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Tuesday, April 08, 2008

Antigenics Oncophage Cancer Treatment Approved in Russia

Today Antigenics Inc. (NASDAQ: AGEN ) announced that the Russian Ministry of Public Health has issued a registration certificate for the use of Oncophage® (vitespen) in the treatment of kidney cancer patients at intermediate risk for disease recurrence. Antigenics expects to launch Oncophage in Russia in the second half of 2008.

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Oncophage is a personalized vaccine made from cells taken from a patient's malignant cancer tumor. It 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.

“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.”

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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Last year I reported (Insider Buying at AGEN by Chairman and CEO Garo H. Armen) insiders bought AGEN at $1.93 a share in February 2007 . I also disclosed I owned AGEN in my personal portfolio and I bought 1,000 shares on the Feb 9, 2007 news.

The stock rallied soon after to over $5 a share then returned to the area of our purchase at $1.95 in late 2007 before the latest news has it jumping again.

About today's news, CNBC's Mike Huckman reported:

  • ... a test showed that a subset of patients on Oncophage lived 1.7 years longer without the cancer coming back. But because the clinical trial didn't meet its main goal and the aforementioned benefit was only discovered in a re-analysis of the data, the drug didn't pass muster with the Food and Drug Administration.
  • The agency wanted AGEN to do a bigger, longer and expensive study. But like most baby biotechs, Antigenics didn't have that kind of cash. So, the company turned to Russia where it had enrolled 125 patients in the same clinical trial. And after a 10-month process, AGEN won approval of the drug there making Russia the first country in the world to allow a therapeutic cancer vaccine onto the market.
  • The lead clinical trial investigator, Dr. Christopher Wood at the MD Anderson Cancer Center, says the company has given him verbal assurances that it will use the Russian revenue to pay for another study here that might eventually satisfy the FDA. Dr. Wood, an associate professor of urology and cancer biology, says he doesn't own AGEN stock--he just consults for Antigenics and ran the clinical trial.
  • Over the phone he told me, "Absolutely no question about it (that the drug works). I've looked at the data," he said, "and there's clear activity in the intermediate risk subgroup."

I like the idea of a cancer vaccine treatment that targets the cancer cells while leaving the rest of the body alone. If this treatment works for one cancer, then in theory it should work for other cancers. I saw Dr. Dean Edell do a story on KGO TV7 about a patient with deadly brain cancer who was given an experimental drug therapy that was keeping her alive long past her "due date." The drug mentioned on the news story was "Oncophage."

Antigenics Inc. is one of those stocks I like to have some shares in my portfolio for the very long term with the hope it is successful for more than just a financial reward.

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  • I still own AGEN in my personal portfolio including the 1,000 shares purchased on the Feb 9, 2007 news.
  • I may trade the ups and downs of AGEN in either or both my personal and my newsletter explore portfolios without announcing it here or anywhere else unless I add it to my newsletter explore portfolio where I will announce trades to subscribers via email.

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