Oncolytics’ Reolysin Receives Orphan Drug Designations from the FDA

Oncolytics Biotech Inc.’s lead product candidate Reolysin was granted orphan drug designation for two types of cancer this week.

The company announced Monday that the US Food and Drug Administration (FDA) granted the drug orphan drug designation for Reolysin for the treatment of cancer of the fallopian tube. On Tuesday, the company followed up the announcement with news that the agency has also granted orphan drug designation for Reolysin for the treatment of primary peritoneal cancers. Reolysin has now been granted orphan drug status for four indications.

The designations were granted on the basis of the company’s application for Orphan Drug designation encompassing ovarian, fallopian tube and primary peritoneal cancers submitted in December. These cancers together are generally treated as one indication. In addition to primary peritoneal cancers and cancer of the fallopian tube, in February, Reolysin received orphan drug designation in both ovarian cancer and pancreatic cancer.

“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.”

The company has supported two sponsored clinical studies of Reolysin. In the Phase I/II study, OSU-07022, Reolysin was studied in 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 ongoing Phase II trial, GOG186H, evaluated weekly paclitaxel versus weekly paclitaxel with Reolysin in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. This study completed enrollment in September.

The incidence rate of fallopian tube cancers is estimated to be 0.37 per 100,000 women. At any time in the US, approximately 15,730 patients are affected with the disease. The median survival of women in the US with fallopian tube cancers is 58 months, or just under five years. Primary peritoneal cancers is estimated to affect 0.68 per 100,000 women. Approximately 16,250 patients are affected with primary peritoneal cancers at any time in the US. Women in the US with primary peritoneal cancers have a median survival of 33 months, or just under three years.

Source: Oncolytics Biotech Inc.

Last updated: 3/3/15; 11:15am EST

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