Spinal Restoration, Inc., a company restores patients’ lives by delivering new therapies that address unmet needs in spine health management, completes enrollment in phase III Investigational New Drug (IND) study of the Biostat System. The phase III clinical trial is a 260-subject, randomized, blinded, placebo controlled study designed to assess the ability of the Biostat System to reduce pain and improve function in patients with chronic discogenic low back pain. The study is being conducted at 20 centres across the US.
The Biostat System is an investigational new drug and is limited by federal law to investigational use only. The Biostat System consists of Biostat Biologx Fibrin Sealant, a human derived, resorbable biologic tissue sealant, and the Biostat Delivery Device, a proprietary application system designed to safely and effectively deliver the biologic to the intervertebral disc. Application of Biostat Biologx Fibrin Sealant to the disc may alleviate discogenic pain by sealing the painful disc disruptions, reducing inflammation, and enhancing tissue repair.
Gary Sabins, president and CEO of Spinal Restoration, expressed high praise for the commitment and tireless efforts of the clinical investigator teams that are participating in the study. “The phase III study of the Biostat System is one of the most ambitious clinical studies ever attempted by interventional spine physicians. Spinal Restoration is extremely honoured to be working with this team of investigators who are dedicated to developing the rigorous scientific evidence necessary to clearly demonstrate the safety and efficacy of the Biostat System. ” Sabins concluded by saying, “If successful, the phase III study of the Biostat System could have an extensive, far-reaching impact on the diagnosis and treatment of millions of patients who suffer from the debilitating effects of chronic discogenic low back pain.”
The Biostat System is the first intradiscal biologic therapy for discogenic pain to complete enrollment of a phase III IND study. Enrollment of the study was initiated in 2010 after Spinal Restoration reached Special Protocol Assessment concurrence with the US Food and Drug Administration for the study design, endpoints, and planned statistical analysis. Study success will be determined by comparing the success rates of the investigational and control groups at the 6-month primary endpoint.