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Home » ORTHOLOGIC ENDS STUDY OF CHRYSALIN IN FRACTURE REPAIR
ORTHOLOGIC ENDS STUDY OF CHRYSALIN IN FRACTURE REPAIR
August 30, 2006
OrthoLogic announced results of an interim analysis of data from its Phase IIb dose-ranging clinical trial of the synthetic peptide Chrysalin (TP508) in unstable, displaced wrist fractures. Based on the results, the company has decided to terminate the study.
The trial was a prospective, double-blind, randomized, placebo-controlled, multisite, five-arm, dose-response study. The five arms correspond to Chrysalin dosages of 1, 3, 10 and 30 micrograms and placebo. The study, which enrolled 274 patients, was designed to evaluate the safety and efficacy of these doses of Chrysalin on the rate of healing in adult subjects with unstable and/or displaced distal radius fractures.
The primary efficacy endpoint was time to removal of all rigid immobilization used to stabilize the fracture, defined as the time elapsed between the date of fracture surgery and the first study visit at which the investigator, based on clinical and radiographic assessments of healing, removed all rigid immobilization hardware. Chrysalin did not demonstrate benefit compared with placebo in meeting this endpoint. Further, no dose-response relationship was observed. The trial did meet the pre-specified safety endpoint by demonstrating no significant difference in the incidence of adverse events between the Chrysalin and placebo groups.
KEYWORDS Drug Pipeline Alert
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