Rexahn Pharma Offers Added Data for Supinoxin for Treatment of Triple Negative Breast Cancer

Rexahn Pharmaceuticals, Inc. (NYSE MKT:

), a clinical stage biopharmaceutical company developing next generation therapeutics for the treatment of cancer, announced today that additional data supporting the Company's novel, investigational anti-cancer therapeutic, Supinoxin™ (RX-5902), for the treatment of triple negative breast cancer, were presented at the 14th Annual Targeted Anticancer Therapeutics Congress (TAT 2016), held in Washington, DC March 21- 23, 2016. In an oral presentation entitled "Novel Targeted Phosphorylated p68 Inhibitor, RX-5902 (Supinoxin), Shows Activity in Triple-Negative Breast Cancer," Rexahn's collaborators at the University of Colorado, School of Medicine, delivered an overview of recent findings from the Supinoxin program further elucidating its novel cancer-cell specific mechanism of action and showing potent activity in various preclinical models of triple negative breast cancer (TNBC). "The nonclinical data for Supinoxin – along with human pharmacokinetic data from the ongoing Phase I study, provides valuable evidence from which to best inform our selection of a recommended Phase II dose for further evaluation of Supinoxin," said Dr. Ely Benaim, Chief Medical Officer for Rexahn. "Collectively, these data and the unique mechanism of action of Supinoxin, coupled with the high unmet medical need for new therapeutic options for patients diagnosed with TNBC, support our selection of TNBC as one of the initial indications for Supinoxin in the upcoming proof-of-concept Phase Ib/IIa clinical trial." "There is an accumulating body of in vitro and in vivo evidence suggesting a potential role for Supinoxin in the treatment of TNBC – a particularly aggressive and often difficult-to-treat form of breast cancer, which comprises approximately 20% of new breast cancer diagnoses," said Dr. S. Gail Eckhardt, Professor and Co-Division Head, Division of Medical Oncology, University of Colorado. "With a novel mechanism of action that appears to selectively bind to phosphorylated p-68, which is overexpressed in a range of human cancers – including TNBC – Supinoxin holds promise as a next generation, targeted anti-cancer therapy. We are pleased that Rexahn has selected TNBC as one of the initial indications for clinical evaluation in the proof-of-concept Phase Ib/IIa clinical trial and look forward to participating in this study." Rexahn has previously presented data demonstrating the ability of Supinoxin to dose-dependently decrease the migration of human triple negative breast cancer cells (MDA-MB-231) in a preclinical model of cancer cell metastasis, suggesting a potential role for Supinoxin in the prevention of cancer metastasis. In the latest study, the results of which were presented at the 2016 TAT Congress, Rexahn's scientific collaborators demonstrate the anti-proliferative effects of Supinoxin in multiple TNBC cell lines in which a high level of sensitivity to Supinoxin was observed in the majority of TNBC cell lines, suggesting broad activity of Supinoxin across various molecular subtypes of TNBC. These results are further supported by in vivo studies in which Rexahn scientists have shown potent tumor inhibition effects of Supinoxin in preclinical xenograft mouse models of TNBC. The results from the xenograft studies demonstrate that oral administration of Supinoxin inhibited tumor growth in a dose-dependent manner, with meaningful tumor growth inhibition of greater than 60% at higher doses and the achievement of complete responses and tumor free survival in mice. Supinoxin is currently being evaluated in a Phase I, open-label, multicenter study in patients with relapsed or refractory solid tumors. Rexahn plans to commence a Phase Ib/IIa clinical study to evaluate the safety and efficacy of Supinoxin in patients with TNBC and Relapsed/Refractory ovarian cancer.