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Oncolytics REOLYSIN seeks US FDA orphan drug status to treat gastric cancer

 

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Oncolytics Biotech Inc., a biotechnology company concentrated on the development of oncolytic viruses as potential cancer therapeutics. Company has presented an application to the US Food and Drug Administration (FDA) for REOLYSIN to get Orphan Drug Designation for the treatment of gastric cancer.

Stomach cancer or gastric cancer is cancer developing from the lining of the stomach. he cancer may spread from the stomach to other parts of the body, particularly the liver, lungs, bones, lining of the abdomen and lymph nodes.Patients diagnosed with later stage gastric cancer generally have very poor prognoses. Gastric cancer is a serious issue both in the United States and other countries around the world. This product will be hepful to caught early-stage stomach cancerduring preparation for gastric bypass surgery

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.  The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. Orphan Drug Designation  program provides funding for clinical research that tests the safety and efficacy of drugs, biologics, medical devices and medical foods in rare diseases or conditions. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.

The American Cancer Society estimates that 24,590 Americans will be diagnosed with gastric (stomach) cancer and in 2015 an estimated 10,720 Americans are expected to die from the disease. The relative five-year survival rate for all stages combined is approximately 28 per cent.


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