ROCKVILLE, Md., Aug. 30, 2017 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing innovative, targeted therapeutics for the treatment of cancer, today announced that the United States Patent and Trademark Office has issued U.S. Patent 9,744,167, “Nanoparticulate Formulations and Compositions of Piperazine Compounds”. The patent covers novel formulations of Supinoxin™ and is expected to provide additional patent protection until 2034.
Peter D. Suzdak, Ph.D., Chief Executive Officer of Rexahn, stated, “This new patent will extend the period of patent protection for Supinoxin™ and augment the value to Rexahn and to future potential partners. We are making good progress with the clinical development of Supinoxin™. We have completed a Phase I dose escalation study in cancer patients and we initiated a Phase IIa clinical study in patients with triple negative breast cancer earlier this year. We believe that the value created as we advance Supinoxin™ through the clinic will be further enhanced with the strengthening and extension of the patent portfolio.”
Supinoxin™ (RX-5902) is an orally administered, potential first-in-class, small molecule modulator of the β-catenin pathway – a key biological pathway that is activated in tumor cells leading to production of multiple cancer oncogenes and tumor proliferation and metastasis. Supinoxin™ modulates the pathway through inhibition of the interaction of phosphorylated p68 (a regulatory protein) with β-catenin.
Supinoxin™ has been shown to significantly inhibit tumor growth in a preclinical xenograft model of triple negative breast cancer. In addition, it was shown to have markedly synergistic effects when used in combination with a range of commonly used cytotoxics including paclitaxel, cisplatin and doxorubicin against triple negative breast cancer cell lines in in vitro studies.
Supinoxin™ has been evaluated in a Phase I dose-escalation study in patients with a diverse range of metastatic, treatment-refractory tumors including breast, ovarian, colorectal and neuroendocrine tumors. Supinoxin™ was safe and well tolerated at the doses tested with no dose limiting toxicities or treatment-related serious adverse events. The most frequently reported drug related adverse events were mild nausea, vomiting and fatigue. The study showed preliminary evidence of clinical activity with seven patients experiencing disease stabilization and three patients continuing treatment beyond one year.
In February 2017, Rexahn initiated a Phase IIa clinical proof-of-concept study to evaluate the safety and efficacy of Supinoxin™ monotherapy in patients with metastatic triple negative breast cancer who have failed multiple prior chemotherapeutic regimens.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals Inc. (NYSE MKT:RNN) is a clinical stage biopharmaceutical company dedicated to developing novel, targeted therapeutics for the treatment of cancer. The Company's mission is to improve the lives of cancer patients by developing next generation cancer therapies that are designed to maximize efficacy while minimizing the toxicity and side effects traditionally associated with cancer treatment. Rexahn's product candidates work by targeting and neutralizing specific proteins believed to be involved in the complex biological cascade that leads to cancer cell growth. Pre-clinical studies show that certain of Rexahn's product candidates may be effective against multiple types of cancer, drug resistant cancers, and difficult-to-treat cancers, and others may augment the effectiveness of current FDA-approved cancer treatments. The Company has a broad oncology pipeline that includes three anti-cancer compounds currently in clinical development: Supinoxin™, RX-3117, and Archexin®, and a novel nanopolymer-based drug delivery platform technology that may increase the bio-availability of FDA-approved chemotherapies. For more information about the Company and its oncology programs, please visit www.rexahn.com.
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 US PTO actions, patent protection, enrollments in clinical trials, the path of clinical trials and development activities, 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, understandings and beliefs regarding the role of certain biological mechanisms and processes in cancer; drug candidates being in early stages of development, including clinical development; the ability to initially develop drug candidates for orphan indications to reduce the time-to-market and take advantage of certain incentives provided by the U.S. Food and Drug Administration; the ability to transition from our initial focus on developing drug candidates for orphan indications to candidates for more highly prevalent indications; the expected timing of results from our clinical trials; the uncertainties associated with intellectual property protection. 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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