Apr 8, 2008 - Antigenics Inc. today announced that the Russian Ministry of Public Health has issued a registration certificate for the use of Oncophage(R) (vitespen) in the treatment of kidney cancer patients at intermediate risk for disease recurrence. The company expects to launch Oncophage in Russia in the second half of 2008.
"The registration of Oncophage in Russia represents an important treatment advancement for patients with intermediate-risk kidney cancer," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "We are very pleased that Oncophage is the first personalized cancer vaccine that will be available in any major country. Additionally we hope to file for the conditional approval of Oncophage in Europe this year."
"The current standard of care for patients with nonmetastatic renal cell carcinoma consists of surgical removal of the kidney followed by observation," commented Professor Vsevolod Matveev of N.N. Blokhin's National Cancer Research Center of RAMS, Moscow. "Following surgery, these patients often request treatment options to help prevent or delay recurrence of their disease. This registration means patients in Russia with earlier-stage disease will now have Oncophage as a treatment option."
To comply with US regulations for exporting biologics, Antigenics applied for an export license from the US Food and Drug Administration (FDA). The company expects the FDA to take action on the license application within approximately 60 days of submission.
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