A cancer vaccine is approved in Russia and investors are happy even if the FDA is not
Cancer vaccines have been very hard to come by. So when a New York-based biotech company, Antigenics, saw the results of its recent trial testing a vaccine for kidney cancer (Oncophage), enthusiasm was high. Even though the vaccine did not meet the primary end point of the trial, it did seem to work in a subset of the patients. But, the FDA, in its disputable wisdom, did not accept the finding and required the company to design and conduct a new Phase III trial. The company’s response? Get approval for the vaccine in Russia.
Could this be a new strategy for small
biotechs?
By Alla Katsnelson, April 9, 2008 on TheScientists.com
NewsBlog
A New York-based biotech company announced today (April 8)
that it has received approval for the first therapeutic cancer
vaccine -- in
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
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 press release 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, Antigenics' vaccine 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 other (cancer vaccine) companies 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
According to recent reports, 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, told CNBC 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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Further comments on the FDA’s response to Antigenics’
vaccine trial can be found on BiotechBlitz (April 10, 2008).
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