Spinal Restoration, Inc. announced today that the success criteria for primary analysis of the Phase III Investigational New Drug (IND) study of the Biostat® System were not met. The proportions of successful patients that received BIOSTAT BIOLOGX® Fibrin Sealant or saline injection were not statistically significantly different when analyzed at the 26-week primary endpoint.
The Phase III Investigational New Drug (IND) study was conducted at 20 centers in the US and randomized 220 subjects with single-level discogenic low back pain in a 3:1 ratio to injection of BIOSTAT BIOLOGX Fibrin Sealant or saline using the Biostat System. An additional 40 nonrandomized subjects received BIOSTAT BIOLOGX Fibrin Sealant injections at two lumbar levels in a separate safety arm of the study. Study enrollment was completed in July of 2012 and the study data was unblinded in early 2013 to conduct the primary endpoint analysis. Ninety-six percent of subjects completed the 26-week visit and 50% of subjects had completed the final 78-week extended follow-up visit at the time of the analysis.
At 26 weeks, 33.5% of subjects who received BIOSTAT BIOLOGX Fibrin Sealant met the prespecified composite definition of subject success compared to 39.3% of subjects in the saline control arm. Clinically meaningful improvements in low back pain were achieved in 42.1% and 50.0% of BIOSTAT BIOLOGX and control subjects, respectively. Clinically meaningful improvements in the Roland-Morris Disability Questionnaire were achieved in 52.4% of BIOSTAT BIOLOGX subjects and 50.0% of control subjects. The outcomes reported in the subjects treated at two lumbar levels were very similar to the results of the one level subjects.
Gary Sabins, President and CEO, commented, "The outcomes of the Phase III study are obviously very disappointing. We were very encouraged by the results obtained in our preclinical studies and pilot clinical trial and expected the Phase III study to provide clear evidence of efficacy for the Biostat System. Many subjects achieved significant, long-lasting improvements in their condition. Unfortunately, the benefits provided by injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat System could not be distinguished from the benefits provided by injection of saline."
Mr. Sabins concluded by saying, "While the study outcome is unfortunate for our investors, clinical investigators, employees and many potential patients, the study data provide valuable insights into the nature of discogenic back pain and patient response to treatment. The results emphasize the critical importance of rigorously conducted, multicenter, randomized, controlled studies to demonstrate true efficacy of proposed therapies for discogenic low back pain."
Spinal Restoration is currently determining the appropriate next steps for the Biostat System and the company.
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