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, today announces that it has treated the first patients suffering from a failed spinal fusion with its unique allogeneic bone cell therapy product ALLOB®.
This is the first trial involving the administration of a bone cell therapy product percutaneously directly into the failed fusion area without an open procedure. The implantation of bone cells is intended to promote the fusion process through stimulation of bone formation. This study complements the key Phase IIA ALLOB® spinal fusion trial that was initiated last year.
Spinal fusion surgery is routine, with around one million procedures performed each year in Europe and the US. For the lumbar spine, which accounts for half a million fusion procedures each year, non-union and failure to relieve lower back pain are still frequent outcomes. It is estimated that up to one quarter of spinal fusion procedures are unsuccessful1. Standard of care revision procedures require open surgery and are associated with several factors that present more difficulties than the initial surgery, consequently increasing the risk of complications2. For example, fibrosis and scarring make revision surgery significantly more difficult and vascular supply may be compromised3. Bone Therapeutics’ rescue procedure is designed to be safer and easier compared to the existing procedures.
The study is a pilot, open, proof-of-concept Phase IIA trial to evaluate the safety and the efficacy of ALLOB® implantation in rescue spinal fusion over 12 months. Sixteen patients diagnosed with a failed lumbar spinal fusion at 15 months or more following the initial surgery, and requiring a rescue surgery, will be treated with a single percutaneous implantation of ALLOB® cells into the failed fusion area. The process is monitored by fluoroscopy to visualize and optimize the exact location of administration. The efficacy of the treatment will be evaluated clinically and radiologically by CT-scan.
Enrico Bastianelli, CEO of Bone Therapeutics, commented: “We are delighted to start this pioneering rescue spinal fusion trial alongside the two other Phase II trials for ALLOB® that were initiated last year. With this trial we are aiming to offer a safe and minimally invasive treatment option to patients who are suffering from a failed spinal fusion. The trial is a key pillar of Bone Therapeutics’ strategy, outlined at the time of the IPO, to leverage our unique bone cell platform, accelerate Phase II clinical trials specifically in spinal fusion procedures and further develop an advanced and diversified product pipeline.”
1Nguyen et al. Epidemiology. 2011 (36)320-331; Aghion et al. Med Health R I. 2012 (95)391-393. 2Ma et al. Spine J. 2010 (10)881-9. 3Eichholz et al. Neurosurg Focus. 2003 (15)3
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 I/IIA 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 11 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 SA
Enrico Bastianelli, +32 (0)2 529 59 90
Chief Executive Officer
Wim Goemaere, Chief Financial Officer
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