Efficacy and safety results expected in mid-2019
Promising interim efficacy and safety data already reported
GOSSELIES, Belgium I February 19, 2018 I BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that it has completed the recruitment of its Phase IIA lumbar spinal fusion study with its allogeneic bone-cell therapy product, ALLOB®. Given this timing, efficacy and safety data for the full set of 32 patients are expected mid-2019, following a follow-up period of 12 months.
Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “We are pleased to announce recruitment of the last patient into our Phase IIA spinal fusion study with ALLOB®, on schedule. Our promising interim results showed bone formation in ALLOB®-treated patients, who also reported significant improvement in pain and day to day functional abilities. We look forward to reporting the full data set in mid-2019 as further positive results would continue to confirm the potential of our allogeneic cell therapy product to provide patients and physicians with improved treatment outcomes.“
The Phase IIA trial in lumbar spinal fusion is designed to evaluate the safety and efficacy of the addition of ALLOB® to the standard of care procedure, in which an interbody cage with bioceramic granules is implanted to achieve fusion of the lumbar vertebrae. Endpoints of the study include radiological assessments: the evaluation of fusion and intervertebral mobility; and clinical assessments: the improvement in functional disability and reduction in pain; and safety assessments. Positive interim safety and efficacy results were reported in September 2017.
About Spinal Fusion
Due to ageing populations and sedentary lifestyles, an increasing amount of people are suffering from degenerative spine disorders. Spinal fusion is considered as the gold standard surgery for treating a broad spectrum of degenerative spine disorders 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, – placed into the intervertebral space – for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Over 500,000 lumbar spinal fusions are performed each year in Europe and the US and the market is growing at a rate of 5% per year. Although spinal fusion surgery is routine, non-union and failure to relieve pain are still frequent and up to 35% of spinal fusion patients are not completely satisfied with their surgery.
About Bone Therapeutics
Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.
Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.
Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis, and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.
Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.
SOURCE: Bone Therapeutics
Post Views: 21
Efficacy and safety results expected in mid-2019
Promising interim efficacy and safety data already reported
GOSSELIES, Belgium I February 19, 2018 I BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that it has completed the recruitment of its Phase IIA lumbar spinal fusion study with its allogeneic bone-cell therapy product, ALLOB®. Given this timing, efficacy and safety data for the full set of 32 patients are expected mid-2019, following a follow-up period of 12 months.
Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “We are pleased to announce recruitment of the last patient into our Phase IIA spinal fusion study with ALLOB®, on schedule. Our promising interim results showed bone formation in ALLOB®-treated patients, who also reported significant improvement in pain and day to day functional abilities. We look forward to reporting the full data set in mid-2019 as further positive results would continue to confirm the potential of our allogeneic cell therapy product to provide patients and physicians with improved treatment outcomes.“
The Phase IIA trial in lumbar spinal fusion is designed to evaluate the safety and efficacy of the addition of ALLOB® to the standard of care procedure, in which an interbody cage with bioceramic granules is implanted to achieve fusion of the lumbar vertebrae. Endpoints of the study include radiological assessments: the evaluation of fusion and intervertebral mobility; and clinical assessments: the improvement in functional disability and reduction in pain; and safety assessments. Positive interim safety and efficacy results were reported in September 2017.
About Spinal Fusion
Due to ageing populations and sedentary lifestyles, an increasing amount of people are suffering from degenerative spine disorders. Spinal fusion is considered as the gold standard surgery for treating a broad spectrum of degenerative spine disorders 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, – placed into the intervertebral space – for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Over 500,000 lumbar spinal fusions are performed each year in Europe and the US and the market is growing at a rate of 5% per year. Although spinal fusion surgery is routine, non-union and failure to relieve pain are still frequent and up to 35% of spinal fusion patients are not completely satisfied with their surgery.
About Bone Therapeutics
Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.
Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.
Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis, and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.
Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.
SOURCE: Bone Therapeutics
Post Views: 21
