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OSTEOGROW - A BMP6 containing bone graft substitute in clinical trials

A novel BMP6 based approach has been developed with superior healing results and reduced side effects in preclinical studies. BMP6 containing osteogenic medicinal product called Osteogrow aimed to induce and accelerate bone formation is currently being tested in clinical studies. It comprises of an autologous carrier made from the peripheral blood (ABC – autologous blood carrier) and of rhBMP6. Such formulation circumvents the use of animal-derived materials, significantly limits inflammatory processes and renders the carrier flexible and injectable ensuring the ease of use. Primary objectives of the 1. phase of clinical trials were to evaluate safety and pharmacokinetics (PK) of Osteogrow delivered locally to the closed distal radius fracture site. Patients were randomly assigned in 3 groups : 1. Control – standard of care, 2. Placebo – ABC, 3. Treatment – ABC+rhBMP6. For PK rhBMP6 was measured in plasma at timepoints of 0, 15, 30, 45, 60, 90, 120, 240, 360, 720 and 1440 minutes while for safety rhBMP6 raised antibodies were measured in serum at timepoints at 0, 13 and 26 weeks. Osteogrow device is formulated form 1 mL of autologous blood and 250 μg of rhBMP6, while placebo is formed from 1 mL of autologous blood. BMP6 concentration was measured in plasma by ELISA method, and BMP6 antibody concentration was measured in serum by indirect ELISA method. Plasma and serum samples from first ten human subjects participating in the clinical study did not show measurable amounts of rhBMP6 or BMP6 antibody at any time point. Evaluation of OSTEOGROW in the phase 1. clinical trials showed that there were no potential side effects in treatment of humans with distal radius fracture. The use of a small dose of rhBMP6 minimized the risk of side effects and antibody production as opposed to available therapy with large dose BMP2 or BMP7 with the similar application.

BMP6, bone regeneration, bone graft substitute, autologous carrier, clinical trials

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