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Clinical Trials

Date: 2015-09-07

Type of information: Initiation of preclinical development

phase: 1-2a

Announcement:

Company: Bone Therapeutics (Belgium)

Product: ALLOB®

Action mechanism:

cell therapy. ALLOB® is an allogeneic, differentiated 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® has shown safety and efficacy in preclinical studies and does not require any immunosuppressive side therapy.

Disease: delayed union fractures

Therapeutic area: Bone diseases - Regenerative medicine

Country: Belgium, UK, Germany

Trial details:

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. (NCT02020590)

Latest news:

* On September 7, 2015, Bone Therapeutics, the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, announcee it has completed treatment without any safety concerns of the second cohort of patients in the ALLOB® Phase I/IIA trial for patients with delayed-union fractures. The Safety Monitoring Committee, composed of medical experts, met to review the initial safety data of the two cohorts and following analysis of clinical, laboratory and biological parameters, the committee unanimously agreed that the trial can proceed as planned and can continue to enrol patients. One patient of the second cohort has also been included in a sub-study to investigate the biodistribution of the ALLOB® cells through the body and to confirm their presence at the fracture site after administration. By radioactively labelling a fraction of the ALLOB® cells before injection, the cells can be traced up to 72 hours after administration using SPECT scans2. Results from this sub-study are an important support for future efficacy results, as the continued gathering of the cells at the fracture site is important for the therapy to have an optimal effect.

* On March 2, 2015, Bone Therapeutics announced that the Competent Authorities and Central Ethics Committee in the UK have granted Bone Therapeutics authorisation to extend its Phase I/IIA trial for its cell therapy product ALLOB® in the UK, while the first steps have been taken to receive approval for the trial in France.  The approval to extend the trial in the UK will allow the addition of two new sites, the King’s College Hospital in London and Norfolk and Norwich University Hospitals NHS Foundation Trust. A total of 14 centres across Belgium, Germany and the UK have now received authorization to enrol patients into the Phase I/IIA delayed-union trial. In France, a total of 4 centres is considered. Together, this will ensure coverage of all large European countries.

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. Patients receive a single percutaneous administration of ALLOB® directly into the fracture site, after which fracture healing is assessed and compared to baseline by clinical and radiological evaluation at two weeks, one, three and six months. Data gathered from the first cohort of four patients have already demonstrated excellent safety and efficacy.

* On December 16, 2014, Bone Therapeutics announced that its Safety Monitoring Committee (SMC) unanimously recommends the continuation of the Phase I/IIa trial with the allogeneic 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.

* On October 9, 2014, Bone Therapeutics announced that its phase I/IIa trial with the allogeneic osteoblastic cell therapy product ALLOB® for the treatment of delayed union fractures has been approved by the Paul-Ehrlich-Institute, the national authority in Germany. Four major German centres: Universitätsklinikum Köln, Universität Würzburg Orthopädische Klinik, Universitätsklinikum Schleswig Holstein in Lübeck and Klinikum rechts der Isar in München, are now approved to conduct the proof of concept phase I/IIa trial of ALLOB®. A total of nine centres across Belgium and Germany are now approved. This will only be the second clinical trial approval of an allogeneic regenerative therapy product authorized in Germany in an orthopaedic condition.

* On June 25, 2014, Bone Therapeutics announced that the first patient has been treated with its novel allogeneic osteoblastic (bone-forming) cell therapy product ALLOB® in its phase I/IIa study for the treatment of delayed union fractures. These fractures are defined by the absence of fracture healing after 3 months. 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® required about 20 minutes and took place at the day-clinic. ALLOB® is injected by the orthopaedic surgeon in a single dose percutaneously, directly into the fracture site. No side-effects have yet been reported.

* On October 1, 2013, Bone Therapeutics, a biopharmaceutical company focused on cell therapy products for the treatment of bone diseases, has announced that it has received clearance from the Competent Authorities in Belgium and the UK for a phase I/IIa trial with its allogeneic cell therapy product ALLOB® for the treatment of delayed union fractures. This first-in-human, proof-of-concept, phase I/IIa study is a 6 months open-label trial to evaluate the safety and efficacy of ALLOB® in the treatment of delayed union fractures of long bones. Thirty-two patients will be enrolled in 10 centers. They will receive a single percutaneous administration of ALLOB® directly into the fracture site. ALLOB®-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.
Bone Therapeutics has already secured both ‘Tissue Establishment’ and ‘GMP’ Accreditation for the in-house manufacturing of ALLOB®. This not only allows Bone Therapeutics to have enhanced control over ALLOB®’s production, but secures the manufacturing runway for scale up of production to support ALLOB®’s further development.

Is general: Yes