Spinal Restoration’s Phase III study of Biostat System yields disappointing results

21 July 2013 (Last Updated July 21st, 2013 18:30)

Texas-based minimally invasive therapies developer Spinal Restoration has said that its Phase III Investigational New Drug (IND) study conducted to test the effectiveness of Biostat System did not show satisfactory results.

Texas-based minimally invasive therapies developer Spinal Restoration has said that its Phase III Investigational New Drug (IND) study conducted to test the effectiveness of Biostat System did not show satisfactory results.

Following the completion of 26 weeks, the percentage of successful patients who received Biostat Biologx Fibrin Sealant Injection with the Biostat System was not significant statistically than those who received regular saline injections, the company claimed.

For the study, which was conducted at 20 centres in the US, 220 patients suffering with single-level discogenic low back pain were randomly selected.

These patients were given Biostat Biologx Fibrin Sealant or saline in a 3:1 ratio with Biostat System.

During a separate safety arm of the study, a further 40 patients, who were selected non-randomly, were administered Biostat Biologx Fibrin Sealant injections at two lumbar levels.

About 96% of the patients completed 26-week visits, while 50% of the patients completed 78-week extended follow-up visits.

During the analysis, at 26 weeks, it was found that only 33.5% of patients who were administered the company's saline injection met the pre-specified composite definition of subject success as against 39.3% of patients in the saline control arm.

"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 study also found that improvements in low back pain were reported in 42.1% Biostate Biologx group and 50.0% of the control subjects.

In addition, 52.4% of Biostat Biologx subjects reported improvements in the Roland-Morris disability questionnaire as against 50% of control group.

These outcomes were similar to those reported in the safety arm of the study.

Spinal Restoration president and CEO Gary Sabins said that the outcomes of the Phase III study were 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," Sabins said.

"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.

"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."

Patient enrolment was completed in July last year, while the data acquired was rolled out in early 2013 in order to conduct the primary endpoint analysis.

The company is now identifying the appropriate next steps for the Biostat System.