Rexahn Pharmaceuticals Submits Archexin Phase II Protocol for Ovarian Cancer to FDA

ROCKVILLE, Md.--(BUSINESS WIRE)-- Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase II protocol for the clinical study of Archexin^® as a treatment of ovarian cancer to the U.S. Food and Drug Administration (FDA).

The Phase II study will assess the safety and efficacy of Archexin when used in combination with both carboplatin and paclitaxel as a second-line therapy in subjects who are platinum-sensitive following their first relapse. The study will be conducted at multiple centers in the United States, and subjects will be randomized to receive either carboplatin/paclitaxel or carboplatin/paclitaxel/Archexin. Various measures of clinical benefit will be assessed.

Ovarian cancer is the fifth most common cancer among women, and it causes more deaths than any other type of female reproductive cancer.

“Treatment options are limited for patients who are stricken with ovarian cancer, therefore we look forward to investigating Archexin as a potential combination treatment for this disease.” said Rick Soni, President of Rexahn. “To date, Archexin has demonstrated promising safety profile, and it has been granted orphan drug designation in ovarian cancer and several other solid tumors by the FDA. We expect to report preliminary Phase IIa results from our pancreatic cancer trial with Archexin later this year.”

About Archexin^®

Archexin is a first-in-class, potent Akt protein kinase inhibitor with potential utility to inhibit cancer cell survival and proliferation, angiogenesis and drug resistance. Based upon Phase I clinical trial data, Archexin has an excellent human safety profile, with fatigue being the only side effect. Archexin has FDA Orphan drug designation for five different cancer types, including renal cell carcinoma, glioblastoma, pancreatic, stomach and ovarian cancers.

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to developing and 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®, Serdaxin®, and Zoraxel™ 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

To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about Rexahn's plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Rexahn's actual results to be materially different than those expressed in or implied by Rexahn's forward-looking statements. For Rexahn, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of Rexahn's licensees or sublicensees; the success of clinical testing; and Rexahn's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect Rexahn's actual results are described in Rexahn's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. Rexahn undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Rexahn Pharmaceuticals, Inc.
Investor Relations
Stern Investor Relations, Inc.
Stephanie Ascher, 212-362-1200
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or
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Constantine Theodoropulos, 617-816-4637
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Source: Rexahn Pharmaceuticals, Inc.

Released May 8, 2012