Rexahn Completes Patient Enrollment In Phase IIa Clinical Trial Of ZoraxelTM To Treat Erectile Dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Clinical Trials / Drug Trials
Article Date: 28 Jan 2009 - 0:00 PDT

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Rexahn Pharmaceuticals, Inc. (NYSE Alternext US: RNN), a leader in development of innovative therapeutics for life-threatening and life-debilitating diseases, announced the completion of enrollment in its Phase IIa clinical trial evaluating ZoraxelTM for treatment of Erectile Dysfunction (ED). The Company expects to have preliminary study results in March 2009.

Zoraxel is being developed as an orally administered tablet for on-demand use, and is one of three compounds being developed by Rexahn as a part of the Company's clinical stage drug pipeline. In addition to lacking the common side effects associated with many popular ED treatments, Zoraxel has also been shown to significantly improve sexual arousal, erection, and release in disease model studies.

Dr. Chang H. Ahn, Chairman and CEO of Rexahn commented, "It has been our stated goal to move our three highly-marketable compounds successfully through the clinical trial process, and the completion of patient enrollment in the Zoraxel trial represents another steady step in the right direction for Rexahn. This milestone is especially meaningful to us, as we have long believed that our ED compound is a safer and more effective alternative to currently marketed drugs for ED. We look forward to examining and sharing the preliminary data with our shareholders and stakeholders in the near future."

The Zoraxel Phase IIa trial is a double blind, placebo-controlled, dose ranging study conducted at three U.S. study sites in up to 40 male subjects ages 18 to 65 with ED for six months. Main study endpoints for the 8-week treatment period were the Sexual Encounter Profile (SEP) and the International Index of Erectile Function (IIEF), both of which are validated surveys for assessing erectile function. Planning is underway for initiation of Phase IIb clinical studies.

About ZoraxelTM

ZoraxelTM is being developed as an orally administered, on-demand tablet. It has a well established and excellent safety record in humans and appears to lack severe side effects associated with standard of care phosphodiesterase (PDE-5) inhibitor ED drugs, such as priapism, severe hypotension, myocardial infarction, sudden death, increased intraocular pressure and sudden hearing loss. ZoraxelTM is a centrally acting, dual enhancer of neurotransmitters in the brain, whereas PDE-5 inhibitors only target end organ erectile function and work in peripheral blood vessels. In preclinical animal models, ZoraxelTM has significantly improved all three functions of sexual activity, i.e. sexual arousal, erection, and release, and may be a more effective ED treatment for patients who are responsive or unresponsive to PDE-5 inhibitors.

About Erectile Dysfunction (ED)

ED is defined as the consistent inability to attain and maintain an erection sufficient for satisfactory sexual intercourse. ED affects up to 30 million estimated men in the United States, with 52% of men between the ages of 40 and 70 reporting difficulty with erectile function. By the year 2025, it is estimated that 322 million men worldwide will suffer from some degree of sexual dysfunction.

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. For more information please visit http://www.rexahn.com

Safe Harbor

This press release contains forward-looking statements. Rexahn's actual results may differ materially from anticipated results, and expectations expressed in these forward-looking statements, as a result of certain risks and uncertainties, including Rexahn's lack of profitability, its auditor's going concern qualification and the need for additional capital to operate its business to develop its product candidates; the risk that Rexahn's development efforts relating to its product candidates may not be successful; the possibility of being unable to obtain regulatory approval of Rexahn's product candidates; the risk that the results of clinical trials may not be completed on time or support Rexahn's claims; demand for and market acceptance of Rexahn's drug candidates; Rexahn's reliance on third party researchers and manufacturers to develop its product candidates; Rexahn's ability to develop and obtain protection of its intellectual property; and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission. Rexahn assumes no obligation to update these forward-looking statements.

Rexahn Pharmaceuticals, Inc.