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Reolysin Receives ‘Orphan Drug’ Designation for Ovarian Cancer
The FDA has granted an “orphan drug” designation for Reolysin (Oncolytics Biotech) for the treatment of ovarian cancer.
Reolysin is a proprietary variant of the reovirus (an acronym for “respiratory enteric orphan virus”), which is widely found in the environment. By adulthood, most people have been exposed to the reovirus. The virus is non-pathogenic, which means that infections are typically asymptomatic.
Reolysin was well-tolerated in clinical trials, with patients exhibiting only mild, flu-like symptoms. The treatment has been used alone and in combination with chemotherapy and radiotherapy for various cancers, including head-and-neck cancers in an ongoing phase III clinical trial.
Two studies have assessed Reolysin in the treatment of ovarian cancer. The first was a phase I/II clinical trial involving patients with metastatic ovarian, peritoneal, or fallopian-tube cancer treated with concurrent intravenous and intraperitoneal Reolysin. This study provided evidence of viral targeting of and replication in peritoneal and ovarian cancer cells.
The second study is an ongoing randomized phase II trial of weekly paclitaxel compared with weekly paclitaxel and Reolysin in patients with persistent or recurrent ovarian, fallopian- tube, or primary peritoneal cancer. This study completed enrollment in September 2014.
The FDA grants “orphan drug” status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The agency defines rare diseases as those affecting fewer than 200,000 people in the U.S. at any given time. The receipt of an “orphan drug” designation does not change the regulatory requirements or process for obtaining marketing approval.
The American Cancer Society estimates that 21,908 American women will be diagnosed with ovarian cancer and that an estimated 14,270 will die from the disease in 2014. Approximately 193,203 patients are affected with ovarian cancer at any time in the U.S. The disease accounts for approximately 5% of all cancer deaths among women. The prognosis for patients diagnosed with ovarian cancer at the localized stage is good, with a 5-year survival rate of 92%; however, only about 15% of cases are diagnosed at this stage. The relative 10-year survival rate for all stages combined is approximately 35%.