Oncolytics Newest Orphan Drug Designation

By Chris Lange Updated Apr 28, 3:09AM EDT · Published Mar 3, 2:47PM EST

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Oncolytics Biotech Inc. (NASDAQ: ONCY) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation for Reolysin. Reolysin is the company’s lead product candidate that is designated for the treatment of primary peritoneal cancers. It’s worth noting that Oncolytics keeps getting orphan drug designations for this and other compounds.

Oncolytics has supported two sponsored clinical studies assessing Reolysin in the treatment of peritoneal cancers. One study was a phase 1/2 clinical trial for patients with metastatic ovarian, peritoneal and fallopian tube cancers. This study used concurrent intravenous and intraperitoneal administration of Reolysin, resulting in evidence of viral targeting and replication in peritoneal and ovarian cancer cells.

The second study is an ongoing randomized phase 2 trial, testing weekly paclitaxel versus weekly paclitaxel with Reolysin in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. This trial completed its enrollment last September.

Dr. Brad Thompson, President and CEO of Oncolytics, said:

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. 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.

Recently, Oncolytics has received a few other Orphan Drug Designations for Reolysin. On February 9 Reolysin received a designation for the treatment of high grade gliomas in pediatric patients. Just a couple of days later Reolysin was granted Orphan Drug Designation for the treatment of ovarian cancer. Then on February 17 and 18, the FDA granted Reolysin a designation for the treatments of pancreatic cancer and colorectal cancer.

Shares of Oncolytics were up 8% at $1.16 in the second half of the trading day. The stock has a consensus analyst price target of $3.81 and a 52-week trading rnage of $0.40 to $2.07.

About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.