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BOSTON (Reuters)--Russian regulators approved the world's first cancer vaccine, developed by Antigenics Inc., whose CEO is Armenian-American Garo Armenia.
This approval validates 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.
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 percent, 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 United States.
"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 percent 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.
"Filing in Europe won't be a slam dunk, and will probably be more difficult than in Russia," said Armen, who added that the European review process would likely take 12 to 18 months.
The Russian approval caps years of dogged determination to bring the vaccine to the market despite multiple setbacks and investor skepticism of cancer vaccines in general.
Oncophage is designed to reprogram a patient's immune system to target cancer cells from a specific tumor. The company takes tissue from a tumor following surgery, extracts proteins it says activate the immune system and then injects the enriched proteins back into the body through the skin.
Unlike a vaccine such as Merck & Co's Gardasil, which is designed to ward off a virus that is believed to cause some 70 percent of cervical cancer cases, Oncophage is designed to target the cancer directly and delay or prevent it from spreading once it has developed.
Armen founded and chairs the Children of Armenia Fund, which, since its founding in 2000, has focused on revitalizing rural areas by employing a grounds-up approach to address the critical needs of children, as well as to establish economic development activities that enable people to acquire the skills needed to help themselves.
This approval validates 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.
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 percent, 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 United States.
"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 percent 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.
"Filing in Europe won't be a slam dunk, and will probably be more difficult than in Russia," said Armen, who added that the European review process would likely take 12 to 18 months.
The Russian approval caps years of dogged determination to bring the vaccine to the market despite multiple setbacks and investor skepticism of cancer vaccines in general.
Oncophage is designed to reprogram a patient's immune system to target cancer cells from a specific tumor. The company takes tissue from a tumor following surgery, extracts proteins it says activate the immune system and then injects the enriched proteins back into the body through the skin.
Unlike a vaccine such as Merck & Co's Gardasil, which is designed to ward off a virus that is believed to cause some 70 percent of cervical cancer cases, Oncophage is designed to target the cancer directly and delay or prevent it from spreading once it has developed.
Armen founded and chairs the Children of Armenia Fund, which, since its founding in 2000, has focused on revitalizing rural areas by employing a grounds-up approach to address the critical needs of children, as well as to establish economic development activities that enable people to acquire the skills needed to help themselves.
