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  Press Release December 2014  

Bone Therapeutics Authorised to Enrol Patients in the UK in Pivotal Phase III Osteonecrosis Trial with PREOB®

Five UK centres now approved to test the novel regenerative therapy

Gosselies, Belgium, 4 December 2014 - BONE THERAPEUTICS, the regenerative therapy company addressing unmet medical needs in the field of bone fracture repair and fracture prevention, today announces that it has received authorisation from the Competent Authorities and Central Ethics Committee to enrol patients in the UK into its pivotal Phase III trial to confirm the safety and efficacy of its regenerative therapy product PREOB® in the treatment of osteonecrosis (also known as avascular necrosis, AVN).

Five UK sites, including Cambridge University Hospitals, King’s College Hospital London, Newcastle University/Newcastle upon Tyne Hospitals, University Hospital Southampton and The Royal Orthopaedic Hospital Birmingham are now approved.  A total of 37 centres across the UK, Belgium, Germany, France and The Netherlands have received authorization to conduct the Phase III trial of PREOB®, which has orphan drug status in Europe and the USA.
Osteonecrosis is a bone disease characterised by the death of bone tissue, eventually causing the bone to collapse. Osteonecrosis is most common in the hip where the disease causes femoral head collapse and joint destruction, leading to the requirement of a hip prosthesis. About 150,000 patients require total hip replacement due to osteonecrosis each year in Europe and the USA. As the condition typically affects younger people (ages 30 to 50), for whom hip replacement is not an appropriate long-term solution due to the rather limited lifespan of prostheses, the area is in need of a novel approach. Bone Therapeutics will be working closely with the AVN charity UK to raise awareness of this debilitating condition*.
The phase III study is a randomized, double-blind, placebo-controlled pivotal trial that aims to confirm the safety and efficacy of Bone Therapeutics’ autologous osteoblastic or bone-forming cell product, PREOB®, in early-stage osteonecrosis of the femoral head over a 24-month period in 130 patients. PREOB® is designed as a first-line treatment as it is administered via a minimally invasive approach directly into the necrotic lesion, thereby avoiding the need for open surgery.
Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics commented, “We are delighted to have extended this pivotal study to the UK and to be working with such prestigious UK institutions. It is an important step in the acceleration of this key study which could see PREOB® as a first line treatment in this painful and debilitating disorder.”
Edith Brown, Co-Trustee of the AVN Charity UK commented, “Osteonecrosis is a severely debilitating disease and due to the young age of many patients, sufferers often have to face years of pain until they are deemed old enough for total hip replacement.  A regenerative treatment that could avoid the need for surgery and give long lasting effects from diagnosis would change the lives of so many sufferers and we look forward to the results of this pivotal study.”

*For more information on the AVN Charity UK, please visit:

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For further information, please contact:

Bone Therapeutics SA

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

Consilium Strategic Communications

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


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About PREOB®

Bone Therapeutics’ PREOB® is a first-in-class autologous osteoblastic cell product administered percutaneously via a minimally invasive approach, avoiding the need for open surgery. Based on the promising results of the proof-of-concept Phase II studies, which have shown statistically significant and clinically relevant benefits, PREOB® is currently in two pivotal trials in Europe: a Phase III trial in the treatment of hip osteonecrosis and a Phase IIb/III trial in the treatment of long bone non-union fractures. PREOB® also entered a Phase I/IIa clinical trial for the treatment of severe osteoporosis.

About Bone Therapeutics

Bone Therapeutics is a leading biotechnology company specializing in the development of innovative regenerative therapies for the treatment of orthopaedic conditions. 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 treatment-resistant 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 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 •