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  Press Release 2 March 2015  
 
 
 

Bone Therapeutics accelerates its ALLOB® Phase I/IIA Delayed-Union trial

Trial now approved in the UK and extension to France initiated

Gosselies, Belgium, 2 March 2015 - BONE THERAPEUTICS, the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, today announces that the Competent Authorities and Central Ethics Committee in the UK have granted Bone Therapeutics authorisation to extend its Phase I/IIA trial for its cell therapy product ALLOB® in the UK, while the first steps have been taken to receive approval for the trial in France. ALLOB® is Bone Therapeutics’ allogeneic, osteoblastic cell therapy product for the treatment of delayed-union fractures.

The approval to extend the trial in the UK will allow the addition of two new sites, the prestigious King’s College Hospital in London and Norfolk and Norwich University Hospitals NHS Foundation Trust. A total of 14 centres across Belgium, Germany and the UK have now received authorization to enrol patients into the Phase I/IIA delayed-union trial. In France, a total of 4 centres is considered. Together, this will ensure coverage of all large European countries.

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. Patients receive a single percutaneous administration of ALLOB® directly into the fracture site, after which fracture healing is assessed and compared to baseline by clinical and radiological evaluation at two weeks, one, three and six months. Data gathered from the first cohort of four patients have already demonstrated excellent safety and efficacy.

Enrico Bastianelli, CEO of Bone Therapeutics commented: "As announced at the time of our recent successful IPO, the extension to the UK and France will accelerate the recruitment of patients into the ALLOB® delayed-union trial. The approval demonstrates the interest in, and need for, our allogeneic product, ALLOB®, in the management of delayed-union fractures where, due to the risk involved with current treatment options, surgeons often take a wait and see approach. Thanks to its minimally invasive administration, ALLOB® has the potential to become a first-line treatment for delayed-union fractures and we look forward to updating the market with further details on this trial in due course."
 

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To read this press release in French or Dutch, please follow the link below:
FR - NL

 
 

 
 

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
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:

Consilium Strategic Communications

Amber Bielecka, Mary-Jane Elliott,
Jessica Hodgson and Lindsey Neville
Tel: +44 (0) 20 3709 5708
bonetherapeutics@consilium-comms.com
 

For French Media and Investor Enquiries:

NewCap Investor Relations

Pierre Laurent and Antoine Denry
Tel: + 33 (0)1 44 71 94 94
bone@newcap.fr

 

 
 

 
 
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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-Unions

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 cell therapy products intended for bone fracture repair and fracture prevention. 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 regenerative products containing osteoblastic/bone-forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.
PREOB®, Bone Therapeutics’ autologous bone cell product, is currently in pivotal Phase IIB/III clinical studies for two indications: osteonecrosis and non-union fractures, and in Phase II for severe osteoporosis. ALLOB®, its allogeneic “off-the-shelf” bone 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: www.bonetherapeutics.com.


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 • www.bonetherapeutics.com