Belgium-based biotechnology firm Bone Therapeutics has reported positive efficacy results from the first cohort of four patients enrolled in the Phase I/IIa delayed-union trial with its allogeneic bone-forming cell product ALLOB.
ALLOB is a first-in-class allogeneic osteoblastic cell product with regenerative properties, developed to treat bone diseases.
The results showed that all four patients treated with ALLOB met the primary endpoints of the trial and three patients have been completely healed.
The ongoing six-month open-label Phase I/IIa trial is designed to evaluate the safety and efficacy of ALLOB to treat delayed-union fractures of long bones.
Currently, the first group of four patients with a fracture that had not consolidated after a minimum of three and a maximum of seven months, has been treated.
In the trial, each patient received a single percutaneous administration of ALLOB directly into the fracture site.
Fracture healing of patients treated with ALLOB is evaluated in comparison to baseline at two weeks, one, three and six months using clinical and radiological evaluation.
The company said that treatment success will have been achieved when the health status of the patient has improved by at least 25% and the radiological score, as evaluated by CT scan, has increased by at least two points versus baseline.
Recently, a Safety Monitoring Committee has confirmed safety in the trial and has unanimously recommended the trial should progress as planned.
Bone Therapeutics CEO Enrico Bastianelli said: "These results, coupled with the recent confirmation of safety in the trial, are very encouraging.
"The radiological improvement confirms that the treatment is, so far, successful and confirms our belief that ALLOB will offer significant benefit to patients. We are looking forward to progressing the trial to the next cohort of patients."