ALLOB® Delayed-Union Program Awarded at Cells Orthopedics Conference
Peer review panel praises scientific value and medical relevance of ALLOB® Phase I/IIA in delayed-union fractures
Gosselies, Belgium, 11 December 2015 - BONE THERAPEUTICS the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, announces that it has been awarded a gold prize for an abstract on the Phase I/IIA trial of its ALLOB® allogeneic cell therapy in delayed-union fractures of long bones.
The abstract, “A pilot Phase I/IIA, multicentre, open proof-of-concept study on the efficacy and safety of allogeneic osteoblastic cells (ALLOB®) implantation in non-infected delayed-union fractures” by Elisa Llinares, PhD, Audrey Colliou, PharmD and Enrico Bastianelli, MD, MBA, was awarded the top prize on December 4th, following the Cells: Orthopedics conference 2015 in Palma Mallorca, Spain, held November 13th – 15th. The abstract beats other contestants to be recognised by the Clinical and Scientific Advisory Board of the conference based on scientific or clinical value, originality, categorical relevance and overall presentation and conclusion. The poster can be accessed here: http://rgnmed.com/gold-winner-osteoblastic-cell-based-therapy-for-delayed-union-fractures/.
The poster outlines the Company’s unique approach to the development of cell therapy products for bone fracture repair and prevention, details findings from preclinical studies on Bone Therapeutics’ bone formation model and outlines the parameters of the ongoing Phase I/IIA study of ALLOB® in delayed-union fractures.
This Phase I/IIA trial is a six-month, open-label trial for the treatment of delayed-union fractures of long bones. The Company recently reported excellent safety and efficacy from the treatment of the initial four patients and has successfully treated a second cohort of patients without any safety issues. The trial is targeting the recruitment of 32 patients in Belgium, Germany and the UK but is flexible and could be stopped earlier if efficacy is seen following an interim data analysis of the first 16 patients. The poster presented outlined preclinical findings before updating on the progress of the Phase I/IIA trial.
Enrico Bastianelli, CEO of Bone Therapeutics commented: "This is the first trial to investigate an allogeneic bone cell therapy product, and we are very enthusiastic about the initial efficacy and safety data. The standard of care for the treatment of an impaired fracture, such as bone graft, typically involves highly invasive surgery which can be painful and requires months of rehabilitation with the risk of serious complications. Due to the risks of the current treatment, orthopaedic surgeons often take a ‘wait and see’ approach to the treatment of delayed-union fractures, sometimes for months, which delays the patient’s return to a normal life and leads to a significant burden on society. We are therefore thrilled that the judges at the Cells: Orthopedics conference 2015 have recognised the significance of the work we are doing in orthopaedics and with our allogeneic regenerative medicine approach."