OrthoLogic: Phase 3 trial of Chrysalin in fracture repair failed to meet primary endpoint

By E. Janene Geiss

Philadelphia, March 15 - OrthoLogic Corp. announced Wednesday results of a data analysis from its phase 3 trial of the synthetic peptide Chrysalin (TP508) in wrist fractures showed that treatment did not demonstrate a statistically significant benefit compared to a placebo in the primary efficacy endpoint of time to removal of immobilization.

A secondary endpoint, radiographic evidence of time to radial cortical bridging, showed a statistically significant benefit for Chrysalin-treated subjects, according to a company news release.

This benefit mirrored findings from the phase 1/2 clinical trial that provided part of the foundation for the phase 3 study, officials said.

No difference was observed between Chrysalin treatment and a placebo in the other secondary endpoints, officials said.

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

"We will be conducting a full examination of these results in order to guide our program going forward, including a planned interim analysis of results from the ongoing phase 2b dose ranging trial of Chrysalin in distal radius fractures, which includes a 30 ug dose," James M. Pusey, president and chief executive officer of OrthoLogic, said in the release.

The company said it expects to communicate results of its interim analysis during the third quarter of 2006.

The study was a prospective, double-blind, randomized, placebo-controlled phase 3 clinical trial designed to evaluate the safety of Chrysalin and its efficacy regarding the rate of healing in adult subjects with unstable and/or displaced distal radius fractures.

Subjects were randomized to receive a single 1 mL percutaneous injection of Chrysalin at 10 ug or a placebo administered into the fracture site under fluoroscopic guidance. The trial enrolled 503 subjects at 27 centers in the United States.

Subjects were evaluated post-surgery at certain points throughout the year. The primary efficacy endpoint was time to removal of all immobilization, defined as the elapsed time between the date of fracture surgery and the first study visit at which the investigator removed all rigid immobilization hardware used to stabilize the fracture.

OrthoLogic is a Tempe, Ariz., biotechnology company focused on the development and commercialization of the novel synthetic peptide Chrysalin (TP508) in two lead indications, both of which represent areas of significant unmet medical need - fracture repair and diabetic foot ulcer healing.

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