Positive results for Bone Therapeutics’ novel allogeneic product for delayed-union fractures
Bone Therapeutics announced positive efficacy results for the first cohort of four patients enrolled in the Phase I/IIA delayed-union trial with its allogeneic bone-forming cell product ALLOB®. Results from the initial four patients showed that all four ALLOB®-treated patients met the primary endpoints of the study and three patients have completely healed.
The ongoing Phase I/IIA study is a six month open-label trial to evaluate the safety and efficacy of ALLOB® in the treatment of delayed-union fractures of long bones. The first cohort of four patients with a fracture that had not consolidated after a minimum of three and a maximum of seven months has been treated. Each patient received a single percutaneous administration of ALLOB® directly into the fracture site. Fracture healing of ALLOB®-treated patients is assessed in comparison to baseline at two weeks, one, three and six months using clinical (e.g., pain, weight bearing) and radiological evaluation. Treatment success will have been achieved when the health status of the patient has improved by at least 25% and the radiological score, as assessed by CT scan, has increased by at least two points versus baseline.
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