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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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