Positive results would provide further validation of the platform for cell therapy of bone of the Company
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The results of the interim analysis are expected in Q3 2018
Gosselies, Belgium, 8 June 2017, 7: 00 am BONE THERAPEUTICS (Euronext Brussels and Paris : BOTHE), society of cellular therapy bone that meets major unmet medical needs in the areas of orthopedics and bone diseases, announces today that it has finalized the recruitment of the 44 treated patients required for the interim analysis, planned in the framework of the Phase III trial of its cell therapy products autologous bone PREOB® in osteonecrosis of the hip. If the results of this interim analysis, based on a follow-up of patients for 12 months, show a signal of efficiency fort of PREOB®, the recruitment of the study could be stopped prematurely. The results of the follow-up of 12 months are expected in Q3 2018.
The interim analysis will be based on a new objective, clinically relevant, validated by the european medicines Agency (“EMA”), which reflects the added value provided to patients. This goal consists of an analysis of responders combining the variables co-primary original, without impact on the design of the study or on data collection.
The use of this new primary objective that is more restrictive and has reduced to 118 the number of patients to be recruited (against 130 originally). Also, as mentioned in the new protocol, approved by the competent authorities of the countries in which the trial is conducted, the observation of a strong signal of efficacy during the interim analysis could allow the premature termination of the study. The study is currently ongoing in centers in Belgium, France, Germany, the netherlands and the United Kingdom.
The Phase III study is a pivotal trial randomized, double-blind and controlled by placebo, for the confirmation of the safety and efficacy of PREOB® in the early stages of osteonecrosis of the femoral head for a duration of 24 months. The patients received either a single dose of PREOB® or placebo into the necrotic lesion via a process of drilling simple. The results of a previous exploratory study of Phase IIB clinical study in osteonecrosis, presented on the occasion of the annual Congress of the european of rheumatology (EULAR) in June 2016, have shown a marked improvement and long-term pain and functional ability, as well as a reduction in the risk of fracture with PREOB® compared to standard treatment.
Although uncommon, osteonecrosis is a pathology orthopedic severe and painful, characterized by the death of bone tissue, ultimately resulting in the fracture of the bone. The most common form of the disease is osteonecrosis of the hip, which leads to a collapse of the femoral head and degeneration of the joint, requiring a total hip replacement. However, this pathology usually affects young people (between 30 and 50 years of age), for which a total prosthesis of the hip is not an appropriate solution in the long term, given the duration of life is relatively limited prostheses.
Thomas Lienard, ceo of Bone Therapeutics, said : “PREOB® has provided Bone Therapeutics, a proof-of-concept major in the development of its unique platform for cell therapy of bone. The completion of recruitment for the interim analysis of the Phase III study of PREOB® in osteonecrosis is an important step in the validation of this platform, including the product allogeneic ALLOB® is in advanced stages of clinical development. We look forward to be able to announce the results of the interim analysis in Q3 2018, at the end of a period of follow up of 12 months patients, and can potentially offer a new therapeutic option for patients with this orphan disease catastrophic.”
“We are particularly pleased to have been able to treat 44 patients required for the interim analysis of the Phase III trial with PREOB® in osteonecrosis “, said Miguel Forte, Chief Medical Officer of Bone Therapeutics. “By being robust and optimized, the new analysis that we have adopted is more relevant than the initial approach to highlight the results for the patient and the value clinical. It could thus enable us to achieve a result from a number of patients are more limited, which would accelerate the conduct of the trial “.
About Bone Therapeutics
Bone Therapeutics is a leading company in the cell therapy of bone that meets major unmet medical needs in the field of orthopedics and pathology of bone. Based in Gosselies, Belgium, the Company has an extensive diversified portfolio of cell therapy products bone, in clinical development in various therapeutic areas targeting markets characterized by significant unmet medical needs and innovations limited.
Our technology is based on a unique approach and proprietary in bone regeneration, which transforms stem cells undifferentiated in cell “osteoblastic” or reconstitution of bone tissue. The administration of these cells is achieved in a manner that is minimally invasive which allows to avoid the surgical procedures heavy.
Our clinical program main is ALLOB®, a product of cellular therapy allogeneic “ready-to-use” obtained from stem cells of healthy donors, which is in phase II study in the treatment of fractures with delayed consolidation and in the spinal fusion. The Company also has a cell therapy products autologous bone, PREOB®, is obtained from the own bone marrow of patients, which is currently in Phase III of its development in the osteonecrosis and fractures with failure of consolidation.
The products of cell therapy of Bone Therapeutics are manufactured according to the standards of the GMP the more stringent, and protected by a broad IP portfolio covering nine families of patents. More information are available on our website www.bonetherapeutics.com/fr.
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