Positive results in the first cohort of four patients treated with Bone Therapeutics' novel allogeneic product for delayed-union fractures
BONE THERAPEUTICS, the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and fracture prevention, today announces 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. Today, 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.
The fact that three out of the four treated delayed-union fractures have fully consolidated in such a short period of time demonstrates the strength of this product. Safety in the study was also recently confirmed by a Safety Monitoring Committee, which unanimously recommended the trial should progress as planned.
Commenting on today's announcement, Enrico Bastianelli, CEO of Bone Therapeutics, 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."
ALLOB® is a first-in-class allogeneic osteoblastic cell product with regenerative properties, developed for the treatment of bone diseases. "Allogeneic" means that the cells are harvested from a healthy, universal donor, as opposed to "autologous" where the cells come from the patient him/herself. ALLOB® is currently tested in two Phase I/IIa clinical trials for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine. ALLOB® has been classified as a tissue engineered product under the ATMP regulation 1394/2007EMA.
About Delayed-Union Fractures
A delayed-union fracture is defined as a bone that has not healed within the expected normal period of time after the initial injury (i.e., 3 to 4 months) and is at risk of non-healing. Traditional options for the treatment of an impaired fracture (i.e., bone graft) typically involve highly invasive surgery, which can be painful and require months of rehabilitation with the risk of serious complications (such as deep bone infection). Due to the risks of the current treatment, orthopaedic surgeons often take a "wait and see" approach to the treatment of delayed-union fractures, sometimes for several months, which delays the patient's return to a normal life and leads to a significant financial burden to society. ALLOB® has the potential to become a first-line and early treatment for delayed-union fractures, thanks to its minimally invasive administration which avoids the need for major surgery.
Bone Therapeutics is a leading biotechnology company specializing in the development of innovative regenerative therapies for the repair and prevention of bone fractures. The current standard of care in this field involves major surgeries and long recovery periods. To overcome these problems, Bone Therapeutics is developing a range of innovative products containing regenerative osteoblastic/bone-forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.
PREOB®, Bone Therapeutics' autologous cell product, is currently in pivotal Phase III clinical studies for two indications: osteonecrosis and non-union fractures, and in Phase II for severe osteoporosis. ALLOB®, its allogeneic cell product, is in Phase II for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine. The Company also runs preclinical research programs and develops novel product candidates.
Founded in 2006, Bone Therapeutics is headquartered in Gosselies (South of Brussels, Belgium). Bone Therapeutics' regenerative products are manufactured to the highest GMP standards and are protected by a rich IP estate covering 9 patent families. Further information is available at http://www.bonetherapeutics.com
For further information, please contact:
Bone Therapeutics SA
Enrico Bastianelli, Chief Executive Officer/ Wim Goemaere, Chief Financial Officer [email protected]