Fenretinide Phase II trials results imminent

Interim analysis of Phase II trials for fenretinide and its use in the treatment of geographic atrophy (GA) are looking positive, according to Sirion Therapeutics, Inc. The results are due to be announced at the Association for Research in Vision and Ophthalmology (ARVO) meeting in May 2009.

Sirion believes that the drug halts the accumulation of retinol (vitamin A) toxins and other toxins thought to be involved in vision loss with AMD.

The growth rate of GA lesions, as measured by retinal photography was compared in patients treated with daily doses of placebo or 100 mg or 300 mg of oral fenretinide. These data showed slower growth of the GA lesions for the 300 mg dose for all lesion sizes at entry. This trend was evident as early as 6 months and increased over time. Among the sub-population of 78 patients who reached the 18 month study visit, the median growth rate of the lesions in the 300 mg group was 22.7% versus 41.6% in the placebo group, representing a 45% reduction in median lesion growth rate at month 18. The current study is powered to detect a 50% reduction in lesion growth rate at 24 months.Slower lesion growth was also observed in the 100 mg group among subjects who had lesions smaller than the median baseline at entry (approximately 3 disk areas). These data suggest that early intervention may improve outcomes.

Based on the results of this interim analysis, Sirion plans to continue the current study to its conclusion. It plans to meet with its scientific advisors and the FDA to design an appropriate Phase III programme for fenretinide.