Gosselies, Belgium, 23 March 2015 - BONE THERAPEUTICS, the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, today announces that the first four patients in the phase IIA proof-of-concept study for spinal fusion procedures have been treated with Bone Therapeutics’ allogeneic osteoblastic (bone-forming) cell therapy product, ALLOB®.
This pilot Phase IIA study will enrol 16 patients with symptomatic degenerative lumbar disc disease who require interbody fusion surgery[1]. Patients will be treated with a single dose of ALLOB® combined with bioceramic granules to achieve bone formation and fusion of the vertebral bodies. Safety and efficacy of this treatment will be assessed over 12 months, using clinical and radiological evaluation. Spinal fusion is a procedure that eliminates pain and restores the normal life of a patient but, despite being a fairly routine surgery, is often associated with high failure rates. Bone Therapeutics’ cell therapy product has been designed to accelerate the fusion process and reduce the failure rate of current surgeries.
Today, the procedure has been performed in four patients without any complications or safety issues. The trial is currently running in four centres across Belgium: the Erasmus Hospital in Brussels, the University Hospital of Charleroi, Brugmann University Hospital in Brussels and the Hospital Oost-Limburg in Genk.
ALLOB® is also currently being studied in a Phase I/IIA trial for the treatment of delayed-union fractures and recently reported excellent safety and efficacy from the treatment of the initial four patients.
Enrico Bastianelli, CEO of Bone Therapeutics, commented: “The treatment of the first four patients in the ALLOB® spinal fusion trial represents a significant step forward in the development of our clinical program. With our unique approach, combining granules with our allogeneic cell therapy product, we aim to reduce the number of failed spinal fusions and revision surgeries and improve quality of life for patients.”
-Ends-
About ALLOB®
ALLOB® is a first-in-class allogeneic osteoblastic cell product with regenerative properties, developed for the treatment of bone diseases. "Allogeneic" means that the cells are harvested from a healthy, universal donor, as opposed to “autologous” where the cells come from the patient him/herself. ALLOB® is currently tested in two Phase I/IIa clinical trials for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine. ALLOB® has been classified as a tissue engineered product under the ATMP regulation 1394/2007EMA.
About spinal fusion
Spinal fusion is considered as the gold standard surgery for treating a broad spectrum of degenerative spine disorders, including degenerative disc disease to relieve pain and improve function. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft, for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Despite the fact that spinal fusion surgery is routine, non-union and failure to relieve lower back pain are unfortunately still frequent as up to 25 to 30% of spinal fusion patients are not completely satisfied with their surgery. Bone autograft is perceived as the gold-standard for spinal fusion procedures, despite high safety concerns (in particular donor site pain). Bone Therapeutics' products are intended to decrease the failure rate of spinal fusion surgeries.
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 II 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 9 patent families. Further information is available at www.bonetherapeutics.com.
For more information, please contact:
Bone Therapeutics SA Tel: +32 (0)2 529 59 90
Enrico Bastianelli, Chief Executive Officer/ Wim Goemaere, Chief Financial Officer
investorrelations@bonetherapeutics.com
For Belgium and International Media Enquiries
Consilium Strategic Communications
Amber Bielecka, Mary-Jane Elliott, Jessica Hodgson and Lindsey Neville
Tel: +44 (0) 20 3709 5700
bonetherapeutics@consilium-comms.com
For French Media and Investor Enquiries
NewCap Investor Relations & Financial Communications
Pierre Laurent and Antoine Denry
Tel: + 33 (0)1 44 71 94 94
bone@newcap.fr
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This pilot Phase IIA study will enrol 16 patients with symptomatic degenerative lumbar disc disease who require interbody fusion surgery[1]. Patients will be treated with a single dose of ALLOB® combined with bioceramic granules to achieve bone formation and fusion of the vertebral bodies. Safety and efficacy of this treatment will be assessed over 12 months, using clinical and radiological evaluation. Spinal fusion is a procedure that eliminates pain and restores the normal life of a patient but, despite being a fairly routine surgery, is often associated with high failure rates. Bone Therapeutics’ cell therapy product has been designed to accelerate the fusion process and reduce the failure rate of current surgeries.
Today, the procedure has been performed in four patients without any complications or safety issues. The trial is currently running in four centres across Belgium: the Erasmus Hospital in Brussels, the University Hospital of Charleroi, Brugmann University Hospital in Brussels and the Hospital Oost-Limburg in Genk.
ALLOB® is also currently being studied in a Phase I/IIA trial for the treatment of delayed-union fractures and recently reported excellent safety and efficacy from the treatment of the initial four patients.
Enrico Bastianelli, CEO of Bone Therapeutics, commented: “The treatment of the first four patients in the ALLOB® spinal fusion trial represents a significant step forward in the development of our clinical program. With our unique approach, combining granules with our allogeneic cell therapy product, we aim to reduce the number of failed spinal fusions and revision surgeries and improve quality of life for patients.”
-Ends-
About ALLOB®
ALLOB® is a first-in-class allogeneic osteoblastic cell product with regenerative properties, developed for the treatment of bone diseases. "Allogeneic" means that the cells are harvested from a healthy, universal donor, as opposed to “autologous” where the cells come from the patient him/herself. ALLOB® is currently tested in two Phase I/IIa clinical trials for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine. ALLOB® has been classified as a tissue engineered product under the ATMP regulation 1394/2007EMA.
About spinal fusion
Spinal fusion is considered as the gold standard surgery for treating a broad spectrum of degenerative spine disorders, including degenerative disc disease to relieve pain and improve function. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft, for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Despite the fact that spinal fusion surgery is routine, non-union and failure to relieve lower back pain are unfortunately still frequent as up to 25 to 30% of spinal fusion patients are not completely satisfied with their surgery. Bone autograft is perceived as the gold-standard for spinal fusion procedures, despite high safety concerns (in particular donor site pain). Bone Therapeutics' products are intended to decrease the failure rate of spinal fusion surgeries.
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 II 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 9 patent families. Further information is available at www.bonetherapeutics.com.
For more information, please contact:
Bone Therapeutics SA Tel: +32 (0)2 529 59 90
Enrico Bastianelli, Chief Executive Officer/ Wim Goemaere, Chief Financial Officer
investorrelations@bonetherapeutics.com
For Belgium and International Media Enquiries
Consilium Strategic Communications
Amber Bielecka, Mary-Jane Elliott, Jessica Hodgson and Lindsey Neville
Tel: +44 (0) 20 3709 5700
bonetherapeutics@consilium-comms.com
For French Media and Investor Enquiries
NewCap Investor Relations & Financial Communications
Pierre Laurent and Antoine Denry
Tel: + 33 (0)1 44 71 94 94
bone@newcap.fr
Help employers find you! Check out all the jobs and post your resume.
