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www.fdanews.com/articles/90677-immtech-begins-phase-ii-study-of-malaria-prophylaxis

IMMTECH BEGINS PHASE II STUDY OF MALARIA PROPHYLAXIS

December 13, 2006

Immtech Pharmaceuticals has initiated a Phase II trial in the U.S. of its oral drug candidate, pafuramidine maleate, as a prophylaxis to prevent malaria infections for travelers to endemic regions. This study protocol was reviewed by the FDA and has been approved by the institutional review board of a major U.S. medial center.

It is estimated that each year 125 million travelers go to countries where malaria is endemic. Malaria is found in such Asian countries as India, Indonesia, Thailand, Philippines and Singapore; several Middle Eastern countries including Saudi Arabia, Turkey, Pakistan, Iraq and Afghanistan; most of Africa; and in Brazil, Venezuela, Peru, Columbia and southern Mexico.

The company expects pafuramidine to be highly effective both as a prophylaxis and as a treatment against Plasmodium falciparum, the most serious species of malaria. The drug has not been associated with the significant neurological, gastrointestinal or photosensitivity-related side effects or psychotic episodes that are often reported by travelers who use currently approved malaria prevention medications, according to the company.

Volunteer participants will be enrolled the randomized, double-blind challenge study of malaria infection that will take place in a specialized clinical trial unit. The primary purpose of the study is to determine whether pafuramidine can prevent the initial infection of the liver and also prevent development of symptoms caused by malaria parasites infecting red blood cells. Each volunteer will be given either pafuramidine or a placebo and then exposed to malaria parasites that are sensitive to treatment with chloroquine. All subjects will be carefully monitored for malaria and promptly treated if they become infected.