Bone Therapeutics Treats Second Patient Cohort in ALLOB® Phase I/IIA Delayed-Union Fracture Trial

Actualité publiée le 07/09/15 07:00

Regulatory News:

BONE THERAPEUTICS (Brussels:BOTHE) (Paris:BOTHE)(Euronext Brussels and 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 it has completed treatment without any safety concerns of the second cohort of patients in the ALLOB^® Phase I/IIA trial for patients with delayed-union fractures.

The Safety Monitoring Committee, composed of medical experts, met to review the initial safety data of the two cohorts and following analysis of clinical, laboratory and biological parameters, the committee unanimously agreed that the trial can proceed as planned and can continue to enrol patients.

Enrico Bastianelli, CEO of Bone Therapeutics, commented:“This is the first trial in which our allogeneic¹ bone cell therapy product is being evaluated and we are pleased to have reached this important patient treatment milestone without any safety issues. We were very encouraged with the positive efficacy results previously reported from the first cohort of patients in the trial and we look forward to updating the market on the efficacy of this second patient cohort.”

The ongoing Phase I/IIA study is a six-month open-label trial to evaluate the safety and efficacy of Bone Therapeutics’ allogeneic bone cell therapy product, ALLOB^®, in the treatment of delayed-union fractures of long bones. The study is targeting the recruitment of 32 patients, but is flexible and could be prematurely stopped due to efficacy after an interim data analysis of the 16 first patients. To date, eight patients with a fracture that had failed to consolidate after a minimum of three and a maximum of seven months, have received a single percutaneous administration of ALLOB^® directly into the fracture site. Fracture healing of ALLOB^®-treated patients is assessed using clinical (e.g., pain, weight bearing) and radiological evaluation.

One patient of the second cohort has also been included in a sub-study to investigate the biodistribution of the ALLOB^® cells through the body and to confirm their presence at the fracture site after administration. By radioactively labelling a fraction of the ALLOB^® cells before injection, the cells can be traced up to 72 hours after administration using SPECT scans². Results from this sub-study are an important support for future efficacy results, as the continued gathering of the cells at the fracture site is important for the therapy to have an optimal effect.

¹ Where cells are derived from a healthy donor, rather than the patient.

² A SPECT (Single Photon Emission Computed Tomography) scan visualizes the radioactive label attached to the cells in order to determine their location in the body. This is combined with a CT scan, that visualizes anatomical structures using x-ray, to allow specification of the exact location.

-Ends-

About BoneTherapeutics

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) and is listed on Euronext Brussels under the ticker BOTHE. 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.