World's First Cancer Vaccine Approved; Expect Interest in Antigenics, Dendreon

The tiny biotechnology company Antigenics Inc (NASDAQ:AGEN) said on Tuesday that it has won approval to market its kidney cancer vaccine, Oncophage, in Russia, making it the only cancer vaccine available in the world.

The product was approved despite failing to win approval in the United States. It is the first time the Russian government has approved a foreign drug that was not first cleared in its country of origin, Antigenics said. Antigenics is also planning to file for approval of the vaccine in Europe by the end of the year.

Notablecalls: Phew! This is unbelievable! The world's 1st cancer vaccine is approved. This is historic. I expect to see some buy interest in other cancer vaccine names, mainly Dendreon (NASDAQ:DNDN).

Comments

[John Walter:]

A couple points-of-fact:

Oncophage is hardly the first vaccine against cancer. I think that the US approved Gardisil (a vaccine against the human papillomavirus (HPV)) in 2006 or 2007; it's currently being marketed like crazy. It is claimed to prevent most, but not all, cervical cancers.

It's no surprise Oncophage wasn't approved by FDA...it ,a href="seekingalpha.com/artic...">failed its Phase 3 trial!

2008 Apr 08 01:29 PM

[PepsPicks:]

Gardisil is a vaccine for HPV but doesn't treat the cancer once it has been detected. I do think this is truely historic! I do think it is a matter of time before Oncophage is approved in the US. Antigentics seems to be a sleeping giant. I am all over this one.

2008 Apr 08 03:42 PM

[silverdog:]

FDA did not approve Ph.3 due to oncophage failing to meet the FDA's limited definition of what constitutes a cancer vaccine. This is due to oncophage being produced from the cancer cells themselves. In very general terms, then, the FDA would not have approved oncophage even if oncophage held 100% efficacy because there was no FDA category for evaluating Antigenics novel approach to fighting cancer. Under new guidelines, the trial must be repeated to meet the FDA's newly created protocol for heat shock protein cancer vaccine trials.

2008 Apr 08 04:47 PM

[Laura P:]

B.S. These "vaccines" sound a lot sexier than they actually are. Dendreon and Antigenics are on the wrong path. Mark my words, in 5 years if they don't come up with something better they'll fall flat on their faces.

This is not to say that tumor immunotherapy does not have amazing potential.

I refer you to my post on Dendreon: biotechforkicks.wordpr.../

2008 Jun 25 07:00 PM