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the move to bring fenretinide development back to San Diego after the Florida biotech hit the economic doldrums in 2009.
Lichter says fenretinide was originally under development as a potential anti-cancer drug in the 1980s by Johnson & Johnson. That effort was shelved after the compound showed no efficacy as a cancer drug, although those early studies showed what Lichter called “a very good safety record” for the compound that has been used in subsequent studies.
Fenretinide was identified as a possible drug for treating macular degeneration roughly a decade ago, because it interferes with a binding process that helps move retinol, a form of vitamin A, into the eye, according to Lichter. Researchers suspect that toxic byproducts associated with retinol contribute to macular degeneration.
The results of the Phase 2b clinical trials exceeded expectations by showing an unanticipated benefit, according to Lichter. Patients who were given the drug orally once a day showed a lower incidence in the progression of macular degeneration—by more than 50 percent—from an early stage condition known as “dry” AMD (for Age-related Macular Degeneration) to a more serious form known as “wet” AMD.
The trial, which enrolled 246 patients, also showed that fenretinide reduces the growth of lesions that can form on the retina in patients with the most advanced form of dry AMD. Fenretinide also was found to be safe and well tolerated, with no severe drug-related adverse events, and no significant effects on normal vision.