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