Oncolytics climbs on Reolysin orphan drug status in Europe

10:53 am by Deborah Bacal

The grant represents the second jurisdiction where the company has gained orphan status for the use of Reolysin to treat gynecological cancers after the U.S.

Shares of Oncolytics Biotech (TSE:ONC) (NASDAQ:ONCY) jumped in early trades after the biotech firm announced that European regulators have granted its lead product candidate, Reolysin, orphan drug designation for the treatment of ovarian, fallopian tube and primary peritoneal cancers.

The grant represents the second jurisdiction where the company has gained orphan status for the use of Reolysin to treat gynecological cancers after the U.S.

"We continue to secure Orphan Drug Designation for selected cancers as a way to support further development of Reolysin in key jurisdictions globally," said president and chief executive officer, Dr. Brad Thompson, in a statement.

Orphan drug designation in Europe means that sponsors can access several incentives, including protocol assistance, market exclusivity for a 10-year period and potential fee reductions. The designation, which is granted for medicines to treat life threatening disease, does not change the regulatory requirements or process for obtaining market approval.

Reolysin is the company's proprietary isolate of the reovirus, whose primary mode of activity is to infect and selectively target tumours with Ras pathway mutations and/or over-expressions of Ras pathway elements, a common feature of many cancers.

Ovarian cancer affects about 150,000 women at any given time in the EU, and has a prevalence of approximately 3 per 10,000.

In addition to gynecological cancers, Oncolytics has also been granted orphan drug status in the U.S. for Reolysin for pancreatic cancer.

Shares of the Calgary, Alberta-based company were last up 8.3 percent at C$1.05 on Wednesday, stretching year-to-date gains to over 64 percent.