ROCKVILLE, Md., Sept. 24, 2014 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its drug RX-3117 for the treatment of patients with pancreatic cancer. RX-3117 is a next generation, cancer-specific nucleoside analog. Rexahn is currently enrolling patients in a Phase Ib clinical trial in cancer patients and expects to complete this trial in the first quarter of 2015.
The FDA’s office of Orphan Drug Products grants orphan status to support development of medicines for rare disorders, defined as diseases that affect fewer than 200,000 people in the United States. Orphan drug designation provides Rexahn with certain benefits, including limited market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.
Preclinical studies have shown that RX-3117 maintains its anti-tumor activity in human cancer cell lines that are resistant to gemcitabine, a chemotherapy drug used to treat pancreatic cancer. Gemcitabine resistance represents a major problem in the treatment of cancer patients. In pancreatic cancer patients who have been treated with gemcitabine, up to 40% of patients became resistant to gemcitabine after 30 days.
“Receiving Orphan Drug Designation for RX-3117 in the treatment of pancreatic cancer is an important milestone for this clinical development program,” commented Rexahn’s Chief Executive Officer Peter D. Suzdak, PhD. “RX-3117 has shown to be effective in treating cancer cells that have become gemcitabine resistant. If the results of our Phase Ib trial and future trials show similar results in gemcitabine resistant patients, this would represent a major breakthrough in the treatment of pancreatic cancer patients.”
