Antigenics cancer drug gets Russia OK

Shares of Antigenics Inc. spiked in Tuesday premarket trading, after the biotechnology company said its Oncophage treatment for kidney cancer patients was approved for use in Russia.

The drug is approved for patients with medium risk of cancer relapse. The company expects to launch Oncophage in Russia in the second half of 2008, and will file for European approval this year.

Made from each individual's tumor, Oncophage contains the 'antigenic fingerprint' of the patient's particular cancer and is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint.

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"The current standard of care for patients with nonmetastatic renal cell carcinoma consists of surgical removal of the kidney followed by observation," said 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."

Oncophage hasn't yet been approved outside of Russia. Oncophage has received fast track and orphan drug designations from the Food and Drug Administration for both kidney cancer and metastatic melanoma, and orphan drug status for kidney cancer from the European Medicines Agency.

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Renal cell carcinoma is the most common type of kidney cancer. 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.

Antigenics shares rose 56 cents, or 23 percent, to $3.03 in premarket electronic trading, having closed Monday at $2.47.