Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has completed its exploratory Phase I clinical trial of RX-3117 in cancer patients. The phase I study, which was conducted in Europe, had the primary objective of determining the oral bioavailability of RX-3117 in humans. The study demonstrated that RX-3117 is bioavailable when delivered orally to patients. There were no adverse events reported in this study.
Dr. Chang Ahn, Chief Executive Officer, Rexahn, stated, “This first in human clinical study confirms good bioavailability of RX-3117, a key differentiator of this exciting anti-cancer agent. As a potential future alternative to market leading antimetabolites, RX-3117 can be given by oral administration to potentially treat solid tumors in the colon, lung, bladder and pancreas. With these positive results, Rexahn and Teva will move the RX-3117 development program into the next phase.”
Prof. Dr. Godefridus J. (Frits) Peters, Head Laboratory Medical Oncology, VU University Medical Center, Amsterdam, the Netherlands, stated, “The results of this exploratory Phase I trial are really exciting and promising. RX-3117 has a novel and unique mechanism of action and different metabolism compared to other nucleoside analogs. Its oral bioavailability is unique for most antimetabolites and gives promise for future therapeutic development.”
In September 2009, Rexahn entered into a commercialization and development agreement with Teva Pharmaceutical Industries Limited for RX-3117. Under the agreement, Rexahn is eligible to receive development, regulatory and sales milestone payments, as well as royalties on net sales worldwide.
RX-3117 is a small molecule, new chemical entity (NCE) and nucleoside compound. Potential indications of RX-3117 are solid tumors including colon, lung and pancreatic cancers. In pre-clinical studies, RX-3117 demonstrated an ability to overcome cancer drug resistance in cancer cells, in particular, gemcitabine-resistance in human lung cancer cells. Rexahn has been awarded patents for RX-3117 in the United States, China, Europe, Korea, Mexico, and Japan.