Intravenous Artesunate: The New Generation of Lifesaving Treatment for Severe Malaria in the Warfighter; Conference paper

摘要

Artemisinins are antimalarials derived from the Chinese herb, Artemisia annua. These compounds clear the parasites from the blood more rapidly than other antimalarial agents. Intravenous formulations of artemisinins have been used in much of the world and represent an improvement in efficacy and safety for severe malaria. There are currently no FDA-approved intravenous artemisinin products available in the U.S. The Walter Reed Army Institute of Research has a long history with the artemisinins which has culminated in an intravenous artemisinin product. Between 2000 and 2002, two derivatives were in consideration (artesunate and artelinate) for development to licensure. After intense scrutiny and eventual consideration in committee at the Division of Experimental Therapeutics, artesunate was selected as the compound to put forward into advanced development. Artesunate is currently in use in much of the malarial world as a non- International Conference on Harmonisation (ICH) current Good Manufacturing Practices (cGMP) intravenous formulation produced in China and therefore gives us a potential wealth of clinical data. We envision our formulation of an ICH compliant, cGMP-produced, and FDA-licensed intravenous artesunate being available for use in the very near future for US military and civilians as well as eventual use worldwide. We have successfully filed an Investigational New Drug Application for this product and clinical trials with this agent are well underway. Our presentation will update the progress that has been made in preclinical studies, data from early current Good Clinical Practices (cGCP) Phase 1 trials (the first regulated Phase 1 work ever done with artesunate), data from early cGCP Phase 2 trials in Kenya, future planned clinical work, and our overall strategy for gaining full licensure of this product in the United States by the end of 2007.