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).
“To date, Archexin has demonstrated promising safety profile, and it has been granted orphan drug designation in ovarian cancer and several other solid tumors by the FDA. We expect to report preliminary Phase IIa results from our pancreatic cancer trial with Archexin later this year.”
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.
Ovarian cancer is the fifth most common cancer among women, and it causes more deaths than any other type of female reproductive cancer.
"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." said Rick Soni, President of Rexahn. "To date, Archexin has demonstrated promising safety profile, and it has been granted orphan drug designation in ovarian cancer and several other solid tumors by the FDA. We expect to report preliminary Phase IIa results from our pancreatic cancer trial with Archexin later this year."
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