A new malaria fight­ing drug from Glaxo Smith Kline is in it’s final round of test­ing. If every­thing con­tin­ues to go well, the drug could be avail­able to the pub­lic by 2012.

From iAfrica, writer Janine Eras­mus fills us in on the drug’s progress.

GlaxoSmithKline’s (GSK) RTS,S malaria vac­cine has entered phase three of its clin­i­cal trial. This is the crit­i­cal proof-of-concept stage and if it suc­ceeds, the drug could be on the mar­ket by 2012.

Viewed as the most advanced malaria vac­cine avail­able, the RTS,S vac­cine passed its ini­tial tests with fly­ing colours.

The results of the ear­lier stud­ies were pub­lished in the Decem­ber 2008 edi­tion of the New Eng­land Jour­nal of Med­i­cine. Experts sub­se­quently rec­om­mended that stud­ies be advanced to the next stage.

This is sig­nif­i­cant because few vac­cines man­age to meet the rig­or­ous stan­dards of a full clin­i­cal trial, which may take up to 12 years. For any drug to make it this far shows that it is very promis­ing indeed, and RTS,S is the first malaria can­di­date to do so.

Could be ready for 2012

Should phase three tri­als be suc­cess­ful, the man­u­fac­turer is hop­ing to apply for reg­u­la­tory approval in 2011 to begin mar­ket­ing the drug by 2012.

To date, GSK has invested over $300-million (R3-billion) in get­ting RTS,S to this stage since the drug’s ini­tial dis­cov­ery in 1981. The phar­ma­ceu­ti­cal giant received fund­ing for fur­ther devel­op­ment in 2001, from the non-profit PATH Malaria Vac­cine Ini­tia­tive. This ini­tia­tive was born out of a grant to PATH — the Pro­gramme for Appro­pri­ate Tech­nol­ogy in Health — by the Bill & Melinda Gates Foundation.

The Malaria Vac­cine Ini­tia­tive is also striv­ing to ensure that RTS,S is acces­si­ble to those who need it most, and has entered into talks with other organ­i­sa­tions to see how the price can be kept as low as possible.

The organisation’s direc­tor Chris­t­ian Loucq said emphat­i­cally that the cost to African babies and moth­ers would be zero.

GSK has stated that the devel­op­ment of an effec­tive malaria vac­cine, espe­cially for women and chil­dren, is one of its pri­mary goals. The dis­ease kills close on one-million peo­ple every year. Of these, 90 per­cent live in sub-Saharan Africa, and most are chil­dren under the age of five.

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