Oncolytics Biotech Inc. (ONCY) announced that its lead candidate, Reolysin has been granted orphan drug designation by the FDA for the treatment of ovarian cancer.
We note that the FDA usually grants orphan drug status to novel candidates or biologics that are being developed as a potential treatment for rare diseases/conditions affecting less than 200,000 people in the U.S. at any given time. This designation allows the product to enjoy a period of marketing exclusivity in the U.S., upon approval.
Moreover, Oncolytics is now eligible to receive benefits like tax credits for research and development costs, annual grant funding as well as request for the waiving of certain administrative fees. However, orphan drug status does not alter the regulatory process for obtaining marketing approval for the candidate.
Currently, Reolysin is being studied in a randomized phase II third-party trial (GOG186H), comparing the weekly dosage of Taxol with Reolysin plus Taxol for the treatment of patients suffering from persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. Patient enrolment in this study was completed in Sep 2014. Meanwhile, a phase I/II study (OSU-07022) evaluated concurrent intravenous and intraperitoneal administration of Reolysin for the treatment of patients suffering from metastatic ovarian, peritoneal and fallopian tube cancers. This study showed that the candidate is capable of viral targeting and replication in peritoneal and ovarian cancer cells.
According to the American Cancer Society, 193,203 patients are estimated to suffer from ovarian cancer at a given point of time. In 2014, 21,908 American women have been estimated to be diagnosed with ovarian cancer with 14,270 expected to die from the disease. Notably, ovarian cancer accounts for almost 5% of all cancer-related deaths in women.
We remind investors that Oncolytics is also seeking orphan drug status for Reolysin for the treatment of ovarian cancer in the EU. Additionally, the company has submitted applications seeking orphan drug status for Reolysin for high-grade gliomas (pediatric patients) in the U.S. and pancreatic cancer in the U.S. and the EU.
Reolysin is being developed for several indications including lung, colorectal, prostrate and breast cancer. Since it is Oncolytics’ lead candidate, we expect investor focus to remain on further updates on the company’s pipeline.
Oncolytics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include BioMarin Pharmaceutical Inc. (BMRN), Biogen Idec (BIIB) and Alnylam Pharmaceuticals, Inc. (ALNY). While BioMarin carries a Zacks Rank #1 (Strong Buy), Biogen and Alnylam hold a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment