Bone Therapeutics: ALLOB® Delayed-Union Program Awarded at Cells Orthopedics Conference

Peer review panel praises scientific value and medical relevance of ALLOB® Phase I/IIA in delayed-union fractures

GOSSELIES, Belgium--()--Regulatory News:

BONE THERAPEUTICS (Brussels:BOTHE) (Paris:BOTHE), the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, announces that it has been awarded a gold prize for an abstract on the Phase I/IIA trial of its ALLOB® allogeneic cell therapy in delayed-union fractures of long bones.

The abstract, “A pilot Phase I/IIA, multicentre, open proof-of-concept study on the efficacy and safety of allogeneic osteoblastic cells (ALLOB®) implantation in non-infected delayed-union fractures” by Elisa Llinares, PhD, Audrey Colliou, PharmD and Enrico Bastianelli, MD, MBA, was awarded the top prize on December 4th, following the Cells: Orthopedics conference 2015 in Palma Mallorca, Spain, held November 13th – 15th. The abstract beats other contestants to be recognised by the Clinical and Scientific Advisory Board of the conference based on scientific or clinical value, originality, categorical relevance and overall presentation and conclusion. The poster can be accessed here: http://rgnmed.com/gold-winner-osteoblastic-cell-based-therapy-for-delayed-union-fractures/.

The poster outlines the Company’s unique approach to the development of cell therapy products for bone fracture repair and prevention, details findings from preclinical studies on Bone Therapeutics’ bone formation model and outlines the parameters of the ongoing Phase I/IIA study of ALLOB® in delayed-union fractures.

This Phase I/IIA trial is a six-month, open-label trial for the treatment of delayed-union fractures of long bones. The Company recently reported excellent safety and efficacy from the treatment of the initial four patients and has successfully treated a second cohort of patients without any safety issues. The trial is targeting the recruitment of 32 patients in Belgium, Germany and the UK but is flexible and could be stopped earlier if efficacy is seen following an interim data analysis of the first 16 patients. The poster presented outlined preclinical findings before updating on the progress of the Phase I/IIA trial.

Enrico Bastianelli, CEO of Bone Therapeutics, commented: “This is the first trial to investigate an allogeneic bone cell therapy product, and we are very enthusiastic about the initial efficacy and safety data. The standard of care for the treatment of an impaired fracture, such as bone graft, typically involves highly invasive surgery which can be painful and requires months of rehabilitation with the risk of serious complications. 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 months, which delays the patient’s return to a normal life and leads to a significant burden on society. We are therefore thrilled that the judges at the Cells: Orthopedics conference 2015 have recognised the significance of the work we are doing in orthopaedics and with our allogeneic regenerative medicine approach.”

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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 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.

Contacts

For more information, please contact:
Bone Therapeutics SA
Enrico Bastianelli, Chief Executive Officer/ Wim Goemaere, Chief Financial Officer, +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com
or
For Belgium and International Media Enquiries
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville, +44 (0) 20 3709 5700
bonetherapeutics@consilium-comms.com
or
For French Media and Investor Enquiries
NewCap Investor Relations & Financial Communications
Pierre Laurent and Antoine Denry, + 33 (0)1 44 71 94 94
bone@newcap.fr

Contacts

For more information, please contact:
Bone Therapeutics SA
Enrico Bastianelli, Chief Executive Officer/ Wim Goemaere, Chief Financial Officer, +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com
or
For Belgium and International Media Enquiries
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville, +44 (0) 20 3709 5700
bonetherapeutics@consilium-comms.com
or
For French Media and Investor Enquiries
NewCap Investor Relations & Financial Communications
Pierre Laurent and Antoine Denry, + 33 (0)1 44 71 94 94
bone@newcap.fr