OrthoLogic Announces Termination of its Phase IIb Dose Response Trial
BY JOHN CHOPACK, AUGUST 30, 2006
Orthologic reported yesterday that an interim analysis of its Chrysalin Phase IIb dose response distal radius fracture healing clinical trial did not meet its primary efficacy endpoint of having a benefit over a placebo in time to removal of immobilization. It also failed to meet its secondary endpoints including radiographic healing. In addition, OrthoLogic announced that there was no difference in outcomes using 0, 1ug, 3ug, 10ug or 30ug. The Company's interim analysis was based on evaluation of 240 patients over a period of 1-8, 10, 12, 26 and 52 weeks. Although the Phase IIb hasn't finished enrolling patients, the Company has decided to terminate the study as a consequence of its interim analysis.
The termination of the PhaseIIb dose response study follows an announcement in March, 2006, that it's 503 patient Phase III trial involving Chrysalin failed to meet its primary efficacy endpoint of accelerated fracture healing. This announcement caused the stock to drop by 75% since March. The stock is down an additional 15% in pre-market trading today.
While the future of Chrysalin is unclear, management stated yesterday that "we intend to proceed with our planned approach to the U.S. and European regulatory authorities to discuss pathways forward for TP508 (Chyrsalin) in fracture repair."
