Dr. Brad Thompson reports

ONCOLYTICS BIOTECH INC. ANNOUNCES RECEIPT OF ORPHAN DRUG DESIGNATION FROM THE U.S. FDA FOR CANCER OF THE FALLOPIAN TUBE

The U.S. Food and Drug Administration has granted orphan drug designation for Oncolytics Biotech Inc.'s lead product candidate, Reolysin, for the treatment of cancer of the fallopian tube. 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 Feb. 11, 2015, the company announced that it had received orphan drug designation for ovarian cancer.

"The FDA's recognition of ovarian and fallopian tube cancers as distinctly separate indications paves the way for a more targeted approach to the treatment of gynecological cancers," said Dr. Brad Thompson, president and chief executive officer of Oncolytics. "We are pleased to have secured our third orphan drug designation in the United States and look forward to continuing our development and commercialization program for Reolysin."

Oncolytics has supported two sponsored clinical studies assessing Reolysin in the treatment of cancers of the fallopian tube. 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 a continuing 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 enrolment 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.

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