VERNON HILLS, Ill. -- Immtech International, Inc. announces that it has successfully enrolled malaria-afflicted patients in a Phase IIa human clinical trial with Immtech's oral drug DB289. The clinical trial is designed to test the safety and efficacy of DB289 against both the Plasmodium vivax and Plasmodium falciparium strains of malaria, the two most common and deadly forms of malaria. Enrollment is completed for patients infected with Plasmodium vivax, and patients infected with Plasmodium falciparium are being enrolled.
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. The trial is being conducted at a hospital clinic in Thailand that is experienced in evaluating new malaria drugs. The United States Food and Drug Administration 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. Once all patients in both arms of the study have completed dosing, results on the safety and efficacy of DB289 will be made available after the data is collected and analyzed.
Malaria is a significant health threat for 2 billion people in the world who are exposed to this infection caused by a parasite transmitted by mosquitoes. Existing treatments on the market are not very effective against drug resistant strains and can cause severe side effects. Malaria, which affects 350 to 400 million people each year, is especially devastating to children under the age of 5. The World Health Organization (WHO) estimated that more than 1 million children die every year from malaria. Every 40 seconds a child dies from malaria.
Stephen Thompson, Immtech president and CEO said, "We are pleased with the pace at which the trial is progressing. Malaria is a deadly and devastating infectious disease. We are committed to bringing an effective oral anti-malarial drug to market."
Immtech International, Inc. is a pharmaceutical company focused on the commercialization of oral treatments for infectious diseases such as pneumonia, fungal infections, malaria, tuberculosis, diabetes, hepatitis and tropical diseases such as African sleeping sickness and Leishmania.
Source: Immtech International, Inc.