GSK begins phase III global trial for malaria vax

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GlaxoSmithKline is pushing forward with the final stages of pre-approval development of its malaria vaccine candidate Mosquirix. Scientists began injecting 1,200 infants and children involved in its Phase III trial with the experimental jab last week. The study kicked off in Bagamoyo, Tanzania, located on the East African coast. It will eventually include 16,000 patients in seven African countries--the largest-ever trial of a malaria vaccine candidate.

The product of a partnership between GSK and PATH Malaria Foundation, planning for the global clinical trial began last November. Mosquirix is the first malaria vaccine candidate to reach a late-stage trial. It took GSK 17 years to get to this point, but the jab may be available in the next few years. It could come to market from 2011 to 2013. The outlook for the global trial is promising since it has performed well in smaller tests. In a study in Tanzania, the vaccine reduced the risk of malaria infection over a six-month period by up to 65 percent in babies under a year old. In another trial involving Kenyan and Tanzanian toddlers between five and seventeen months old the vax reduced cases of malaria infection requiring hospitalization by 53 percent.

The Times reports that Mosquirix is designed for people at high risk of contracting the disease and it will not be available to tourists as an alternative to malaria pills. Donor groups will likely purchase the vaccine for developing countries and GSK will make sure cost is not an issue, Jean Stephenne, Head of GSK's vaccine unit, tells the Wall Street Journal. "The last thing we expect to do is make a profit in endemic malarial areas," a GSK spokeswoman told the Journal. But the spokeswoman says GSK will seek to cover its cost of production. According to The Times, the drugmaker has invested $300 million so far. Development has been backed by the Bill and Melinda Gates Foundation, which put up $107.6 million over 10 years.

- get more from The Times
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here's the WSJ report

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