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Science Forum Index » Medicine - Cancer Forum » First cancer vaccine approved in Russia
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| J |
 Posted: Thu Apr 10, 2008 4:49 am |
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http://www.canada.com/globaltv/national/health/story.html?id=a4d9928f-91e5-49cc-8755-db92f980c2d2
First cancer vaccine approved in Russia
Toni Clarke, Reuters
BOSTON -- Russian regulators have approved the world's first cancer
vaccine, validating an unusual strategy by its maker to introduce the
product even though it failed a late-stage clinical trial.
Shares of Antigenics Inc., the tiny New York-based biotechnology company
which has been developing the vaccine for 11 years, rose as much as 58 per
cent on the news.
A researcher at work in a bio medical laboratory. Russian regulators have
approved the world's first cancer vaccine, validating an unusual strategy
by its maker to introduce the product even though it failed a late-stage
clinical trial.
A researcher at work in a bio medical laboratory. Russian regulators have
approved the world's first cancer vaccine, validating an unusual strategy
by its maker to introduce the product even though it failed a late-stage
clinical trial.
It is the first time the Russian government has approved a drug that was
not first cleared in its country of origin, according to Antigenics, and
clears the way for the company to start generating revenue from Oncophage
later this year.
The company plans to file for approval of the vaccine in Europe by the end
of the year, based on a relatively new set of guidelines in that
jurisdiction.
Regulators in Russia approved Oncophage based on a subset of data from a
late-stage clinical trial that in 2006 failed to show the vaccine delayed
the recurrence of kidney cancer.
In the subset of patients -- those whose cancer was least likely to recur
following surgery -- Oncophage lengthened the period before which the
disease recurred by 45 per cent, or an average of 1.8 years, versus those
in the control group.
The U.S. Food and Drug Administration does not consider subset analysis a
valid measure of success or failure since all manner of sub-populations
can be carved out retrospectively. Therefore, the vaccine stands little
chance of approval in the U.S.
"What this company needs to do now is a trial based on their findings with
the good prognosis patients," said Dr. Otis Brawley, chief medical officer
at the American Cancer Society. "If they have a positive finding at that
point then I'm going to be excited, and then I believe it would go before
the FDA very quickly."
Conducting such trials, however, could take up to 10 years and vast sums
of money, and would take the product's development cycle to 20 years.
"No one in their right mind would authorize that," said Garo Armen, the
company's chief executive, in an interview. "Even if we had the money it
wouldn't be practical."
Unlike their U.S. counterparts, Russian regulators have accepted the
validity of the subset -- in part because roughly a third of the 604
patients enrolled in the late-stage trial were tested in Russia, and about
70 per cent of those fell into the subset of patients whose prognosis
following surgery was better than that of the total population. Antigenics
thinks it will be able to win approval elsewhere in the world too.
European regulators can now approve drugs on a conditional basis, meaning
companies can market their products while simultaneously conducting
additional follow-up of patients. |
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| J |
| Posted: Thu Apr 10, 2008 4:57 am |
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J, no> wrote:
Quote: http://www.canada.com/globaltv/national/health/story.html?id=a4d9928f-91e5-49cc-8755-db92f980c2d2
First cancer vaccine approved in Russia
Toni Clarke, Reuters
BOSTON -- Russian regulators have approved the world's first cancer
vaccine, validating an unusual strategy by its maker to introduce the
product even though it failed a late-stage clinical trial.
Shares of Antigenics Inc., the tiny New York-based biotechnology company
which has been developing the vaccine for 11 years, rose as much as 58 per
cent on the news.
A researcher at work in a bio medical laboratory. Russian regulators have
approved the world's first cancer vaccine, validating an unusual strategy
by its maker to introduce the product even though it failed a late-stage
clinical trial.
A researcher at work in a bio medical laboratory. Russian regulators have
approved the world's first cancer vaccine, validating an unusual strategy
by its maker to introduce the product even though it failed a late-stage
clinical trial.
It is the first time the Russian government has approved a drug that was
not first cleared in its country of origin, according to Antigenics, and
clears the way for the company to start generating revenue from Oncophage
later this year.
The company plans to file for approval of the vaccine in Europe by the end
of the year, based on a relatively new set of guidelines in that
jurisdiction.
Regulators in Russia approved Oncophage based on a subset of data from a
late-stage clinical trial that in 2006 failed to show the vaccine delayed
the recurrence of kidney cancer.
Previous post about oncolphage.
J
View profile
More options Sep 22 2003, 2:24 pm
Newsgroups: sci.med.diseases.cancer
From: J <Fa...@invalid.invalid>
Date: Mon, 22 Sep 2003 14:24:26 -0400
Local: Mon, Sep 22 2003 2:24 pm
Subject: Re: pancreatic cancer vaccine news
Reply to author | Forward | Print | Individual message | Show original | Report this message | Find
messages by this author
Robert Cohen wrote:
Quote: http://www.thisislondon.com/news/articles/6819202?source=Evening Standard
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&...>
BioDrugs. 2002;16(1):72-4.
The low success rate with pancreatic cancers is because of the high
concentration of proteases in that tissue type. []
Called Oncophage (HSPPC-96) if someone wants to look up (maybe) other/more
recent in PubMed or clinical trials.
<http://www.cancer.gov/newscenter/pressreleases/cancervaccines>
Phase III Vaccine Trials |
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