Immtech International Inc., as part of an international consortium of researchers, is receiving part of the $15.1 million the Bill & Melinda Gates Foundation is providing to develop new drugs to fight African sleeping sickness, or trypanosomiasis, and leishmaniasis.
"We are very pleased and happy to be able to go after trypanosomiasis and pleased that the Bill & Melinda Gates Foundation has funded this," said Gary Parks, chief financial officer at Immtech.
The consortium, formed in 1999, is led by Richard Tidwell, a scientist at the University of North Carolina at Chapel Hill, and involves more than a dozen faculty and scientists from UNC-CH, Georgia State University, the London School of Hygiene and Tropical Medicine, Ohio State University, the Swiss Tropical Institute, the Kenya Trypanosomiasis Research Institute and Immtech.
Immtech, of Vernon Hills, Ill., will receive $4.3 million over the first 18 months and will be responsible for drug development and clinical trials in Africa. Further financial details were not disclosed.
"We will be doing pre-[investigational new drug] and post-IND work, both here and abroad," said James Allen, vice president, regulatory affairs at Immtech. "Our responsibility is the regulatory drug development. We take the compounds into formal drug development."
African sleeping sickness is fatal if left untreated and is spread by the bite of the tsetse fly. Leishmaniasis is caused by a parasite that lives in people, dogs and rodents and is spread through sand fly bites. Leishmaniasis causes lesions, disfigurement and, when the parasite invades internal organs, death.
The drugs available to treat sleeping sickness have drawbacks, Allen said.
"Current therapies are not good," he said. "The main drug used kills about 10 percent of the people they treat. It can be effective, but obviously has some toxicities. Another problem is they must be given intravenously, which is a real issue in developing countries."
Another problem is that drug regimens are extended and trypanosomiasis is showing signs of becoming resistant to drug therapies. Leishmaniasis drugs aren't much better, producing adverse side effects in some patients.
To combat this, Tidwell and his colleagues experimented with DB 289, a compound that allows medication to be orally absorbed and converted to an active state, thus circumventing injection. DB 289 was licensed to Immtech and is in Phase I trials as an anti-infective to treat Pneumocystis carinnii pneumonia. The study is being conducted in Berlin by Parexel International Inc., of Boston, and so far no side effects have been seen.
With the toxicity of current treatments and the problem of administering injections, there is a real need for effective, feasible treatments for the two diseases, Allen said.
"I think the primary reason the Gates Foundation decided to fund this and decided to participate is because of the need," he said. "They saw there could be a drug that could be given orally."