Posted by Michael Wonder on 01 Apr 2017
Aura Biosciences announces initiation of Phase 1b clinical trial and receipt of FDA fast track designation for AU-011 for the treatment of primary ocular melanoma
30 March 2017 - First patient dosed with light-activated AU-011 at Wills Eye Hospital in Philadelphia.
Aura Biosciences announced today that it has enrolled and dosed the first patient in its Phase 1b clinical trial of light-activated AU-011, an investigational, first-in-class targeted therapy in development for the treatment of ocular melanoma, a rare and life-threatening disease.
Aura additionally announced today that the U.S. FDA has granted AU-011 fast track designation for the treatment of primary ocular melanoma, also known as uveal or choroidal melanoma. This designation enables Aura to have more frequent interactions with the FDA throughout AU-011’s drug development process, as well as priority review of the new drug application.
