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).
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.”
Archexin is a first-in-class, potent Akt protein kinase inhibitor with potential utility to inhibit cancer cell survival and proliferation, angiogenesis and drug resistance. Based upon Phase I clinical trial data, Archexin has an excellent human safety profile, with fatigue being the only side effect. Archexin has FDA Orphan drug designation for five different cancer types, including renal cell carcinoma, glioblastoma, pancreatic, stomach and ovarian cancers.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to developing and commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. Rexahn currently has three drug candidates in Phase II clinical trials, Archexin®, Serdaxin®, and Zoraxel™ and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders. Rexahn also operates key R&D programs of nano-medicines, 3D-GOLD, and TIMES drug discovery platforms. For more information, please visit
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