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| http://www.ynetnews.com/E...1,2506,L-3748014,00.html 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 Medication that can protect humans against nuclear radiation has been developed by Jewish-American scientists in cooperation with a researcher and investors from Israel. The full story behind the dramatic discovery will be published in Yedioth Ahronoth's weekend edition. 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. 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. 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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| Health news A world first: AIDS vaccine cuts the risk of HIV infection by 31 per cent in big Thai study Provided by: Canadian Press Written by: Marilynn Marchione, Michael Casey, THE ASSOCIATED PRESS Sep. 24, 2009 BANGKOK, Thailand - For the first time, an experimental vaccine has prevented infection with the AIDS virus, a watershed event in the deadly epidemic and a surprising result. Recent failures led many scientists to think such a vaccine might never be possible. The World Health Organization and the U.N. agency UNAIDS said the results "instilled new hope" in the field of HIV vaccine research. The vaccine - a combination of two previously unsuccessful vaccines - cut the risk of becoming infected with HIV by more than 31 per cent in the world's largest AIDS vaccine trial of more than 16,000 volunteers in Thailand, researchers announced Thursday in Bangkok. Even though the benefit is modest, "it's the first evidence that we could have a safe and effective preventive vaccine," Col. Jerome Kim told The Associated Press. He helped lead the study for the U.S. Army, which sponsored it with the National Institute of Allergy and Infectious Diseases. The institute's director, Dr. Anthony Fauci, warned that this is "not the end of the road," but said he was surprised and very pleased by the outcome. "It gives me cautious optimism about the possibility of improving this result" and developing a more effective AIDS vaccine, Fauci said. "This is something that we can do." The Thailand Ministry of Public Health conducted the study, which used strains of HIV common in Thailand. Whether such a vaccine would work against other strains in the U.S., Africa or elsewhere in the world is unknown, scientists stressed. Even a marginally helpful vaccine could have a big impact. Every day, 7,500 people worldwide are newly infected with HIV; 2 million died of AIDS in 2007, UNAIDS estimates. "Today marks a historic milestone," said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, an international group that has worked toward developing a vaccine. "It will take time and resources to fully analyze and understand the data, but there is little doubt that this finding will energize and redirect the AIDS vaccine field," he said in a statement. The study tested the two-vaccine combination in a "prime-boost" approach, in which the first one primes the immune system to attack HIV and the second one strengthens the response. They are ALVAC, from Sanofi Pasteur, the vaccine division of French drugmaker Sanofi-Aventis; and AIDSVAX, originally developed by VaxGen Inc. and now held by Global Solutions for Infectious Diseases, a non-profit founded by some former VaxGen employees. ALVAC uses canarypox, a bird virus altered so it can't cause human disease, to ferry synthetic versions of three HIV genes into the body. AIDSVAX contains a genetically engineered version of a protein on HIV's surface. The vaccines are not made from whole virus - dead or alive - and cannot cause HIV. Neither vaccine in the study prevented HIV infection when tested individually in earlier trials, and dozens of scientists had called the new one futile when it began in 2003. "I really didn't have high hopes at all that we would see a positive result," Fauci confessed. The results proved the skeptics wrong. "The combination is stronger than each of the individual members," said the Army's Kim, a physician who manages the Army's HIV vaccine program. The study tested the combo in HIV-negative Thai men and women aged 18 to 30 at average risk of becoming infected. Half received four "priming" doses of ALVAC and two "boost" doses of AIDSVAX over six months. The others received dummy shots. No one knew who got what until the study ended. Thanad Yomha, a 33-year-old electrician from southeastern Thailand, said he didn't expect anything in return for volunteering for the project. "I did this for others," Thanad said. "It's for the next generation." All were given condoms, counselling and treatment for any sexually transmitted infections, and were tested every six months for HIV. Any who became infected were given free treatment with antiviral medicines. Participants were followed for three years after vaccination ended. The results: New infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots. That worked out to a 31 per cent lower risk of infection for the vaccine group. Two of the infected participants who received the placebo died. The vaccine had no effect on levels of HIV in the blood for those who did become infected. That had been another goal of the study - seeing whether the vaccine could limit damage to the immune system and help keep infected people from developing full-blown AIDS. That result is "one of the most important and intriguing findings of this trial," Fauci said. It suggests that the signs scientists have been using to gauge whether a vaccine was actually giving protection may not be valid. "It is conceivable that we haven't even identified yet" what really shows immunity, which is both "important and humbling" after decades of vaccine research, Fauci said. Details of the $105 million study will be given at a vaccine conference in Paris in October. This is the third big vaccine trial since 1983, when HIV was identified as the cause of AIDS. In 2007, Merck&Co. stopped a study of its experimental vaccine after seeing it did not prevent HIV infection. Later analysis suggested the vaccine might even raise the risk of infection in certain men. The vaccine itself did not cause infection. In 2003, AIDSVAX flunked two large trials - the first late-stage tests of any AIDS vaccine at the time. It is unclear whether vaccine makers will seek to license the two-vaccine combo in Thailand. Before the trial began, the U.S. Food and Drug Administration said other studies would be needed before the vaccine could be considered for U.S. licensing. "This is a world first which proves that vaccine development is possible," said Dr. Supachai Rerks-Ngarm, the Thai Health Ministry official who oversaw the trial. "But this is not to the level where we can license or manufacture the vaccine yet." Mass-producing the vaccine, plus how to proceed with future studies, will be discussed among the governments, study sponsors and companies involved in the trial, Kim said. Scientists want to know how long protection will last, whether booster shots will be needed, and whether the vaccine helps prevent infection in gay men and injection drug users, since it was tested mostly in heterosexuals in the Thai trial. The study was done in Thailand because U.S. Army scientists did pivotal research in that country when the AIDS epidemic emerged there, isolating virus strains and providing genetic information on them to vaccine makers. The Thai government also strongly supported the idea of doing the study. - Associated Press Medical Writer Marilynn Marchione reported from Minneapolis. - On the Net: Study information: http://www.hivresearch.org/phase3/factsheet.html Vaccine coalition: http://www.avac.org/ UNAIDS: http://tinyurl.com/krq7kr Government AIDS info: http://www3.niaid.nih.gov/topics/HIVAIDS/ |
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| Experts find 'faulty' gene linked to cancers Tue Oct 6, 6:50 AM LONDON (AFP) - British scientists have identified a faulty gene linked to over half of all breast cancer cases, in what they claim is a major breakthrough in fighting the killer disease. The gene is also linked to half of bowel and prostate cancers and one in four ovarian and bladder cancers, said the experts from Cambridge University's pathology department. The NRG1 gene is found on chromosome 8, one of the packages of DNA inside cells. Cancerous cells are missing the section of chromosome 8 which carries the NRG1 gene, experts have discovered. "I believe NRG1 could be the most important tumour suppresser gene discovery in the last 20 years as it gives us vital information about a new mechanism that causes breast cancer," said Doctor Paul Edwards. "We found the gene on chromosome 8 partly by good luck and partly by good judgment. In every case that we looked at where a big chunk of chromosome 8 had been lost, at least part of the gene was lost. "The gene was effectively 'turned off' in a lot of breast cancers," he added. The gene is present in everyone's DNA, but becomes damaged in some people, allowing cancer to develop. Experts do not yet know exactly why the gene is damaged in some people and not in others. "We have got strong evidence that the gene is implicated in breast cancer but we have no reason to think it's not the same for other cancers, including prostate and colon cancer," said Edwards. "Finding out what genes have been turned off in these cancers is an enormous help in understanding what has gone wrong with their biology." The study was published in the journal Oncogene and funded by Cancer Research UK and Breast Cancer Campaign -- whose head of research Arlene Wilkie also trumpeted the significance of the discovery. "Knowing the identity of this gene will lead to far more detailed studies of how it works and how it is involved in breast cancer development," she said. "This research is a major step forward in understanding the genetics of cancer and could open up a host of new strategies to improve diagnosis and treatment. More than 45,000 women are diagnosed with breast cancer every year in Britain, of whom some 12,000 people die, according to Cancer Research figures. |