Bone Therapeutics Authorised to Enrol Patients in the UK in Pivotal Phase III Osteonecrosis Trial with PREOB

08-Dec-2014 - Belgium

Bone Therapeutics announced that it has received authorisation from the Competent Authorities and Central Ethics Committee to enrol patients in the UK into its pivotal Phase III trial to confirm the safety and efficacy of its regenerative therapy product PREOB® in the treatment of osteonecrosis (also known as avascular necrosis, AVN).

Five UK sites, including Cambridge University Hospitals, King’s College Hospital London, Newcastle University/Newcastle upon Tyne Hospitals, University Hospital Southampton and The Royal Orthopaedic Hospital Birmingham are now approved.  A total of 37 centres across the UK, Belgium, Germany, France and The Netherlands have received authorization to conduct the Phase III trial of PREOB®, which has orphan drug status in Europe and the USA.

The phase III study is a randomized, double-blind, placebo-controlled pivotal trial that aims to confirm the safety and efficacy of Bone Therapeutics’ autologous osteoblastic or bone-forming cell product, PREOB®, in early-stage osteonecrosis of the femoral head over a 24-month period in 130 patients. PREOB® is designed as a first-line treatment as it is administered via a minimally invasive approach directly into the necrotic lesion, thereby avoiding the need for open surgery.

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