During a press briefing earlier today at MIM, pharmaceutical company GlaxoSmithKline and its partners, the PATH Malaria Vaccine Initiative (MVI) and the Bill & Melinda Gates Foundation, announced that Phase III trials of RTS,S, the world’s most advanced malaria vaccine candidate, are currently underway in seven African countries. Thus far, more than 5,000 children have already been enrolled in this trial, which will eventually enroll 16,000 children.
Phase II studies published in the Lancet in 2004 and 2005 demonstrated that the vaccine is capable of reducing clinical episodes of malaria by 35 percent and severe malaria by 49 percent.
The current Phase III trial will evaluate the vaccine’s ability to prevent malaria in two age groups: infants aged 6 to 12 weeks and children aged 5 to 17 months. If these trials are successful, data based on efficacy in children 5-17 months of age could be submitted under the European Medicines Agency (EMEA) Article 58 – a regulatory framework for pharmaceutical product intended exclusively for export – as early as 2012.
Thus far, GSK has invested $300 million in this project and expects to invest an additional $100 million before its completion. The Bill & Melinda Gates Foundation has also provide the project with more than $200 million of financial support.
For more information, please read GSK and MVI’s joint press release:
http://www.eurekalert.org/pub_releases/2009-11/bc-wlm110209.php
