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VERNON HILLS, Ill.-- Immtech International, Inc. has initiated patient enrollment of an expanded Phase IIa clinical trial of its oral drug candidate DB289 for the treatment of malaria. The clinical trial is designed to test the safety and efficacy of DB289 against both the Plasmodium vivaxx and Plasmodium falciparium strains of malaria, the two most common and deadly forms of the disease.
Each patient will be dosed twice a day for five days and will remain at the trial site for an additional 23 days to ensure that the malaria parasite is cleared from the blood stream. The trial is being conducted at a hospital clinic in Thailand that is experienced in evaluating new malaria drugs. The Food and Drug Administration (FDA) approved the export of DB289 to Thailand for use in the trial, and Thailand's National Institutional Review Board, a governmental organization with oversight authority of all new drug studies, approved the open label (all patients will receive DB289) clinical trial protocol.
Malaria is a significant problem for more than 2 billion people in the world that are exposed to the parasitic disease caused by a parasite that is transmitted by mosquitoes. The disease, which affects 350 to 400 million people each year, is especially devastating to children under the age of 5. It is estimated by the World Health Organization (WHO) that in Africa, where the disease is endemic, over 1 million children die every year from malaria; one child dies every 30 seconds from the disease. Existing treatments on the market are not very effective against drug resistant strains, and can cause severe side effects. Stephen Thompson, president and CEO said, "We are excited about the promise of DB289 to help in the battle against Malaria. Malaria has a significant impact on the health and the economies of developing countries in all areas of the world. There is clearly a need for a new oral drug that is safe and can be used to treat patients with drug-resistant disease".
Malaria is spread by infected mosquitoes that bite and transmit the parasites to humans. Once inside the body, the parasite travels to the liver and invades the red blood cells. Symptoms associated with the disease include fever, headaches, chills, and vomiting. If left untreated, the parasite can attack the blood vessels in the brain and can cause convulsions, coma and death. Malaria can also lead to kidney and respiratory failure.
Source: Immtech International, Inc.