Rexahn Pharmaceuticals Receives New US Patent

Rexahn Pharmaceuticals, Inc. recently announced that the United States Patent and Trademark Office has issued US Patent No. 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, PhD, Chief Executive Officer of Rexahn, said “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 2a 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.

Rexahn Pharmaceuticals Inc. 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. Preclinical 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, visit www.rexahn.com.