ONCY~ FDA has granted REOLYSIN®, for the CANCERS treatment
Announces Receipt of Orphan Drug Designation from the U.S. FDA for Primary Peritoneal Cancer
CALGARY, March 3, 2015 /CNW/ - Oncolytics Biotech® Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN®, for the treatment of primary peritoneal cancers. The designation was granted on the basis of the Company's December 2014 application for an Orphan Drug Designation encompassing ovarian, fallopian tube and primary peritoneal cancers which are generally treated as one indication. On February 11, 2015, the Company announced that it had received Orphan Drug Designation for ovarian cancer and for cancers of the fallopian tube on March 2, 2015.
"This is the fourth indication for which we have received Orphan Drug Designation in the United States, and the third in a gynecological cancer indication," said Dr. Brad Thompson, President and CEO of Oncolytics. "These Orphan Drug Designations are an important step for Oncolytics' ongoing program to develop and commercialize REOLYSIN® as a therapeutic for targeted cancer patient populations."
Oncolytics has supported two sponsored clinical studies assessing REOLYSIN® in the treatment of peritoneal cancers. The first was a Phase 1/2 clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of REOLYSIN® that provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells. The second is an ongoing randomized Phase II trial (GOG186H) of weekly paclitaxel versus weekly paclitaxel with REOLYSIN® in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The second trial completed enrollment in September 2014.
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit: http://www.fda.gov/forindustry/DevelopingProductsforrareDiseasesConditions/default.htm.
News 
Market Data 
Discover 
AI
