Rexahn Completes Patient Enrollment in Phase IIa Clinical Trial of ZoraxelTM to Treat Erectile Dysfunction

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Mon Jan 26, 2009 8:00am EST

ROCKVILLE, Md.--(Business Wire)--
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 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. 



KCSA Strategic Communications
Jeffrey Goldberger / Yemi Rose, 212-896-1249 / 212-896-1233
jgoldberger@kcsa.com / yrose@kcsa.com

Copyright Business Wire 2009

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