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Reolysin Receives ‘Orphan Drug’ Designation for Treatment of Fallopian Tube Cancer
The FDA has granted an “orphan drug” designation to Reolysin (Oncolytics Biotech, Inc.) for the treatment of cancer of the fallopian tube. The designation was granted on the basis of a December 2014 application for “orphan drug” status encompassing ovarian, fallopian tube, and primary peritoneal cancers, which are generally treated as one indication.
In February 2015, Reolysin received an “orphan drug” designation for 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 reovirus is nonpathogenic, which means that infections are typically asymptomatic.
Reolysin has been well-tolerated in clinical studies, with patients exhibiting mild, flu-like symptoms. Reolysin has been used alone and in combination with chemotherapy and radiotherapy for the treatment of various cancers, including head-and-neck cancers, in an ongoing phase III study.
In clinical research, it was found that the reovirus was able to infect and selectively destroy cancer cells. When a normal cell is infected with the reovirus, an antiviral response is activated, which prevents the virus from replicating within the cell. However, inside a cancer cell with one or more mutations on the Ras growth pathway, an aberrant antiviral response is unable to prevent the virus from replicating. This abnormality allows the reovirus to multiply to an extent that is fatal to the cancer cell.
Two clinical studies have assessed Reolysin in the treatment of cancer of the fallopian tube. The first was a phase I/II trial in patients with metastatic ovarian, peritoneal, or fallopian tube cancer using concurrent intravenous and intraperitoneal administration of Reolysin. This study provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells. The second trial is an ongoing randomized phase III study of weekly paclitaxel and Reolysin compared with weekly paclitaxel alone 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 companies 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. An “orphan drug” designation provides drug companies certain benefits and incentives, including a period of marketing exclusivity, potential tax credits for certain activities, eligibility for “orphan drug” grants, and the waiver of certain administrative fees.
The incidence rate of fallopian tube cancer is estimated to be 0.37 per 100,000 women. Approximately 15,750 women have fallopian tube cancer at any time in the U.S. The median survival period for women in the U.S. with fallopian tube cancer is slightly less than 5 years.