Spinal Restoration Completes Back Pain Enrollment Study
The lack of definitive answers over the source of lower back pain continues to confound surgeons and patients and give payers fodder to limit payment coverage.
However, addressing and understanding discogenic pain may have taken a step forward when Austin-based Spinal Restoration, Inc. announced on July 11, the completion of enrollment in the Phase III Investigational New Drug (IND) study of the company's Biostat System.
According to the company's web site, research indicates that a specific diagnosis of back pain can only be made in 20% of cases based upon neurological evaluation and imaging studies. Discography studies show that approximately four million patients annually, have back pain attributable to disruptions of the internal structure within the intervertebral discs. This condition, referred to as discogenic pain, currently has no widely accepted therapy other than surgical spinal fusion.
The company believes that application of the system’s fibrin sealant to the disc may alleviate discogenic pain by sealing the painful disc disruptions, reducing inflammation, and enhancing tissue repair.
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 centers across the U.S.
The Principal Investigator Kevin Pauza, M.D., of Spine Specialists in Tyler, Texas, made quite a stir on May 6, 2012, when a national TV program (CBS Sunday Morning) focused attention on the Phase III clinical study.
The purpose of the investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving Biostat Biologx Fibrin Sealant through the Biostat Delivery Device and another group receiving a preservative-free normal saline control delivered with the same delivery device.
Potential Far-Reaching Impact
The study is, "one of the most ambitious clinical studies ever attempted by interventional spine physicians, " said Gary Sabins, president and CEO of Spinal Restoration. “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 company believes the 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 the company reached Special Protocol Assessment (SPA) concurrence with the U.S. 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 six-month primary endpoint.
Under an SPA, the FDA is supposed to grant clearance if certain pre-set, agreed upon criteria are met upon the final data analysis. This should be a good measure of the FDA's new emphasis and commitment to promoting innovation.
Additional information about the Biostat System study is available at www.clinicaltrials.gov (Study identifier: NCT01011816). Spinal Restoration expects the outcomes from this study, along with data from its previous preclinical and pilot clinical studies, to provide the basis for a Biologic License Application to the FDA in 2013.