ORTHOLOGIC REPORTS POSITIVE DATA ON FRACTURE-REPAIR DRUG

OrthoLogic has announced findings of a post hoc subgroup analysis of data from its Phase III clinical trial of the novel synthetic peptide Chrysalin (TP508) in unstable, displaced distal radius (wrist) fractures.

Within the subset of female osteopenic subjects, treatment with 10 micrograms of Chrysalin demonstrated a statistically significant benefit compared with placebo in the primary efficacy endpoint of time to removal of immobilization. Secondary endpoints including clinical assessment of fracture healing (pain or motion at the fracture site), time to radial cortical bridging and time to overall radiographic healing also showed the effectiveness of Chrysalin treatment.

"Our analysis of the data suggests Chrysalin may have an important effect on bone healing in osteopenic females, a potentially compromised population," Randolph Steer, president of OrthoLogic, said. "These data are part of a post hoc subgroup analysis, and therefore provide only supporting -- rather than pivotal -- evidence of safety and efficacy."

The study was a prospective, double-blind, randomized, placebo-controlled, Phase III 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 containing 10 micrograms of Chrysalin or placebo administered into the fracture site under fluoroscopic guidance. A total of 503 subjects were enrolled at 27 centers in the U.S.

In this post hoc subgroup analysis, subjects were stratified by bone density score (T-score, determined by DXA scan) and grouped as normal, osteopenic or osteoporotic. A total of 157 female subjects were characterized as osteopenic. Radiographic evaluation of this osteopenic female population showed statistically significant differences between the Chrysalin-treated and placebo subjects for two of three radiographic parameters measured: time to radial cortical bridging and time to overall radiographic healing.