks follow-up, the placebo patients will be offered active treatment should they desire treatment and continue to qualify. The trial began enrollment in August 2015 with enrollment expected to be completed by mid-2016.