1st cancer vaccine approved in Russia

A New York-based biotech company announced today (April 8) that it has received approval for the first linkurl:therapeutic cancer vaccine;http://www.the-scientist.com/article/display/18859/ -- in Russia. It is the first approval by a regulatory body of a cancer immunotherapy. The therapy's approval in Russia won't in itself boost its chances for approval in the US or the EU, or improve the prospects of other cancer vaccines that are in the biotech pipeline, Ren Benjamin, senior biotech analyst

By | April 9, 2008

A New York-based biotech company announced today (April 8) that it has received approval for the first linkurl:therapeutic cancer vaccine;http://www.the-scientist.com/article/display/18859/ -- in Russia. It is the first approval by a regulatory body of a cancer immunotherapy. The therapy's approval in Russia won't in itself boost its chances for approval in the US or the EU, or improve the prospects of other cancer vaccines that are in the biotech pipeline, Ren Benjamin, senior biotech analyst at the New York investment firm Rodman and Renshaw told The Scientist. But Russia is "novel ground" for small biotech, he said: Seeking first approval in a country outside of the US and EU is a bold move, and both biotech companies and investors will be closely watching to see how lucrative a market Russia turns out to be. The antibody-based therapy, Oncophage, received a registration certificate from the Russian Ministry of Public Health to treat a subset of kidney cancer patients who are at intermediate risk for disease recurrence, the company, Antigenics, said in a linkurl:press release;http://www.antigenics.com/news/2008/0408.phtml. The treatment, made from patients' tumor cells, increased recurrence-free survival by 1.7 years according to the results of a phase III clinical trial, the release said. Cancer immunotherapy has long been a field riddled with scientific challenges, and as we reported in 2006, linkurl:Antigenics' vaccine;http://www.the-scientist.com/article/display/24100/ was no exception. The company's phase III study in patients with nonmetastatic kidney cancer did not meet its primary endpoint, the company reported last year. Further analysis revealed that the treatment did seem to work for a subgroup of patients who had a lesser risk of recurrence. But such post-hoc analysis isn't enough for the FDA, which has already said that Antigenics needs to conduct a new trial looking explicitly at this patient group. "I think that linkurl:other [cancer vaccine] companies;http://www.the-scientist.com/article/display/14841/ in the past -- main one being Dendreon -- have gotten phase III trial results that have shown promise in a subset of patients," said Benjamin. "However, no one has been entrepreneurial enough to seek registration in a country like Russia." According to linkurl:recent reports,;http://money.cnn.com/2008/04/02/news/companies/pharma_russia/index.htm?postversion=2008040412 he noted, the pharma market there is growing astronomically. "This will really be a landmark analysis -- not only to see whether small biotechs can do it alone in these other countries, but also, are these other countries worth pursuing," he said. Meanwhile, Christopher Wood, a cancer researcher at MD Anderson Cancer Center who led the Oncophage trial, linkurl:told CNBC;http://www.cnbc.com/id/24010964 that the company had assured him they plan to use proceeds from Russian sales to fund a study for FDA approval. Wood also noted that the data has been submitted for publication. (Wood wasn't available to comment by the time I posted this blog.) Antigenics is also looking into approval in the European Union based on its current data.
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Comments

Avatar of: anonymous poster

anonymous poster

Posts: 1

April 10, 2008

Melacine from Corix was approved by the Canadian authorities before Antigenic's product. I appreciate that Melacine has since been discontinued in the US and EU, but technically, this was approved beforehand.
Avatar of: PRASANTA GHOSH

PRASANTA GHOSH

Posts: 9

April 14, 2008

This is indeed, a step in the right direction when kidney cancer cure is yet in peril. This shall boost the development of several such products to treat presently incurable diseases like HIV, HBV and HCV. Several promising approaches exist that do not get easy acceptance, as such substances do not guarantee a cure. The differential gain is often discounted because there could be unanswered issues such as inadequacy of the animal model as in anti- HIV drug development , or unresolved questions of safety emanating from the development of non-neutralizing antibodies from the use of agents that promote synergy to other medicaments. But to have the dearest ones a few more years before us is certainly a welcome step for all.

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