OrthoLogic stops Chrysalin trial evaluating fracture repair

By Elaine Rigoli

Tampa, Fla., Aug. 29 - OrthoLogic Corp. said interim analysis of data of 240 subjects in the phase 2b trial testing Chrysalin (TP508) showed that it did not demonstrate benefit compared to a placebo in the primary efficacy endpoint of time to removal of immobilization.

Individual findings of efficacy in secondary endpoints, including radiographic healing, were not seen in this interim analysis. Further, no dose-response relationship was observed.

The trial met the pre-specified safety endpoint by demonstrating no significant difference in the incidence of adverse events between the Chrysalin and placebo groups.

Based on these results, the company has terminated the study with no further recruitment of subjects. The interim analysis will continue, and any significant findings will be disclosed as appropriate, the company said.

"We interrupted enrollment in the phase 2b clinical trial in mid-March 2006 in order to perform the interim analysis of subjects enrolled to that date," president Randolph C. Steer said in a news release.

"This trial was not powered at the interim-analysis stage to detect statistically significant differences among dose cohorts regarding the efficacy of Chrysalin. We had hoped to discern a dose response curve through this trial design."

The company said it will continue with its planned approach to the U.S. and European regulatory authorities to discuss pathways forward for TP508 in fracture repair.

OrthoLogic, with headquarters in Tempe, Ariz., is a biotechnology company.

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