Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in oncology and CNS, today provided an update on its strategic business goals for 2012.
“I am pleased to report that Rexahn is executing to plan in 2012. Our primary objective for this year is to significantly advance and build the value of our oncology program,” said Dr. Chang Ahn, Chief Executive Officer, Rexahn. “Led by our recent positive Phase IIa clinical study results of Archexin in pancreatic cancer, I am pleased to report that we are accomplishing this goal. We are moving into the second half of this year with positive momentum.”
Rexahn Strategic Goals Update
- Reported positive top-line phase IIa clinical study results for Archexin. Archexin is being developed as a potential first-in-class inhibitor of the Akt protein kinase (Akt) in cancer cells. Rexahn conducted an open label study to determine the safety and efficacy of Archexin in combination with gemcitabine. This study demonstrated that this combination treatment provided a median survival of 9.1 months compared to the historical survival data of 5.65 months for standard single agent gemcitabine therapy. Rexahn is evaluating options for advancing Archexin, including finding a co-development partner (under Archexin’s orphan drug designation).
- Completed phase I human study of RX-3117. In August 2012 Rexahn concluded its first-in-human clinical study of RX-3117 with its co-development partner, Teva Pharmaceutical Industries. In the study RX-3117 positively met its primary objective of determining the drug’s oral bioavailability in humans. Furthermore, the study supports RX-3117 position as a potential future alternative to market leading anti-metabolite therapies in the treatment of solid tumors in the colon, lung, bladder and pancreas.
- Submitted investigational new drug (IND) application for First-in-Class p68 Helicase Inhibitor RX-5902. In July 2012 Rexahn submitted an IND for RX-5902, an exciting first-in-class p68 RNA helicase inhibitor that has considerable commercial potential. Pre-clinical studies have shown that RX-5902 exhibits very potent anti-tumor activity in various cancers including melanoma, renal, ovarian and pancreatic. Additional studies suggest that RX-5902 is effective in drug-resistant cancer cells and is synergistic when combined with current cancer drugs. Rexahn expects to begin patient enrollment in a Phase I clinical trial for RX-5902 in Q1, 2013.
- Active pursuit of new partnerships. Rexahn is in continuing dialogue with a range of potential partners, including out-licensing or co-development of the company’s promising oncology assets.
- Continuing evaluation of options for building additional value in CNS program (Serdaxin and Zoraxel). Rexahn is exploring options for further development of Serdaxin and Zoraxel, including out-licensing or divesture of the compounds, entering a co-development partnership, and continuation of clinical trials in Major Depressive Disorder for Serdaxin and Erectile Dysfunction for Zoraxel.
- Continue new CEO search. Rexahn continues its search for a Chief Executive Officer (CEO) to succeed Dr. Chang Ahn. The company expects to name a new CEO in 2012.
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.