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Go-ahead for anti-AIDS gel trials
By CNN's Grant Holloway
SYDNEY, Australia (CNN) -- An Australian company has won regulatory approval to begin human trials for an anti-AIDS gel which could dramatically reduce the spread of the virus in developing countries. Melbourne-based Starpharma announced Thursday that the U.S. Food and Drug Administration (FDA) has given clearance for phase one human trials of the trial the gel. The drug has proved 100 percent effective in preventing HIV and other sexually-transmitted diseases in primate trials. The gel -- if human trials prove successful -- would be particularly targeted at women in poorer nations, giving them cheaper, easier personal control over HIV prevention. "This is a major achievement for Starpharma as there have been very few locally developed new chemical entity drugs that have undergone phase one trials in Australia under the rigorous requirements of the US regulatory system," Starpharma CEO Dr John Raff said in a statement. A report by the Rockefeller Foundation into HIV prevention, released earlier this year, estimates up to 2.5 million lives could be saved over three years if such a product was readily available. In animals trials using macaque monkeys, a single application of the VivaGel product proved 100 percent effective against the monkey version of HIV as well as animal versions of genital herpes and chlamydia. The human trials of the product are now planned to begin in Australia by the end of this year. These will then be followed by a second 12-month trial involving at least 8,000 women with a possible prescription-only product available in three years' time. It would be another two years after that before an over-the-counter type product could be distributed. Raff told CNN VivaGel was a "first of its type" product which could set a precedent for the development of other disease treatments in years to come. Microbicides are gels, films, sponges or other products applied directly to the skin to help prevent the spread of disease. They are particularly useful for women in poorer countries as they give them more control in helping prevent disease, particularly in cultures where condoms are a male-dominated product. Women are also more vulnerable to contracting HIV from a single sexual encounter. Countries such as Myanmar and Papua New Guinea face looming AIDS crises of a scale similar to those seen in Africa because of a lack of preventative measures. A recent Australian government aid report says the working population of PNG could be cut by 38 percent by 2020 if infection rates follow those seen in Zimbabwe. In Myanmar it is estimated that as many as 1 in 50 people has HIV with the disease spreading rapidly among the general population from high-risk groups such as prostitutes and intravenous drug users. At the end of last year, 42 million people worldwide were infected with the virus that causes AIDS and by 2010 it is estimated a further 45 million people will be infected.
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