Antigenics has announced the launch of phase-III trial for malaria vaccine, RTS,S by GlaxoSmithKline, which contains Antigenics’ QS-21 Stimulon adjuvant.
Phase-II malaria studies showed that, over an eight-month follow-up period, RTS,S reduced clinical episodes of malaria by 53%. Also, it had a promising safety and tolerability profile when used alongside standard infant vaccines.
The phase-III trial builds on more than 10 years of clinical research in Africa, including the first proof-of-concept study in children in 2004, and a proof-of-concept study in infants in 2007.
The company plans to submit initial regulatory review in 2011, upon receiving clinical results. If the required regulatory clearances are granted and international and African national public health authorities recommends, RTS,S could be introduced in 2012.
Garo Armen, Chairman and CEO of Antigenics, said: “There are now approximately 15 vaccines containing QS-21 in clinical trials of which four have now progressed into Phase 3 studies across multiple indications including non-small cell lung cancer, melanoma and malaria.”
“Today’s announcement demonstrates that QS-21 is a critical adjuvant in the development of therapeutic and prophylactic vaccines,” he added.