PRELIMINARY RESULTS ANNOUNCED IN DERMAL TRIAL
Isolagen announced that preliminary results from its Phase III clinical trial, which consisted of two simultaneous dermal studies, met three of the four primary end points and achieved statistical significance when the results of the two studies were combined.
Isolagen's randomized, double-blind, placebo controlled Phase III trial, conducted at five sites in the U.S., consisted of two studies (Study A and Study B) evaluating the safety and efficacy of the Isolagen Process for the treatment of contour deformities. Each study enrolled approximately 100 patients randomized evenly between treatment and placebo-controlled groups. The trial's primary efficacy end points were based on blinded physician and patient visual assessment using a six-point standardized photoguide scale with a two-point change required to meet the endpoint and blinded patient assessment using a 100 point visual analog scale.
Study B of the trial proved to be statistically significant with both patient and physician assessment achieving positive results. Study A results were mixed with a positive assessment from the patients only. Significantly, a wide variance in results was reported from site to site across both studies with response rates ranging from 73.3 percent to 7.6 percent. Comparison of the statistics from site to site suggests that results are dependent on injection technique. No major safety issues or serious adverse events were reported in either study.
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