Rexahn Pharmaceuticals Submits Zoraxel Phase IIb Protocol to FDA
Company Forms Urology Scientific Advisory Board
ROCKVILLE, Md.--(BUSINESS WIRE)-- Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase IIb protocol to the FDA for ZoraxelTM for the treatment of erectile dysfunction (ED).
"The progression of Zoraxel's clinical program is very encouraging," said Rexahn Chief Executive Officer, Dr. Chang Ahn. "We believe that the future of ED treatment lies in compounds that act on the central nervous system and effectively modify the condition, rather than targeting end organ erectile function. Zoraxel has the potential to be the first drug capable of this action and to establish a new standard of care for erectile dysfunction."
The Phase IIb study will continue 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 Sexual Encounter Profile (SEP) survey, International Index of Erectile Function (IIEF) and quality of life study endpoints and will be conducted at multiple sites in the U.S. Data from the Phase IIa study completed in May 2009 reported that subjects treated with Zoraxel demonstrated improved erectile function and significant improvement in the quality of life measures. The study also found Zoraxel to be safe and well tolerated, with no serious adverse events reported.
Rexahn also announced the formation of a Urology Scientific Advisory Board (SAB). The SAB is composed of key opinion leaders in the field of urology who will advise Rexahn on the design and development of Zoraxel clinical trials. The members of the SAB include Arthur L. Burnett, M.D., M.B.A., F.A.C.S., Patrick C. Walsh Professor of Urology at The Johns Hopkins University; and Culley C. Carson III, M.D., F.A.C.S., Rhodes Distinguished Professor and Chief of Urology at University of North Carolina.
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. Rexahn currently has three drug candidates in Phase II clinical trials, Archexin(TM), Serdaxin(R), and Zoraxel(TM) - all potential best in class therapeutics - and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders. Rexahn also operates key R&D programs of nano-medicines, 3D-GOLD, and TIMES drug discovery platforms. 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, 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.
Source: Rexahn Pharmaceuticals, Inc.
Released March 3, 2010