VERNON HILLS, Ill. -- Immtech International, Inc. announced today that it has completed the initial pilot stage of the Phase IIa human clinical trial of its first oral drug candidate DB289 to treat malaria patients in Thailand.
The trial results demonstrated that DB289 was safe to administer and was efficacious in the patients tested. Data showed that on average the malaria parasite was eliminated from the blood in approximately 95 percent of the patients in less than three days, and those patients tested remained completely parasite free 28 days after treatment. The initial study focused on evaluating the safety of DB289 in an Asian population infected with Plasmodium vivax (P. vivax) malaria. P. vivax is a form of malaria that accounts for approximately half of the 300-400 million new cases each year. P. vivax is clinically less severe than Plasmodium falciparum (P. falciparum), a life-threatening form of malaria, but P. vivax results in a high percentage of patients who develop a chronic form of the disease. P. vivax has approximately a 90 percent chance of reoccurring in patients who are treated with current drugs because the parasites could not be completely eliminated, and current drugs have not been effective when the disease reaches the liver stage.
In addition to the safety and efficacy results, the trial also indicated that the fever associated with malaria was on average eliminated within 16 hours for the same group of patients. All the patients tolerated DB289 without any adverse effect. Immtech plans to reevaluate these Phase IIa patients again in 60 days to test for any reoccurrence of the disease and any trace of parasite. A second stage of the clinical trial to treat malaria patients infected with P. falciparum, the most deadly and drug resistant form of malaria, has commenced and patient enrollment is on schedule. Immtech plans to release a summary of the P. vivax and P. falciparum clinical trial results at the end of the study. This 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 (FDA) approved the export of DB289 for use in the trial, and Thailand's National Institute Review Board, a governmental organization with oversight authority of all new drug studies, approved the DB289 clinical trial protocols.
Malaria is a significant health threat afflicting 2 billion people worldwide. DB289 is being tested in the two most common and deadly strains of malaria, P. vivax and P. falciparum. Existing malaria treatments are often not effective due to the drug resistance of the parasite that causes malaria, and these treatments can cause severe side effects. Malaria, which affects 300 to 400 million people each year, is especially threatening to children under the age of 5. The World Health Organization estimates that 1 million children die from malaria every year, equivalent of one child dying every 30 seconds.