Safety Monitoring Committee unanimously recommends the trial proceeds as planned
GOSSELIES, Belgium I December 16, 2014 I BONE THERAPEUTICS, the regenerative therapy company addressing unmet medical needs in the field of bone fracture repair and fracture prevention, announces today that its Safety Monitoring Committee (SMC) unanimously recommends the continuation of the Phase I/IIa trial with the allogeneic[1] osteoblastic cell therapy product ALLOB® following the treatment of four patients. The study will now proceed as planned and continue with the enrolment of patients.
After treatment of the first cohort of patients the SMC, consisting of one pharmacist and three medical doctors, including a pharmacovigilance expert, met to review the initial data two weeks post implantation to evaluate the study’s overall safety before treatment of the next cohort. A large collection of safety data was collected and analysed providing safety insight at clinical, laboratory and biological levels. Side effects, including Adverse Events Special Consideration (AESC) — especially in relation to the product and procedure — as well as measured clinically observable toxicity, were analysed. Specific laboratory parameters were also analysed including inflammation and immune parameters.
The ongoing Phase I/IIa study is a six month open-label trial to evaluate the safety and efficacy of ALLOB® in the treatment of delayed-union fractures of long bones. The study aims to recruit 32 patients in 17 centres in Belgium, the UK and Germany. All patients receive a single percutaneous administration of ALLOB® directly into the fracture site. An interim analysis evaluating safety and efficacy will be performed when the trial reaches 16 patients, which will allow the study to be prematurely terminated at that point. ALLOB®-treated patients will be assessed in comparison to baseline at two weeks, one, three and six months using clinical (e.g. pain, weight-bearing) and radiological evaluation.
Enrico Bastianelli, CEO of Bone Therapeutics commented: “We are pleased with the recommendation of the SMC and believe our unique “off-the-shelf” regenerative therapy product, ALLOB®, with its minimally invasive administration and low side effect profile truly has the potential to become the standard of care for patients with delayed-union fractures. We look forward to report the first efficacy results of this trial as it progresses”.
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. Traditional options for the treatment of an impaired fracture (i.e., bone graft) typically involve highly invasive surgery, which can be painful and require months of rehabilitation with the risk of serious complications (such as deep bone infection). Due to the risks of the current treatment, orthopaedic surgeons often take a “wait and see” approach to the treatment of delayed-union fractures, sometimes for several months, which delays the patient’s return to a normal life and leads to a significant financial burden to society. ALLOB® has the potential to become a first-line and early treatment for delayed-union fractures, thanks to its minimally invasive administration which avoids the need for major surgery.
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 Bone Therapeutics
Bone Therapeutics is a leading biotechnology company specializing in the development of innovative regenerative therapies for the repair and prevention of bone fractures. 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 products containing regenerative osteoblastic/bone-forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.
PREOB®, Bone Therapeutics’ autologous cell product, is currently in pivotal Phase III clinical studies for two indications: osteonecrosis and non-union fractures, and in Phase II for severe osteoporosis. ALLOB®, its allogeneic 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.
SOURCE: Bone Therapeutics
Post Views: 135
Safety Monitoring Committee unanimously recommends the trial proceeds as planned
GOSSELIES, Belgium I December 16, 2014 I BONE THERAPEUTICS, the regenerative therapy company addressing unmet medical needs in the field of bone fracture repair and fracture prevention, announces today that its Safety Monitoring Committee (SMC) unanimously recommends the continuation of the Phase I/IIa trial with the allogeneic[1] osteoblastic cell therapy product ALLOB® following the treatment of four patients. The study will now proceed as planned and continue with the enrolment of patients.
After treatment of the first cohort of patients the SMC, consisting of one pharmacist and three medical doctors, including a pharmacovigilance expert, met to review the initial data two weeks post implantation to evaluate the study’s overall safety before treatment of the next cohort. A large collection of safety data was collected and analysed providing safety insight at clinical, laboratory and biological levels. Side effects, including Adverse Events Special Consideration (AESC) — especially in relation to the product and procedure — as well as measured clinically observable toxicity, were analysed. Specific laboratory parameters were also analysed including inflammation and immune parameters.
The ongoing Phase I/IIa study is a six month open-label trial to evaluate the safety and efficacy of ALLOB® in the treatment of delayed-union fractures of long bones. The study aims to recruit 32 patients in 17 centres in Belgium, the UK and Germany. All patients receive a single percutaneous administration of ALLOB® directly into the fracture site. An interim analysis evaluating safety and efficacy will be performed when the trial reaches 16 patients, which will allow the study to be prematurely terminated at that point. ALLOB®-treated patients will be assessed in comparison to baseline at two weeks, one, three and six months using clinical (e.g. pain, weight-bearing) and radiological evaluation.
Enrico Bastianelli, CEO of Bone Therapeutics commented: “We are pleased with the recommendation of the SMC and believe our unique “off-the-shelf” regenerative therapy product, ALLOB®, with its minimally invasive administration and low side effect profile truly has the potential to become the standard of care for patients with delayed-union fractures. We look forward to report the first efficacy results of this trial as it progresses”.
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. Traditional options for the treatment of an impaired fracture (i.e., bone graft) typically involve highly invasive surgery, which can be painful and require months of rehabilitation with the risk of serious complications (such as deep bone infection). Due to the risks of the current treatment, orthopaedic surgeons often take a “wait and see” approach to the treatment of delayed-union fractures, sometimes for several months, which delays the patient’s return to a normal life and leads to a significant financial burden to society. ALLOB® has the potential to become a first-line and early treatment for delayed-union fractures, thanks to its minimally invasive administration which avoids the need for major surgery.
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 Bone Therapeutics
Bone Therapeutics is a leading biotechnology company specializing in the development of innovative regenerative therapies for the repair and prevention of bone fractures. 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 products containing regenerative osteoblastic/bone-forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.
PREOB®, Bone Therapeutics’ autologous cell product, is currently in pivotal Phase III clinical studies for two indications: osteonecrosis and non-union fractures, and in Phase II for severe osteoporosis. ALLOB®, its allogeneic 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.
SOURCE: Bone Therapeutics
Post Views: 135
