Cytori Reports Interim Data On U.S. Phase II Osteoarthritis Trial - Quick Facts

(RTTNews) - Cytori Therapeutics, Inc. (CYTX) announced top-line data as part of the pre-specified partial unblinding of 24 week follow-up data from the company's ACT-OA trial. The company noted that the data suggested beneficial effect of ECCO-50 for knee osteoarthritis.

The trial is a U.S. phase II randomized, double-blind, placebo controlled trial designed to evaluate the safety and feasibility at 48 weeks of a single intra-articular knee injection of the ECCO-50 cellular therapeutic in patients with chronic knee pain due to osteoarthritis.

"Key endpoints and trends observed thus far suggest that a beneficial effect may be attributable to a single intra-articular administration of ECCO-50 in patients with osteoarthritis of the knee. The full 48 week data set is the next important milestone in this program," said Dr. Marc Hedrick, President and CEO of Cytori Therapeutics.

The primary goal of the ACT-OA trial is to help determine safety and feasibility of ECCO-50 for osteoarthritis, provide dosing guidance and explore key trial endpoints useful for a phase III trial. As a proof of concept trial, ACT-OA was not sized or powered for statistical significance in any of the endpoints.

Cytori noted that in the 3rd quarter, following full unblinding of the data, it will be able to more fully evaluate the data. This includes 48 week follow up, patient subset analyses, and the effect on knee cartilage as measured by magnetic resonance imaging results changes between baseline and 48 weeks.