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VERNON HILLS, Ill. -- Immtech International, Inc. announces that the company's oral drug candidate, DB289, demonstrated potent anti-malarial activity in the human clinical trial conducted in Bangkok, Thailand. The results were presented at the Annual Meeting of the American Society of Tropical Medicine and Hygiene on Dec. 6, 2003 in Philadelphia.
Steven Meshnick, MD, PhD, professor of epidemiology and microbiology at University of North Carolina at Chapel Hill, who was the co-investigator for the trial, stated, "DB289 showed exceptional results in this initial clinical trial as a treatment for malaria. The cure rate of the patients infected with malaria was much higher than expected for a monotherapy drug such as DB289. The next clinical trial phase will focus on optimizing the dose regimen, as well as evaluating the activity of DB289 in combination with other drugs."
In addition to the malaria trial, DB289 is also being successfully tested in human clinical trials targeting Pneumocystis carinii pneumonia (PCP), a fungus that causes severe lung infections in immunosuppressed patients, and Africa sleeping sickness, a parasitic disease affecting 60 million people in the sub-Sahara region. DB289's effectiveness in treating three different diseases demonstrates the broad application of the dication technology platform.
T. Stephen Thompson, president and CEO, said, "We are encouraged by the results of this trial and the international health community's commitment to rapidly moving the drug forward. DB289 has the potential to successfully address the malaria market, estimated to be $750 million to $1 billion. Malaria affects billions of people in the world and kills two million annually. A more effective treatment is urgently needed to address the death and illness being caused by malaria, as international travels increase dramatically. Immtech works closely with its Consortium members to demonstrate that increasing shareholder value and curing socially and economically devastating diseases are not mutually exclusive. We are energized by the successes of the trial, which strengthen our resolve to develop new oral drugs to treat many of the world's most deadly diseases."
The patients who participated in the malaria trial were treated with 100 mg capsules of DB289, twice per day for five consecutive days. All 32 treated patients cleared the malaria parasite and malaria symptoms (i.e. fever) disappeared quickly within the five-day treatment period; 50 percent of the patients cleared the malaria parasite within 24 hours of the first dose. Tolerance to DB289 was excellent with no significant adverse side effects reported. All patients were followed and monitored for 28 days after treatment to ensure that the malaria parasite had been completely eliminated, since reoccurrence rate is very high with the commonly used malarial treatments.
Out of the 32 patients, nine were infected with Plasmodium vivax and 23 patients with Plasmodium falciparum, the most deadly form of malaria found in humans. P. vivax infected patients usually have less severe symptoms, but reoccurrence is very high and a large percentage develop a chronic liver form of the disease. P. falciparum has more severe symptoms (including high fever), and it causes over 2 million deaths per year. Commonly used drugs have high levels of drug-resistance.
The P. falciparum patients were treated with DB289 as a monotherapy (not in combination with any other drugs -- generally combination therapy is used). Of the 23 patients treated for P. falciparum, the cure rate was 91 percent as two of the patients had malaria in the 28-day after treatment period. However, blood samples from both patients are being analyzed to determine if a new infection had occurred after the treatment. Nine P. vivax patients were treated with DB289 for five days followed by oral Primaquine, since drug combination therapy is used as standard therapy. 100 percent of patients treated with both drugs remained clear of any parasites on the 28th day of the trial, without any adverse events or safety issues with the combination therapy.
Malaria is transmitted by mosquitoes to humans. The infectious disease is found in areas of the world populated by 2 billion people (1/3 of the world's population). The disease affects about 300,000 - 500,000 people each year globally, and it is a significant problem in small children. It is estimated by the WHO that one child dies every 30 seconds from malaria. The WHO and other international organizations have called for the development of new drugs to treat the multi-drug resistant cases of malaria.
Source: Immtech International, Inc.