The U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to Reolysin®, an injectable cancer-killing virus, for the treatment of gastric cancer. Oncolytics Biotech® Inc. recently announced the designation in a press release.
The FDA grants ODDs in order to advance the evaluation and development of products that demonstrate promise for the treatment of rare diseases or conditions. The term rare diseases refers to diseases affecting fewer than 200,000 people in the United States at any given time.
Gastric cancer refers to cancer of the stomach. The American Cancer Society estimates that 24,590 Americans will be diagnosed with gastric cancer and an estimated 10,720 Americans are expected to die from the disease in 2015. The relative five-year survival rate for all stages combined is approximately 28%.
Reolysin is a form of human virus known as a reovirus that rarely causes symptoms. When injected into people with cancer, it’s demonstrated the ability to target and destroy cancer cells. In cancers with a certain type of pathway known as a Ras pathway, Reolysin replicates until the host cancer cell is overwhelmed and dies. It then moves on to the next cell. The therapy has been used alone and in combination with chemotherapy and radiation for various cancers.
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Reolysin has been well tolerated in clinical trials. Side effects tend to be limited to mild flu-like symptoms.
Reference: Oncolytics Biotech® Inc. Announces Receipt of Orphan Drug Designation from the U.S. FDA for Gastric Cancer [press release]. Oncolytics Biotech® Inc. website. Available at: oncolyticsbiotech.com/news/press-release-details/2015/Oncolytics-Biotech-Inc-Announces-Receipt-of-Orphan-Drug-Designation-from-the-US-FDA-for-Gastric-Cancer/default.aspx. Accessed May 11, 2015.