Rexahn Pharmaceuticals, Inc. (RNN) Submits Phase II Protocol To FDA For Clinical Study Of Archexin As Treatment For Ovarian Cancer

May 09, 2012 10:42 AM ETOCUP
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Yesterday, clinical stage pharmaceutical company Rexahn Pharmaceuticals, Inc. announced it has submitted a phase II protocol to the U.S. Food and Drug Administration for the clinical study of Archexin(R) as a treatment for ovarian cancer.

Archexin is a first-in-class Akt protein kinase inhibitor that has the potential utility to inhibit cancer cell survival and proliferation, angiogenesis, and drug resistance. Based on data from the phase I clinical trial, Archexin has an excellent human safety profile, with fatigue as its only side-effect. Archexin has received FDA Orphan drug designation for five difference cancer types, including renal cell carcinoma, glioblastoma and pancreatic, stomach, and ovarian cancers.

The phase II study of Archexin will assess its safety and efficacy when used in combination with carboplatin and paclitaxel as a second-line therapy in patients who are platinum-sensitive following their first relapse. The study will take place at multiple centers in the U.S., and subjects will be randomized to receive either carboplatin/paclitaxel or carboplatin/paclitaxel/Archexin. The study will assess various measures of clinical benefit.

Treatment options are currently limited for patients with ovarian cancer, which is the fifth most common cancer among women and causes more deaths than any other type of female reproductive cancer. For this reason, Rexahn Pharmaceuticals looks forward to investigating Archexin as a potential combination treatment for the disease. The company expects to report preliminary phase IIa results from its pancreatic cancer trial with Archexin later this year.

Rexahn Pharmaceuticals is a clinical stage pharmaceutical company focused on the development and commercialization of first-in-class and market-leading therapeutics for cancer, CNS disorders, sexual dysfunction, and other unmet medical needs. The company currently has three drug candidates in phase II clinical trials: Archexin(R), Serdaxin(R), and Zoraxel(R). Rexahn Pharmaceuticals additionally has a robust pipeline of preclinical compounds for treating multiple cancers and CNS disorders. The company operates key R&D programs of nano-medicines, 3D-GOLD, and TIMES drug discovery platforms.

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