Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company announced today the commencement of patient dosing with Supinoxin TM (RX-5902) in a Phase I clinical trial designed to study safety and efficacy in patients with solid cancer tumors.
Supinoxin is an orally administered, first-in-class, small molecule inhibitor of phosphorylated-p68 RNA helicase (P-p68). P-p68, which is selectively expressed in cancer cells and is absent in normal tissue, increases the activity of multiple cancer related genes including cyclin D1, c-jun and c-myc, and plays a role in tumor progression and metastasis. Over-expression of P-p68 has been observed in solid tumors, such as melanoma, colon, ovarian and lung.
The Supinoxin Phase I trial is a multi-center dose-escalation study which will evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) in patients with solid tumors. Secondary endpoints will include characterizing the pharmacokinetic profile of Supinoxin and evaluating the preliminary anti-tumor effects of Supinoxin.
Dr. Joe J. Stephenson, MD, Medical Director, Institute for Translational Oncology Research (ITOR), Greenville Health Systems commented, “Supinoxin represents a very interesting new approach for the treatment of cancer patients with solid tumors. We are excited about investigating its potential as a novel therapy in cancer patients.”Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer commented, “The start of Supinoxin dosing represents an important milestone for Rexahn. Supinoxin is Rexahn’s third oncology compound to enter into clinical development and represents an important part of our expanding clinical development pipeline.” In preclinical studies Supinoxin has been shown to inhibit proliferation of cancer cells in 18 human cancer cell lines including breast, colon, pancreas, ovarian, and stomach cancers, and showed potent activity in drug-resistant cancer cells. In an animal model, where human cancer cells from melanoma, pancreas, renal or ovarian cancers were grafted into animals, treatment with Supinoxin resulted in a significant reduction in tumor growth.