Antigenics’ Kidney Cancer Drug Oncophage Gets Clearance in Russia

By Anna Boyd
15:45, April 8th 2008
67 votes
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Antigenics’ Kidney Cancer Drug Oncophage Gets Clearance in Russia

New York-based biotechnology company Antigenics Inc. announced Tuesday that it has won approval to market its cancer vaccine, Oncophage, in Russia for the treatment of kidney cancer patients at intermediate risk of disease occurrence.

Oncophage is designed to reprogram the body’s immune system to target only cancerous cells bearing antigenic fingerprint. The vaccine is derived from each individual’s tumor and contains the antigenic fingerprint of the patient’s particular cancer.

According to its manufacturer, the use of Oncophage would avoid the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy.

The Russian approval was given despite the company failing to win approval in the United States. In fact, it is the first time when the Russian government has approved a drug that did not get clearance in its country of origin, Antigenics said, according to Reuters.

Antigenics expects to launch Oncophage in Russia in the second half of the year. In addition, it hopes to file for conditional approval of the vaccine in Europe this year. European regulators offer conditional approval to a drug when companies marketing it simultaneously conduct additional follow-up of patients or further clinical studies.

According to the International Agency for Research on Cancer, there were about 16,329 new cases of kidney cancer in Russia in 2004, and about 10,872 people died from the disease. Renal cell carcinoma accounts for about 90 percent of all kidney tumors, and by the time it is diagnosed, about one third of patients will have developed metastatic disease.



Image Credit: www.antigenics.com
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