Bone Therapeutics Starts Patient Treatment in First Ever Clinical Trial with Allogeneic Bone Cell Therapy Product

GOSSELIES, Belgium, June 25, 2014 /PRNewswire/ --

Minimally invasive bone forming product ALLOBin Phase I/IIa trial for delayed union fracture

Bone Therapeutics, the regenerative therapy company addressing unmet medical needs in the field of bone diseases and orthopaedics, today announces that the first patient has been treated with its novel allogeneic osteoblastic (bone-forming) cell therapy product ALLOB in its phase I/IIa study for the treatment of delayed union fractures.

ALLOB is the first ever allogeneic differentiated[1] osteoblastic cell therapy product developed for the treatment of orthopaedic conditions. Allogeneic cell therapy involves the harvesting of cells from a healthy, universal donor, rather than from the patient being treated. ALLOB has shown safety and efficacy in preclinical studies and does not require any immunosuppressive side therapy.

ALLOB has the potential to become a first-line treatment for impaired fracture healing, thanks to its minimally invasive percutaneous administration. Delayed union fractures, defined by the absence of fracture healing after 3 months, affect around 600,000 to 900,000 new patients a year in Europe and the US. The current standard of care for delayed union fractures involves highly invasive surgery, which takes up to several hours followed by a long hospitalization. By contrast, this first administration of ALLOB required about 20 minutes and took place at the day-clinic. ALLOB is injected by the orthopaedic surgeon in a single dose percutaneously, directly into the fracture site. No side-effects have yet been reported.

This first-in-human, proof-of-concept, 6 months open-label phase I/IIa study is evaluating the safety and efficacy of ALLOB in the treatment of delayed union fractures of long bones. ALLOB-treated patients will be assessed in comparison to baseline at 2 weeks, 1, 3 and 6 months using clinical (e.g., pain, weight-bearing) and radiological evaluation. Ultimately, 32 patients with delayed union fractures will be enrolled in the study.

Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics commented: "Treating a patient for the first time with our allogeneic product ALLOB is a significant step forward for the progression of Bone Therapeutics' regenerative therapy pipeline. Our allogeneic approach will lead to an "off-the-shelf" approach to treatment whilst offering delayed union patients the potential for a significant improvement in their condition without the need for invasive surgery. ALLOB has the potential to add significant shareholder value as it could address multiple orthopaedic conditions as a first line treatment. This first in human trial is an important milestone both for realizing benefits for the patients as well as creating value for the Company."

About ALLOB

ALLOBis Bone Therapeutics' allogeneic bone cell therapy product. "Allogeneic" means that the cells are harvested[2]from a healthy, universal donor, rather than from the patient him/herself (autologous). Currently in a Phase I/IIa clinical trial for delayed union fractures, ALLOBalso has the potential to be applied for treating other orthopaedic conditions as well as for systemic applications such as in osteogenesis imperfecta, a rare genetic bone disease characterized by bone fragility and fractures. ALLOBhas been classified as a tissue engineered product under the ATMP regulation 1394/2007EMA.

About Delayed Union Fractures

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Bone Therapeutics Starts Patient Treatment in First Ever Clinical Trial with Allogeneic Bone Cell Therapy Product