Russian Roulette Pays Off for Antigenics

Tuesday morning, a little biotech company, Antigenics (AGEN), announced that Russia has approved its kidney cancer drug, Oncophage. It's the first so-called therapeutic cancer vaccine to win full-out approval anywhere in the world.

This is not a traditional preventive vaccine where you'd get a shot to stave off coming down with something. Therapeutic means you'd unfortunately have to get the cancer first and then your own cells are mixed with the "vaccine" to empower your body's immune system to fight off the disease.

I'm not trying to sound overly simplistic, but I know that the field of therapeutic cancer vaccines is complex and somewhat controversial.

Anyway, 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.

It's not a huge market in terms of rubles or dollars, but it's a big, fast-growing, untreated population. 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." That means he believes the drug works on patients whose tumors are of a certain size and confined to the kidney and the fatty tissue around the organ. If it has spread, then this drug, he said, is not for you. Dr. Wood says he and his colleagues have just submitted the study for possible publication in a major, but unidentified, peer-reviewed medical journal. That could give the drug even more cred.

There are many companies working on various types of therapeutic cancer vaccines. The most famous is Dendreon (DNDN). Please keep in mind many of these stocks are micro caps, but some of the others are Cell Genesys (CEGE), Geron (GERN), Vical (VICL), and Favrille (FVRL).

Please don't email me if I left your favorite trade off that partial list. And if you're wondering if Americans will be able to go to Russia for Oncophage treatment, Antigenics Chairman and CEO Garo Armen told me he doesn't know yet if, or how, that might work.

Update: The Antigenics story, of course, is making big news in Russia. It's the top story, for example, on this news web site. According to our Senior Economics Correspondent Steve Liesman--who used to live and work in Russia where he won a Pulitzer for his reporting--the headline says, "Russia becomes the first country in the world to sell an American cancer vaccine."

Comments

[kelatious]

Good for Russia....at least common sense still exists somewhere in the world. It's too bad the FDA doesn't have any.

[Georealist]

Of course..we don't know if its a vaccine..or a wanna be vaccine. We don't know what its clinical trials looked like in the United States because of a lack of article information. We don't know that the Russians approved this drug--whatever that means in Russia--for the publicity or merely to make money at unfortunate people's expense. Although...given the high regard in which Russia holds consumer protections and rights I'm sure its a fabulous drug....

[Afthought]

I guess Big Pharma has not managed to bribe the right people in the Russian drug approval process. Their problem is that US methods of persuasion do not transfer to the Russian economy. Maybe DNDN, etc. will wise up and take their research someplace other than the US so that their products can be delivered to people who so desparately need them in order to survive.

[dslnbull]

DNDN should try to get approval from russia, india middle east....American can fly get treatment.They can boost their economy.