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Strong Buy
New human trial for AVI 7537"RAMPING UP" Drugs include AVI 7537, made by Sarepta Therapeutics Inc., which was tested on animals and completed phase 1 human safety studies, but had to be put to the side in late 2011 due to U.S. budget cuts, said Dr. Michael Wong, senior medical director for infectious diseases at Sarepta. "We still have drug substance that is still stable. We are ramping up another human trial," Wong told Reuters. From 60 to 80 percent of rhesus monkeys given AVI 7537 survived, while all of those in the test group died, he said. A phase 1 human safety study under the U.S. Food and Drug Administration found "no safety or tolerance issues at all". "We are looking at ways we can support the WHO if they feel the best way of looking at some agents is through some form of a trial," Wong said. "Because the epidemic is unprecedented and still rolling, they are looking at several different approaches. The theme is to try to do a thorough, careful and ethical job but to do it fast." |
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