Updated on 6 December 2013
Singapore: Europe based Bone Therapeutics, a regenerative therapy company, has received clearance from the Competent Authorities in Belgium, France and the Netherlands to initiate a phase IIb/III trial with its autologous cell therapy product, PREOB, for the treatment of non-union fractures.
PREOB is a first-in-class autologous osteoblastic/bone forming cell product. It is positioned as a first-line treatment for non-union fractures as it is administered via a minimally invasive approach directly into the fracture site, thereby avoiding the need for open surgery.
Non-union is a serious fracture complication where the normal process of bone healing is interrupted. In general, if a fracture is still evident at six months post injury, it will remain unhealed without specific treatment. Current standard of care involves invasive surgeries with a high risk of complications.
PREOB is also being evaluated in an ongoing Phase III trial for the treatment of osteonecrosis.
Enrico Bastianelli, CEO of Bone Therapeutics commented, "We are delighted to have started this pivotal trial of PREOB® for the treatment of non-union fractures, an area of significant unmet medical need. For Bone Therapeutics' to have two pivotal phase IIb/III trials running simultaneously is quite an achievement. Alongside our allogeneic product pipeline, today's trial start further strengthens our position as a regenerative therapies leader in the field of orthopaedics."