Bone Therapeutics treats second patient cohort in ALLOB® Phase I/IIA delayed-union fracture trial
Safety Monitoring Committee confirms safety of treatment and recommends the trial to continue as planned
Gosselies, Belgium, 7 September 2015 - BONE THERAPEUTICS, the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, today announces it has completed treatment without any safety concerns of the second cohort of patients in the ALLOB® Phase I/IIA trial for patients with delayed-union fractures.
The Safety Monitoring Committee, composed of medical experts, met to review the initial safety data of the two cohorts and following analysis of clinical, laboratory and biological parameters, the committee unanimously agreed that the trial can proceed as planned and can continue to enrol patients.
Enrico Bastianelli, CEO of Bone Therapeutics commented: "This is the first trial in which our allogeneic1 bone cell therapy product is being evaluated and we are pleased to have reached this important patient treatment milestone without any safety issues. We were very encouraged with the positive efficacy results previously reported from the first cohort of patients in the trial and we look forward to updating the market on the efficacy of this second patient cohort."
The ongoing Phase I/IIA study is a six-month open-label trial to evaluate the safety and efficacy of Bone Therapeutics’ allogeneic bone cell therapy product, ALLOB®, in the treatment of delayed-union fractures of long bones. The study is targeting the recruitment of 32 patients, but is flexible and could be prematurely stopped due to efficacy after an interim data analysis of the 16 first patients. To date, eight patients with a fracture that had failed to consolidate after a minimum of three and a maximum of seven months, have received a single percutaneous administration of ALLOB® directly into the fracture site. Fracture healing of ALLOB®-treated patients is assessed using clinical (e.g., pain, weight bearing) and radiological evaluation.
One patient of the second cohort has also been included in a sub-study to investigate the biodistribution of the ALLOB® cells through the body and to confirm their presence at the fracture site after administration. By radioactively labelling a fraction of the ALLOB® cells before injection, the cells can be traced up to 72 hours after administration using SPECT scans2. Results from this sub-study are an important support for future efficacy results, as the continued gathering of the cells at the fracture site is important for the therapy to have an optimal effect.
1 Where cells are derived from a healthy donor, rather than the patient.
2 A SPECT (Single Photon Emission Computed Tomography) scan visualizes the radioactive label attached to the cells in order to determine their location in the body. This is combined with a CT scan, that visualizes anatomical structures using x-ray, to allow specification of the exact location.