Isolagen successful in dermal trial

Isolagen’s randomized, double-blind, placebo-controlled phase III trial, conducted at five sites in the US, consisted of two studies 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% to 7.6%.

Dr Marie Lindner, senior vice president of Medical and Business Affairs at Isolagen, stated: “We believe that the results from the trial demonstrate that the Isolagen Process can be used successfully to treat contour deformities. However, we think the wide variance in results precludes a BLA filing at this time.

“Therefore, in November 2005, Isolagen plans to initiate a 100-patient, clinical trial with a six-month endpoint the results of which could be combined with the successful results from Study B to support a BLA filing in 2006. In this new trial, only physicians trained in the proper Isolagen injection technique will participate as investigators in this trial.”