Zoraxel for treatment of ED: Rexahn Pharmaceuticals submits Phase IIb protocol to FDA

Rexahn Pharmaceuticals, Inc.Mar 4 2010

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 Zoraxel^TM for the treatment of erectile dysfunction (ED).

“The progression of Zoraxel’s clinical program is very encouraging”

“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.