Shares of Oncolytics Biotech (TSX:ONC, Nasdaq:ONCY) are up today after the company announced that the FDA had granted orphan drug designation lead product candidate, Reolysin, which is designed to treat various cancers. Today’s status relates to the treatment of pancreatic cancer.
“This is the second indication for which we have received orphan drug designation in the United States,” said CEO Dr. Brad Thompson. “The prognosis for pancreatic cancer is typically poor, and it is critical to expand the range of treatment options available to these patients.”
The Orphan Drug Designation program provides orphan status to drugs that are aimed at treating rare diseases or disorders, defined by the FDA as affecting fewer than 200,000 people. Orphan status may be given to drugs that affect more than 200,000 people but have no reasonable expectation of recouping development and marketing costs.
On February 12th, Reolysin was been granted orphan drug designation by the FDA for the treatment of ovarian cancer.
Last September, shares of Oncolytics fell after a U.S. National Cancer Institute sponsored study showed that progression free survival, the length of time during or after medication that a patient’s cancer does not get any worse, was virtually identical between the REOLYSIN arm and a control arm in patients with recurrent or metastatic pancreatic cancer.
At press time, shares of Oncolytics Biotech on the TSX were up 33.3% to $0.84.