Date: 2014-12-04
Type of information: Initiation of the trial
phase: 3
Announcement: update
Company: Bone Therapeutics (Belgium)
Product: PREOB®
Action
mechanism: cell therapy. PREOB® is a cell therapy product. PREOB®, a first-in-class second generation Advanced Therapy Medicinal Product (ATMP), is an autologous bone cell medicinal product administered percutaneously via a minimally invasive approach, avoiding the need for surgery.
Disease: osteonecrosis
Therapeutic area: Bone diseases - Regenerative medicine
Country: Belgium, France, Germany, The Netherlands, UK
Trial
details: This pivotal phase III trial aims at reproducing the positive pilot trial results where the implantation of PREOB® has been shown to halt or revert the progression of the disease and to significantly improve pain and hip function in patients with early stage osteonecrosis, compared to the reference group. This trial is anticipated to be the last phase of testing before obtaining the approval for commercialization. The trial will be conducted in 20 to 25 centres in Europe. It will enroll 130 patients with early stage osteonecrosis. Patients will be randomized to receive either PREOB® or a placebo in double-blind controlled study design. This trial will be the first double-blind pivotal trial of its class. (NCT01529008)
Latest
news: * On December 4, 2014, Bone Therapeutics, the regenerative therapy company addressing unmet medical needs in the field of bone fracture repair and fracture prevention, 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.
* On November 7, 2013, Bone Therapeutics has announced that its phase III pivotal trial to treat osteonecrosis with PREOB® is actively running in 30 European centres. Today, 30 centres across Belgium, Germany, France and the Netherlands are active and ready to recruit patients to assess the safety and efficacy of PREOB® in early stage osteonecrosis of the femoral head.* On December 1, 2012, Bone Therapeutics has announced that after receiving clearance from the competent authorities in Europe, its PREOB® phase III pivotal trial to treat osteonecrosis has started with the first patients included in the study. PREOB®, being developed under an orphan drug designation granted both in Europe and in the USA, will be the first conservative treatment for this indication.
