Date: 2015-06-22
Type of information: Interim results
phase: 2a
Announcement: interim results
Company: Bone Therapeutics (Belgium) Erasme University Hospital (Belgium)
Product: PREOB®
Action
mechanism: cell therapy. PREOB® is an autologous osteoblastic (bone forming) cell therapy product administered percutaneously via a minimally invasive approach, avoiding the need for surgery.
Disease: osteoporosis
Therapeutic area: Bone diseases - Regenerative medicine
Country: Belgium
Trial
details: This Phase IIa study is a six month open-label trial enrolling 20 patients with severe osteoporosis who do not respond to anti-osteoporotic treatment. PREOB® will be administered via a single intravenous infusion, and the primary endpoints of the trial will be cell body distribution and bone markers. The trial is the first of its kind to be initiated globally and will be run at the Erasme University Hospital (Free University of Brussels (ULB), Belgium). (NCT02061995)
Latest
news: * On June 22, 2015, Bone Therapeutics, the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, announced the first results of its Phase IIA PREOB® osteoporosis trial. Out of the eight patients enrolled, seven were treated in the first part of this Phase IIA trial, which aims to evaluate PREOB® in the treatment of osteoporosis patients who do not respond to anti-osteoporotic therapy. Eight patients were enrolled in the study, of whom one did not meet the eligibility (i.e., inclusion & exclusion) criteria for participating into the study and was therefore not treated. Primary endpoints of the study are safety and biodistribution of PREOB® cells administered intravenously: homing of cells to the bones most prone to osteoporotic fractures is indeed the first condition for the therapy to have effect. The biodistribution of radioactively-labelled PREOB® cells was followed during 72 hours using SPECT/CT2 scan to determine their location in the body after intravenous administration. Follow-up of this first group of patients showed a progressive accumulation of PREOB® cells into the axial skeleton (i.e., vertebrae and pelvis) after injection. This outcome, which is necessary to support future efficacy results, could lead to clinical benefits for the patient. Importantly, no serious adverse events related to the treatment were reported. In the study, patients with severe osteoporosis aged 40 to 85 years are treated by intravenous infusion of PREOB® to determine the fate of the osteoblastic cells after administration and their effect on clinical symptoms, on the occurrence of fractures and on bone turnover. * On April 16, 2013, Bone Therapeutics, a biopharmaceutical company focused on innovative cell therapy products for the treatment of bone diseases, has announced that its partner, the Rheumatology Department of Erasme University Hospital (Brussels, Belgium), has initiated a Phase IIa trial with its lead bone cell therapy product PREOB® for the treatment of severe osteoporosis patients who do not respond to pharmacological treatment. This cell therapy product is currently in two pivotal Phase III trials for the treatment of osteonecrosis and non-union fractures. Bone Therapeutics has been granted from the Free University of Brussels an exclusive worldwide license for PREOB® currently in Phase III clinical trials. The company was founded in 2006 based on the pioneering works carried out at Erasme University Hospital-ULB.
