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Bone Therapeutics Starts Patient Treatment in First Ever Clinical Trial with Allogeneic Bone Cell Therapy Product

June 25, 2014

GOSSELIES, Belgium, June 25, 2014 /PRNewswire/ –

Minimally invasive bone forming product ALLOB(R)in Phase I/IIa trial for

delayed union fracture

Bone Therapeutics, the regenerative therapy company addressing unmet medical needs in
the field of bone diseases and orthopaedics, today announces that the first patient has
been treated with its novel allogeneic osteoblastic (bone-forming) cell therapy product
ALLOB(R) in its phase I/IIa study for the treatment of delayed union fractures.

ALLOB(R) is the first ever allogeneic differentiated[1] osteoblastic cell therapy
product developed for the treatment of orthopaedic conditions. Allogeneic cell therapy
involves the harvesting of cells from a healthy, universal donor, rather than from the
patient being treated. ALLOB(R) has shown safety and efficacy in preclinical studies and
does not require any immunosuppressive side therapy.

ALLOB(R) has the potential to become a first-line treatment for impaired fracture
healing, thanks to its minimally invasive percutaneous administration. Delayed union
fractures, defined by the absence of fracture healing after 3 months, affect around
600,000 to 900,000 new patients a year in Europe and the US. The current standard of care
for delayed union fractures involves highly invasive surgery, which takes up to several
hours followed by a long hospitalization. By contrast, this first administration of
ALLOB(R) required about 20 minutes and took place at the day-clinic. ALLOB(R) is injected
by the orthopaedic surgeon in a single dose percutaneously, directly into the fracture
site. No side-effects have yet been reported.

This first-in-human, proof-of-concept, 6 months open-label phase I/IIa study is
evaluating the safety and efficacy of ALLOB(R) in the treatment of delayed union fractures
of long bones. ALLOB(R)-treated patients will be assessed in comparison to baseline at 2
weeks, 1, 3 and 6 months using clinical (e.g., pain, weight-bearing) and radiological
evaluation. Ultimately, 32 patients with delayed union fractures will be enrolled in the
study.

Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics commented: “Treating
a patient for the first time with our allogeneic product ALLOB(R) is a significant step
forward for the progression of Bone Therapeutics’ regenerative therapy pipeline. Our
allogeneic approach will lead to an “off-the-shelf” approach to treatment whilst offering
delayed union patients the potential for a significant improvement in their condition
without the need for invasive surgery. ALLOB(R) has the potential to add significant
shareholder value as it could address multiple orthopaedic conditions as a first line
treatment. This first in human trial is an important milestone both for realizing benefits
for the patients as well as creating value for the Company.”

About ALLOB(R)

ALLOB(R) is Bone Therapeutics’ allogeneic bone cell therapy product. “Allogeneic”
means that the cells are harvested[2] from a healthy, universal donor, rather than from
the patient him/herself (autologous). Currently in a Phase I/IIa clinical trial for
delayed union fractures, ALLOB(R) also has the potential to be applied for treating other
orthopaedic conditions as well as for systemic applications such as in osteogenesis
imperfecta, a rare genetic bone disease characterized by bone fragility and fractures.
ALLOB(R) has been classified as a tissue engineered product under the ATMP regulation
1394/2007EMA.

About Delayed Union Fractures

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. Around 600,000 to 900,000 patients are affected by delayed union each year.
Traditional options for the treatment of impaired fracture healing typically involve
highly invasive surgery, which can be painful and require months of rehabilitation with no
guarantee of success.

About Bone Therapeutics

Bone Therapeutics is a regenerative therapy company specializing in addressing unmet
medical needs in the field of orthopaedics via a minimally invasive approach. Utilizing
the Company’s unique knowledge of the bone/joint physiology and long-standing expertise in
cell therapy and cell transplantation, Bone Therapeutics has created a fully integrated
business with an advanced product pipeline comprising novel bone cell products, tailored
in-house production methods and minimally invasive treatment techniques.

Bone Therapeutics autologous bone cell product, PREOB(R), is currently in phase III
clinical trials for the treatment of osteonecrosis and non-union fractures. Bone
Therapeutics is also developing an allogeneic bone cell therapy product, ALLOB(R), which
entered the clinic in 2014 for the treatment of delayed union fractures. All of Bone
Therapeutics’ cell therapy products are manufactured to the highest GMP standards, comply
with all regulations and are protected by a rich IP estate.

The bone disease and reconstruction market is one of the largest healthcare markets in
the world, with more than 4 million procedures requiring bone grafts performed annually in
Europe and the USA alone. Bone Therapeutics is operating in areas where demand for new
products is high and competition is low. Founded in 2006, Bone Therapeutics is privately
held and headquartered in Gosselies (south of Brussels), Belgium. Further information is
available at: http://www.bonetherapeutics.com

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1. differentiated osteoblastic cells showing higher efficacy compared to
undifferentiated stem cells – Undale – JOR December 2011

2. Recent literature (Ruetze and Richter, 2014) indicates that bone marrow derived
cells perform considerably better than adipose derived mesenchymal stem cells

        Bone Therapeutics SA
        Tel: +32-(0)2-529-59-90
        Enrico Bastianelli, Chief Executive Officer
        Wim Goemaere, Chief Financial Officer
        info@bonetherapeutics.com

        Consilium Strategic Communications
        Amber Bielecka, Mary-Jane
        Elliott, Lindsey Neville, Jessica Hodgson
        Tel: +44-(0)20-3-709-5700
        bonetherapeutics@consiliumcomms.com
        Follow us: LinkedIn [http://www.linkedin.com/company/bone-therapeutics-s-a- ], Facebook
         [https://www.facebook.com/BoneTherapeutics ], Twitter
         [https://twitter.com/BoneTherapeutic ]

SOURCE Bone Therapeutics


Source: PR Newswire



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