The company has received written confirmation from the U.S. Food and Drug Administration (FDA) regarding agreement on the design of its Phase 3 registration trials designed to evaluate light-activated AU-011 for the treatment of patients with choroidal melanoma. This written confirmation is the result of successful outcome of an “End of Phase 2” meeting with the FDA.
The data presented at the meeting show that multiple administrations of light-activated AU-011 are well-tolerated with no related serious adverse events, severe adverse events or dose-limiting toxicities observed.
Molecular Cancer Therapeutics
Kines R, Varsavsky I, Choudhary S, Bhattacharya D, Spring S, McLaughlin R, Kang S, Grossniklaus H, Vavvas D, Monks S, MacDougall J, de los Pinos E, Schiller J
Kaliki S and Shields C L