Bone Biologics provides scientific update on NB1 bone graft device

Bone Biologics provides an update on its clinical development initiatives with its NB1 bone graft device. NB1 consists of the recombinant human protein NELL-1 combined with demineralized bone matrix . The 30-patient pilot study is expected to be conducted in Australia. Earlier this year, the Human Research Ethics Committee approved Monash Health as the first site. “We are encouraged by the ongoing progress in preparing to advance NB1 into human testing and look forward to the start of our pilot study before the end of the year,” said Jeffrey Frelick, president and chief executive officer of Bone Biologics. The company has completed the following preparatory activities: Assay Qualification and Validation All analytical assays required for the drug substance and the drug product have been successfully validated. Similar recombinant human NELL-1 or rhNELL-1, drug substance attributes were demonstrated between different rhNELL-1 lots and the cGMP drug substance lot. The in vitro cell-based attachment potency assay has been successfully qualified. Similar relative potency was demonstrated between different rhNELL-1 lots and the cGMP drug substance lot has passed the potency specification. In vivo potency testing demonstrated osteopromotion activity for the cGMP rhNELL-1 drug substance. The engineering and the cGMP drug substance lots have passed all required specifications. Medical Device Biocompatibility Testing The ISO 10993 GLP biocompatibility testing has been completed. NB1 showed no evidence of causing cell lysis or toxicity, no sensitization and was not mutagenic or pyrogenic. The clinical observations, body weights, necropsy observations, organ weights, organ/body weight ratios and organ/brain weight ratios were not adversely affected.