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 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) 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.
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