Oncophage® is a cancer vaccine intended for the treatment of glioma, the clinical term for a tumor that most commonly appears in the brain. It is also intended for treating kidney cancer and metastatic melanoma, the latter being a form of skin cancer. Oncophage® originated as a better alternative to cancer treatments such as chemotherapy, which can destroy healthy tissue and cause serious side effects such as nausea, vomiting and sexual impotence.
Glioma, named after its origin from glial cells, can be a frightening prognosis. This is mainly because there is no known cause of the medical condition, and it occurs most frequently out of all the different kinds of brain cancers. Moreover, at a period of three to six months after conclusion of treatment, glioma has a poor median survival rate. The National Cancer Institute in the United States estimates that 19,000 U.S. citizens are affected with glioma per year.
Oncophage® is called a personalized vaccine, based on the way it works to fight glioma. The drug takes a chaperone protein called heat shock protein 90kDa beta member 1 (gp96) from a patient's tumor and turns his or her immune system against the cells that possess that identifier. This treatment was introduced in April 2008, when Russia started using it for patients with early-stage kidney cancer and who were at risk for redeveloping the disease. Six months later, the drug's manufacturer, Antigenics, Inc., approached the European Medicines Agency (EMEA) with a marketing authorization application to seek conditional approval for Oncophage®'s use in renal cancer. The EMEA granted that request in March 2009.
In the meantime, Antigenics was working on Oncophage®'s Phase I clinical trial, which took place at the University of California, San Francisco's Brain Tumor Research Center. The final results of the trial revealed that the overall median survival rate was increased from a peak of six months to nearly 11 months. Some of the tested patients cleared the 12-month mark and one almost made it to three years.
Such progress convinced the World Vaccine Congress to name Oncophage® as the best therapeutic vaccine in April 2009. A month later, the U.S. Food and Drug Administration {FDA} followed the lead of the EMEA by granting orphan drug status to Oncophage® as a treatment for glioma in May 2009. As of February 2011, however, Russia remains the only country in the world to approve the cancer vaccine.