In spine fusion, Bone Therapeutics is investigating a unique approach where an interbody cage is implanted in-between the damaged vertebrae according to the standard-of-care surgical approach and supplemented with Allob in combination with bioceramic granules. Preclinical results demonstrated that the combination of bioceramics with Allob cells significantly increased fusion in comparison with bioceramics alone. Safety and efficacy of the implantation of Allob cells mixed with bioceramic granules in lumbar spinal fusion is evaluated in this Phase IIA study using clinical and radiological parameters at 6 and 12 months after treatment. In total, of the 18 patients enrolled in the study, 16 were eligible and 15 have been treated*. No treatment-related safety concerns were reported. It is expected that efficacy data from the first four patients from the study will be reported by the end of the second quarter of 2016 with the complete set of efficacy results expected in the second quarter of 2017.
In addition to high clinical demand, the extension has been designed to study the detailed dynamics of the fusion. In the extension trial, 16 patients will be treated and evaluated earlier with review of the patient’s progress after 3, 6 and 12 months.
“We are very happy with the rate at which this trial has progressed, said CEO Enrico Bastianelli. “With the spinal fusion program we intend to improve the current surgical procedure and increase its chance of success. The large unmet need of this indication, alongside evidence of fusion earlier than anticipated, have led us to extend the trial. We look forward to communicating on the next efficacy results of this promising trial.”
One out of the 16 eligible patients was not treated as the surgeon decided to change the surgical procedure.
Allob is a first-in-class allogeneic differentiated osteoblastic (bone-forming) cell therapy product developed for the treatment of orthopedic conditions and bone diseases. Allogeneic cell therapy involves the harvesting of cells from a healthy donor, rather than from the treated patient. Allob is currently being evaluated in three Phase I/IIA clinical trials for delayed-union fractures, spinal fusion and the revision of failed spinal fusions. It has been classified as a tissue engineered product and received orphan drug designation from regulatory authorities in Europe and the united States for two indications: osteonecrosis and osteogenesis imperfecta.
Spinal fusion is considered the gold standard surgery for treating a broad spectrum of degenerative spine disorders, including degenerative disc disease to relieve pain and improve function. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft, for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Despite the fact that spinal fusion surgery is routine, non-union and failure to relieve lower back pain are unfortunately still frequent as up to 25 to 30 percent of spinal fusion patients are not completely satisfied with their surgery. Bone Therapeutics' products are intended to decrease the failure rate of spinal fusion surgeries.
Bone Therapeutics is a biotechnology company specializing in the development of cell therapy products intended for bone fracture repair and fracture prevention.