Rexahn Pharmaceuticals Submits Archexin Phase II Protocol for Ovarian Cancer to FDA - News

Rexahn Pharmaceuticals Submits Archexin Phase II Protocol for Ovarian Cancer to FDA

May 08, 2012 08:03 AM Eastern Daylight Time 

ROCKVILLE, Md.--(EON: Enhanced Online News)--Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase II protocol for the clinical study of Archexin^® as a treatment of ovarian cancer to the U.S. Food and Drug Administration (FDA).

“Treatment options are limited for patients who are stricken with ovarian cancer, therefore we look forward to investigating Archexin as a potential combination treatment for this disease.”

The Phase II study will assess the safety and efficacy of Archexin when used in combination with both carboplatin and paclitaxel as a second-line therapy in subjects who are platinum-sensitive following their first relapse. The study will be conducted at multiple centers in the United States, and subjects will be randomized to receive either carboplatin/paclitaxel or carboplatin/paclitaxel/Archexin. Various measures of clinical benefit will be assessed

Second-line treatment of first relapse recurrent ovarian cancer - Australian and New Zealand Journal of Obstetrics and Gynaecology - abstract