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Market: AMEX
Sector: Pharmaceuticals & Biotechnology
EPIC: RNN
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Rexahn Pharmaceuticals
www.rexahn.com

Rexahn’s goal is to be a world-class biopharmaceutical company developing and delivering novel cures for cancer and disorders of the central nervous system (CNS) to patients worldwide. Leveraging a powerful, multi-faceted discovery engine consisting of small signaling molecule discovery, computational modeling and nanotechnology-based drug targeting and delivery, we believe that we are well on our way to achieving our goal.

Full Rexahn Pharmaceuticals profile here
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Rexahn Pharma to Initiate Zoraxel Phase IIb trial for treating erectile dysfunction

13th May 2010, 10:52 am

Rexahn Pharmaceuticals Inc (AMEX: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and central nervous system (CNS) therapeutics, said it will initiate a Phase IIb clinical trial for Zoraxel in the treatment of erectile dysfunction (ED).

The Phase IIb study is designed to assess Zoraxel’s efficacy in approximately 225 male subjects, ages 18 to 65, with ED. The double blind, randomized, placebo-controlled, 12-week study will include the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) survey, and quality of life study endpoints.

The Phase IIb study is expected to begin in the second half of 2010 and the preliminary data is expected to be available in 2011. The study will be conducted at multiple sites in the US.

Rexahn’s decision to move forward with the Phase IIb trial is supported by data from a Phase IIa proof of concept study of 39 ED patients treated with Zoraxel.

The Phase IIa study was completed in May 2009 and demonstrated that Zoraxel consistently improved IIEF scores of treated subjects. Furthermore, the study found that treated subjects demonstrated a dose dependent treatment effect with improved erectile function and quality of life measures. Zoraxel was also found to be safe and well tolerated, with no serious adverse events reported.

Rexahn currently has three drug candidates in Phase II clinical trials, Archexin, Serdaxin, and Zoraxel - all potential best in class therapeutics - and a pipeline of preclinical compounds in development to treat multiple cancers and CNS disorders. Rexahn also operates key R&D programs of nano-medicines, 3D-GOLD, and TIMES drug discovery platforms.

Zoraxel is being developed as an orally administered tablet for on-demand use, and is one of three clinical stage compounds being developed by Rexahn. Zoraxel has a well established and excellent safety record in humans and studies demonstrate a lack of severe side effects associated with current standard of care phosphodiesterase (PDE-5) inhibitor ED drugs. Zoraxel is a centrally acting, dual enhancer of serotonin and dopamine in the brain, whereas PDE-5 inhibitors work in peripheral blood vessels.

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