Oncolytics Biotech, Inc. (USA)(NASDAQ:ONCY) reported that the FDA has given orphan drug status to its lead drug candidate Reolysin. The drug is deigned to treat pancreatic cancer. Dr. Brad Thompson, the CEO said that it is the second indication for which the company has received orphan drug status in the U.S. The diagnosis for pancreatic cancer is extremely poor, and therefore it is vital to expand the treatment alternatives for patients suffering from pancreatic cancer.
The Orphan Drug Designation plan grants orphan status to those drug candidates that are aimed at treating most severe and rare disorders or diseases, as defined by the FDA. Orphan designation can be given to lead product candidates that affect over 200,000 people. However, these drugs should have no expectation of recouping development and marketing expenses. Prior to this, Reolysin was granted orphan drug status by the FDA to treat ovarian cancer.
In September 2014, shares of Oncolytics Biotech, Inc. (USA)(NASDAQ:ONCY) declined after a study showed that progression free survival and the condition of patient’s cancer was almost identical between a control arm and the Reolysin arm in patients suffering from metastatic or recurrent pancreatic cancer. The study evaluated experimental therapy of Oncolytics in which Reolysin was given in combination with paclitaxel against a control arm. The comparative control arm included paclitaxel and carboplatin.
The length of time fir Reolysin arm and the control arm came at 5.26 months and 5.16 months respectively. Oncolytics Biotech, Inc. (USA)(NASDAQ:ONCY) also conducted a different test on a group of patients with a gene mutation. In this experiment, the Reolysin drug showed a better progression free survival time of 5.72 months against the control’s arms duration of 4.11months.
Oncolytics has received orphan drug designation for Reolysin for treatment of ovarian cancer and pancreatic cancer. Oncolytics Biotech, Inc. (USA)(NASDAQ:ONCY) is testing the potential benefits of Reolysin in treating various forms of cancer.