Bone Therapeutics Cleared to Test ALLOB in Spinal Fusion Trial


Bone Therapeutics is a biotechnology company that specializes in regenerative therapies for orthopaedic conditions. Founded in 2006, Bone Therapeutics is headquartered in Gosselies, Belgium. One of the products developed by Bone Therapeutics is called ALLOB, which is a bone making (osteoblastic) cell product that has the ability to regenerate bone, and has been developed for the treatment of bone diseases. ALLOB is meant to be an off-the-shelf product that can be used to treat patients with various types of bone diseases.

Bone Therapeutics has recently announced that it has received approval from the Belgium regulatory agencies for a phase II proof-of-concept study to assess the safety and efficacy of ALLOB in spinal fusion procedures that are commonly used to treat degenerative lumbar disc disease. The hope is that this clinical trial will demonstrate that ALLOB improves spinal fusion surgery outcomes. Bone Therapeutics hopes to market ALLOB as an off-the-shelf treatment for spinal fusion surgery.

In previous studies, ALLOB has shown that it can enhance bone formation, and that it is a safe product in laboratory animals. Currently ALLOB is being evaluated in a phase I/IIa trial for delayed-union fractures. This is a pilot proof-of-concept study that examines 16 patients with symptomatic degenerative lumbar disc disease, all of whom require interbody vertebral fusion. These patients will be treated with a single dose of ALLOB mixed with bioceramic granules to promote bone formation and fusion at the within the degenerative discs. The bioceramic scaffold in this trials promotes bone formation by guiding bone growth in three dimensions and restoring a healthy bone environment. Patients will be enrolled in this trial at four different centres. The safety and efficacy of the treatment will be monitored over 12 months by clinical and radiological means. Additionally, there will be a 24-month post-study follow-up.

Back pain is a widespread medical disorder in industrialized societies that sometimes requires spinal surgery. Around 1.3 million spinal fusions are performed each year in Europe and the USA, the majority of which are to address degenerative lumbar disc disease. Despite the frequency of this surgery, non-union of bone and persistent pain following the intervention is still somewhat common. Further improvements to this procedure would be most welcome to patients and medical practitioners alike.

Enrico Bastianelli, CEO of Bone Therapeutics commented, “This new clinical trial clearance from the Competent Authorities in Belgium is an important milestone in the development of ALLOB® and further validates Bone Therapeutics’ clinical, regulatory and manufacturing capabilities.”

Advertisements

Published by

mburatov

Professor of Biochemistry at Spring Arbor University (SAU) in Spring Arbor, MI. Have been at SAU since 1999. Author of The Stem Cell Epistles. Before that I was a postdoctoral research fellow at the University of Pennsylvania in Philadelphia, PA (1997-1999), and Sussex University, Falmer, UK (1994-1997). I studied Cell and Developmental Biology at UC Irvine (PhD 1994), and Microbiology at UC Davis (MA 1986, BS 1984).