Rexahn Begins Solid Tumor Trial

Rexahn Pharmaceuticals has initiated a Phase Ib clinical trial to study the safety and efficacy of RX-3117 in cancer patients with solid tumors. The trial is a multi-center dose-escalation study that will evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) of RX-3117 in patients with solid tumors. Secondary endpoints will include characterizing the pharmacokinetic profile of RX-3117 and evaluating the preliminary anti-tumor effects of RX-3117.

RX-3117 is a next-generation cancer cell specific drug candidate that possesses a broad spectrum of anticancer activity with reduced side effects. In an exploratory Phase I clinical trial conducted in Europe, RX-3117 demonstrated oral bioavailability, and safety and tolerability in cancer patients with solid tumors. The compound has shown efficacy in human cancer cell lines resistant to gemcitabine.

The trial is expected to enroll as many as 30 patients from multiple sites in the U.S. Patients will receive RX-3117 orally three times a week for three weeks followed by one week off, and will have the ability to continue on the drug for as many as eight cycles of treatment. The decision to enroll the next group of patients and escalate the dose will be made after one cycle of treatment, based on safety and tolerability. Patients will be assessed for tumor progression by CT or MRI prior to the start of therapy and after every two cycles of therapy. Rexahn expects to complete enrollment of patients by the end of 2014, and data is expected in 1H15.