OrthoLogic has abandoned a multi-dose Phase IIb study of its experimental fracture repair drug Chrysalin after it failed to produce better results than a placebo. Investigators had been testing five different doses of Chrysalin, but determined that patients were not able to remove their casts any quicker after taking the drug. OrthoLogic researchers will now focus on advancing TP508 for fracture repair.
"We interrupted enrollment in the Phase IIb clinical trial in mid-March 2006 in order to perform the interim analysis of subjects enrolled to that date," said Randolph C. Steer, MD, president of OrthoLogic. "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."
- here's the AP report on the clinical trial failure