Exclusive: Dramatic discovery by Jewish-American scientists could change world; anti-radiation medication proves effective, safe in tests. Further experiments to be fast tracked, FDA approval possible within 1-2 years
Ronen Bergman
The ground-breaking medication, developed by Professor Andrei Gudkov – Chief Scientific Officer at Cleveland BioLabs - may have far-reaching implications on the balance of power in the world, as states capable of providing their citizens with protection against radiation will enjoy a significant strategic advantage vis-à-vis their rivals.
For Israel, the discovery marks a particularly dramatic development that could deeply affect the main issue on the defense establishment's agenda: Protection against a nuclear attack by Iran or against "dirty bomb" attacks by terror groups.
Gudkov's discovery may also have immense implications for cancer patients by enabling doctors to better protect patients against radiation. Should the new medication enable cancer patients to be treated with more powerful radiation, our ability to fight the disease could greatly improve.
Dramatic test results
The process that led up to the medical innovation dates back to 2003, when Professor Gudkov came up with the idea of using protein produced in bacteria found in the intestine to protect cells from radiation.
Gudkov recounted an experiment he held with two groups of mice.
"We exposed both groups to lethal radioactive radiation," he said. "All the mice in the control group died within a short period of time. A few days later, when I approached the cage with the mice that received the protein, I could see that they're ok, that they're alive. They survived. It's hard to describe the joy all of us felt. We realized that finally, after so many years and so many experiments and frustrations, we made a breakthrough that may save the lives of millions."
Prof. Gudkov published the findings of the protein experiment in Science, the world's leading scientific journal; however, the discovery of the medication was kept secret until now, while Gudkov and his associated waited for the results of two series of critical tests examining the medication's effectiveness and safety.
The first series of tests included experiments on more than 650 monkeys. Each test featured two groups of monkeys exposed to radiation, but only one group was given the medication. The radiation dosage was equal to the highest dosage sustained by humans as result of the Chernobyl mishap.
The experiment's results were dramatic: 70% of the monkeys that did not receive the cure died, while the ones that survived suffered from the various maladies associated with lethal nuclear radiation. However, the group that did receive the anti-radiation shot saw almost all monkeys survive, most of them without any side-effects. The tests showed that injecting the medication between 24 hours before the exposure to 72 hours following the exposure achieves similar results.
Another test on humans, who were given the drug without being exposed to radiation, showed that the medication does not have side-effects and is safe. Prof. Gudkov's company now needs to expand the safety tests, a process expected to be completed by mid-2010 via a shortened test track approved for bio-defense drugs. Should experiments continue at the current rate, the medication is estimated to be approved for use by the FDA within a year or two.
'Stable, safe, and easy to inject'
The company's subcontractor in Europe is already prepared to embark on mass production. Meanwhile, emergency regulations in Israel allow the government to purchase drugs on short notice, even if they are still in the process of being approved. Notably, the medication in question is not a vaccine, but rather, a preventative drug administered via one or several shots.
The medication works by suppressing the "suicide mechanism" of cells hit by radiation, while enabling them to recover from the radiation-induced damages that prompted them to activate the suicide mechanism in the first place.
Prof. Gudkov heads a group of Jewish-American scientists and has cooperated with an Israeli researcher and Israeli investors. A large part of the revolutionary medication's development process was funded by the US Defense and Health departments, which thus far earmarked $40 million to the project. About two weeks ago, the US Defense Department announced that in light of the successful tests, it will continue to fund the project.
The Israeli scientist involved in the research, Dr. Elena Feinstein, made Aliyah to Israel in 1985 and for many years served as a cancer researcher at the Weizmann Institute of Science. Dr. Feinstein met Prof. Gudkov while they worked together in Moscow and was among the founders of the company, serving as its deputy director for some time.
Today, Feinstein works for an Israel company engaged in cancer research and continues to cooperate with Gudkov. Referring to the innovative medication, she says: "Both its effectiveness and safety had been proven. It is stable, safe, and easy to inject."
Both Feinstein and Gudkov stress that the innovative drug does not provide 100% protection against radioactive damage. However, should the discovery announced by the scientists meet all the required tests and permits, it may change the 21st Century.
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