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  Press Release 19 January 2015  

Bone Therapeutics Demonstrates Efficacy in First Patient Cohort in ALLOB® Phase I/IIA Delayed-Union Trial

Positive results in the first cohort of four patients treated with Bone Therapeutics’ novel allogeneic product for delayed-union fractures

Gosselies, Belgium, 19 January 2015 - BONE THERAPEUTICS, the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and fracture prevention, today announces positive efficacy results for the first cohort of four patients enrolled in the Phase I/IIA delayed-union trial with its allogeneic bone-forming cell product ALLOB®. Results from the initial four patients showed that all four ALLOB®-treated patients met the primary endpoints of the study and three patients have completely healed.
The ongoing Phase I/IIA study is a six month open-label trial to evaluate the safety and efficacy of ALLOB® in the treatment of delayed-union fractures of long bones. Today, the first cohort of four patients with a fracture that had not consolidated after a minimum of three and a maximum of seven months has been treated. Each patient received a single percutaneous administration of ALLOB® directly into the fracture site. Fracture healing of ALLOB®-treated patients is assessed in comparison to baseline at two weeks, one, three and six months using clinical (e.g., pain, weight bearing) and radiological evaluation. Treatment success will have been achieved when the health status of the patient has improved by at least 25% and the radiological score, as assessed by CT scan, has increased by at least two points versus baseline.
The fact that three out of the four treated delayed-union fractures have fully consolidated in such a short period of time demonstrates the strength of this product. Safety in the study was also recently confirmed by a Safety Monitoring Committee, which unanimously recommended the trial should progress as planned.

Commenting on today’s announcement, Enrico Bastianelli, CEO of Bone Therapeutics, said: “These results, coupled with the recent confirmation of safety in the trial, are very encouraging.  The radiological improvement confirms that the treatment is, so far, successful and confirms our belief that ALLOB® will offer significant benefit to patients. We are looking forward to progressing the trial to the next cohort of patients.”


For the French or Dutch version of this press release, please click on the links below:

Bone Therapeutics démontre l’efficacité d’ALLOB® sur le premier groupe de patients traités dans l’étude clinique de Phase I/IIA en Delayed-Union
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Bone Therapeutics toont doeltreffendheid aan van ALLOB® bij de eerste patiëntengroep in de Fase I/IIA studie voor vertraagd-helende breuken
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For further information, please contact:

Bone Therapeutics SA

Enrico Bastianelli, Chief Executive Officer
Wim Goemaere, Chief Financial Officer
Tel: +32 (0)2 529 59 90

Consilium Strategic Communications

Amber Bielecka, Mary-Jane Elliott,
Jessica Hodgson and Lindsey Neville
Tel: +44 (0) 20 3709 5708

NewCap Investor Relations & Financial Communications

Amber Bielecka, Mary-Jane Elliott,
Jessica Hodgson and Lindsey Neville
Tel: +44 (0) 20 3709 5708


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About ALLOB®

ALLOB® is a first-in-class allogeneic osteoblastic cell product with regenerative properties, developed for the treatment of bone diseases. "Allogeneic" means that the cells are harvested from a healthy, universal donor, as opposed to “autologous” where the cells come from the patient him/herself. ALLOB® is currently tested in two Phase I/IIa clinical trials for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine. ALLOB® has been classified as a tissue engineered product under the ATMP regulation 1394/2007EMA.

About Delayed-Union fractures

A delayed-union fracture is defined as a bone that has not healed within the expected normal period of time after the initial injury (i.e., 3 to 4 months) and is at risk of non-healing. Traditional options for the treatment of an impaired fracture (i.e., bone graft) typically involve highly invasive surgery, which can be painful and require months of rehabilitation with the risk of serious complications (such as deep bone infection). 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 several months, which delays the patient’s return to a normal life and leads to a significant financial burden to society. ALLOB® has the potential to become a first-line and early treatment for delayed-union fractures, thanks to its minimally invasive administration which avoids the need for major surgery.

About Bone Therapeutics

Bone Therapeutics is a leading biotechnology company specializing in the development of innovative regenerative therapies for the repair and prevention of bone fractures. The current standard of care in this field involves major surgeries and long recovery periods. To overcome these problems, Bone Therapeutics is developing a range of innovative products containing regenerative osteoblastic/bone-forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.
PREOB®, Bone Therapeutics’ autologous cell product, is currently in pivotal Phase III clinical studies for two indications: osteonecrosis and non-union fractures, and in Phase II for severe osteoporosis. ALLOB®, its allogeneic cell product, is in Phase II for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine. The Company also runs preclinical research programs and develops novel product candidates.
Founded in 2006, Bone Therapeutics is headquartered in Gosselies (South of Brussels, Belgium). Bone Therapeutics’ regenerative products are manufactured to the highest GMP standards and are protected by a rich IP estate covering 9 patent families.
Further information is available at

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Bone Therapeutics S.A. • Rue Adrienne Bolland, 8 • 6041 Gosselies • Belgium (Europe) • Phone: +32 (0) 2 529 59 90 • Fax: +32 (0) 2 529 59 93 •