Sirion Therapeutics Announces Positive Results From Interim Analysis Of Phase II Trial And Receives FDA Fast Track Designation For Fenretinide

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 16 Apr 2009 - 2:00 PDT

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Sirion Therapeutics, Inc. announced positive results from a planned interim analysis of its Phase II trial evaluating fenretinide for the treatment of geographic atrophy (GA) associated with age-related macular degeneration. This interim analysis was triggered when all patients had reached the 12 month visit.

The analysis compared the growth rate of GA lesions, as measured by retinal photography, in patients treated with daily doses of placebo or 100mg or 300mg of oral fenretinide. These data showed slower growth of the GA lesions for the 300mg 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 300mg 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 100mg 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. Sirion will meet with its scientific advisors and the FDA to design an appropriate Phase III program for fenretinide.

These data from this interim analysis will be presented at the Association for Research in Vision and Ophthalmology (ARVO) meeting in May 2009.

Sirion also announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for fenretinide for the treatment of geographic atrophy associated with age-related macular degeneration.

"Our receipt of Fast Track designation has the potential to accelerate the development of fenretinide for the treatment of geographic atrophy, which is a condition without a currently approved treatment," said Barry Butler, CEO of Sirion Therapeutics. "The Fast Track designation combined with our positive interim analysis results gives Sirion a great deal of optimism that we will be able to bring a much needed treatment option to patients with geographic atrophy."

About Fast Track Designation

The Fast Track programs of the FDA are designed to facilitate the development of drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address an unmet medical need for such a condition. Fast Track designation provides the option to submit a New Drug Application on a rolling basis, and thus enable the FDA to begin reviewing sections of the application before receiving the complete application. New Drug Applications for products with a Fast Track designation also generally receive a priority review designation, meaning the application will be reviewed in six months rather than the 10-month standard review time.

About Fenretinide

Fenretinide is an oral vitamin A binding protein antagonist being studied in patients with geographic atrophy (GA), the most advanced form of dry age-related macular degeneration (AMD). Fenretinide is believed to halt the accumulation of retinol (vitamin A) toxins through affinity for retinol-binding protein. It is also believed to slow the formation and accumulation of toxic byproducts thought to be responsible for vision loss in conditions such as GA.

About Geographic Atrophy

Geographic atrophy (GA) is characterized by confluent areas of cell death in photoreceptors and retinal pigment epithelium (RPE). GA is bilateral in more than half of afflicted patients and largely the cause of legal blindness from age-related macular degeneration. The cause of GA is attributed to age as well as other risk factors including family history and untreated hypertension.

About Sirion Therapeutics, Inc.

Sirion Therapeutics is a privately held biopharmaceutical company pursuing the discovery, development, and commercialization of products addressing unmet medical needs in the protection and preservation of eyesight. Sirion's diverse product portfolio includes products that address ocular diseases and conditions including uveitis, herpetic keratitis, dry eye, and geographic atrophy associated with dry AMD.

Source: Sirion Therapeutics, Inc

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