Rexahn Reports Positive Preliminary Phase IIa Findings in Zoraxel Clinical Trial to Treat Erectile Dysfunction
Rockville, Md., February 23, 2009 - Rexahn Pharmaceuticals, Inc. (NYSE Alternext US: RNN), today announced preliminary Phase IIa clinical study results for its sexual dysfunction drug candidate, Zoraxel™. The double blind, placebo-controlled, dose ranging Phase IIa study found that human subjects treated with Zoraxel demonstrated improved erectile function as measured by changes over the International Index of Erectile Function (IIEF) baseline score within the 8-week treatment period.
The study, which was designed to assess Zoraxel’s safety and preliminary efficacy in male subjects ages 18 to 65 with Erectile Dysfunction (ED), demonstrated a dose dependent treatment effect achieved by Zoraxel as assessed by the IIEF survey. Zoraxel was found to be safe and well tolerated, with no serious adverse events reported. Furthermore, subjects treated with Zoraxel demonstrated improved erectile function in at least four IIEF survey domains, including erectile function, penetration, and maintenance ability. Planning is underway for the Phase IIb trial.
Rexahn Chief Executive Officer, Chang Ahn, PhD, commented, “These clinical study results are very encouraging, and further point to Zoraxel developing into a new class of sexual dysfunction drugs that establish a new standard of care in the treatment of erectile dysfunction.
About ZoraxelTM 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 drug pipeline. ZoraxelTM 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<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.
Paul Kidwell 617.296.3854: Office 617.680.1088: Mobile
Posted: May 2009