Bone Therapeutics, an international biopharmaceutical company focused on innovative cell therapy products for the treatment of bone diseases, announced that its partner, the Rheumatology Department of Erasme University Hospital (Brussels, Belgium), has initiated a Phase IIa trial with its lead bone cell therapy product PREOB® for the treatment of severe osteoporosis patients who do not respond to pharmacological treatment.
PREOB® is Bone Therapeutics’ first-in-class autologous osteoblastic (bone forming) cell therapy product. Due to its unique mechanism of action, PREOB® could have a significant role to play in the treatment of severe osteoporosis, where the majority of current treatments do not provide bone forming/anabolic activity as their mechanism of action and where over 40% of patients under treatment are still losing bone mass and fracture PREOB® is currently in two pivotal Phase III trials for the treatment of osteonecrosis and non-union fractures.
This Phase IIa study is a six month open-label trial enrolling 20 patients with severe osteoporosis who do not respond to anti-osteoporotic treatment. PREOB® will be administered via a single intravenous infusion, and the primary endpoints of the trial will be cell body distribution and bone markers. The trial is the first of its kind to be initiated globally and will be run at the Erasme University Hospital (Free University of Brussels (ULB), Belgium).
Bone Therapeutics has been granted from the Free University of Brussels an exclusive worldwide license for PREOB® currently in Phase III clinical trials. Bone Therapeutics was founded in 2006 based on the pioneering works carried out at Erasme University Hospital-ULB, Brussels, Belgium. The Company still maintains close collaborations with scientific experts from various universities such as Prof. Gangji who is now head of the Rheumatology Department of the ULB Erasme Hospital.
Osteoporosis is a disease causing bone fragility and weakness and affects over 200 million people worldwide. Due to aging populations and growing awareness of the disease, the global market for osteoporosis therapeutics is expected to reach $8.8 billion in 2015.
Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics, commented: “We are delighted to be expanding the potential of our lead product PREOB® to osteoporosis, a large disease area with significant unmet need, under the existing agreement that we have with the Free University of Brussels.”
Valérie Gangji, Head of Rheumatology, Erasme University Hospital commented: “We are very excited to be investigating the potential of PREOB® in treatment-resistant osteoporosis, where PREOB®’s unique mechanism of action could have a real impact on patients. A new treatment such as PREOB® that could reduce the risk of fracture and the formation of new bone could significantly improve the quality of life of these osteoporotic patients.”
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