Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage biopharmaceutical company focused on developing first in class therapies for the treatment of cancer, today provided an update on its strategic business goals for 2013.
“I am pleased to report that Rexahn is positioned to achieve significant strategic milestones in 2013. The infusion of $9 million from our recently completed public offering and research funding from Teva Pharmaceuticals for RX-3117 will enable the company to accelerate the clinical development of Archexin, RX-3117, and RX-5902, while advancing three pre-clinical compounds closer to clinical development,” said Peter D. Suzdak, Ph.D., CEO of Rexahn. “Our anticipated clinical and pre-clinical development progress will both increase shareholder value and support our strategic partnering efforts,” added Dr. Suzdak.
Rexahn Goals for 2013:
- Identify and form strategic partnerships. Rexahn continues to explore potential strategic partnerships to accelerate the development of its oncology pipeline. Rexahn’s pipeline of innovative oncology compounds features six potential best-in-class compounds – three clinical stage compounds (Archexin, RX-3117 (already partnered with Teva Pharmaceuticals), and RX-5902) and three pre-clinical compounds (RX-21101, RX-0047-N, and RX-0201-N). Each of these compounds offers an opportunity for a partner to bolster its oncology portfolio with differentiated assets possessing high potential clinical value.
- Continue RX-3117’s clinical development with Teva Pharmaceuticals. RX-3117 is a proprietary small molecule compound that inhibits DNA methyltransferase and DNA synthesis and is being co-developed with Teva Pharmaceuticals for the treatment of cancer. In August 2012, Rexahn and Teva concluded a first-in-human clinical study of RX-3117. In the clinical study RX-3117 met its primary objective of determining the drug’s oral bioavailability in humans. The study supports RX-3117’s 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. As a result of this clinical study, Teva increased its ownership in Rexahn to 6.3%. According to the Research and Exclusive License Option Agreement and the Securities Purchase Agreement between Rexahn and Teva, the total money received from Teva to date is $9.1 million. Rexahn expects to receive additional milestone payments from Teva in the second half of 2013 with the submission of an IND and patient enrollment in a phase I clinical trial.
- Initiate a Phase I clinical study with RX-5902. In 2013 Rexahn expects to initiate a Phase I first-in-human clinical trial of RX-5902, an orally available, first-in-class inhibitor of p68 RNA helicase for the treatment of various solid tumors, such as melanoma and cancers of the ovary, kidney and pancreas. Preclinical studies have demonstrated the inhibition of tumor growth and enhanced survival in in vivo animal xenograft models, synergistic action when combined with known anticancer agents, and potent anti-growth activity in drug-resistant cancer cells.
- Initiate a Phase II clinical trial with Archexin. Archexin is a proprietary first-in-class inhibitor of Akt protein kinase (Akt) which is localized in cancer cells. Following the positive top-line phase IIa clinical trial results for Archexin in pancreatic cancer reported in August 2012, Rexahn plans to move forward with its Phase II clinical program in 2013. Rexahn completed an open label study of Archexin in 2012 to determine the safety, tolerability and efficacy of the compound in combination with gemcitabine. The 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.
About Rexahn Pharmaceuticals, Inc.Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to developing and commercializing first in class therapeutics for the treatment of cancer and other unmet medical needs. Rexahn currently has three clinical stage oncology candidates, Archexin ®, RX-3117, and RX-5902 and a robust pipeline of preclinical compounds to treat multiple types of cancer. Rexahn has also developed proprietary drug discovery platform technologies in the areas of nano-medicines, 3D-GOLD, and TIMES. 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.
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