AEGiS-WSJ: Scientists, WHO to Announce New Oral Drug for Black Fever

Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

Scientists, WHO to Announce New Oral Drug for Black Fever

Wall Street Journal - June 17, 2002
Gautam Naik, Staff Reporter of The Wall Street Journal

LONDON -- German scientists and the World Health Organization are expected to announce Monday the first oral drug in the battle against "black fever," a debilitating disease that annually infects 500,000 people and kills 60,000.

Black fever, whose medical name is visceral leishmaniasis, is a parasitic disease transmitted through the bite of the tiny sandfly. It is found mainly in India, Brazil and Bangladesh, and one-third of all cases are children between the ages of two and 16. The parasite attacks the liver and spleen, causing fever, weight loss and a blackening of the skin. Those who aren't treated die.

Scientists have long sought better treatments than the existing drugs, which can be given only by injection, making them difficult to administer in poor countries. Many patients suffer nasty side effects. And the parasite has grown increasingly resistant to medicines.

The new oral drug, called miltefosine, was developed by drug maker Zentaris AG, a Frankfurt-based spinoff of German chemical manufacturer Degussa AG. Originally devised as a treatment for breast cancer, miltefosine was accidentally found to be effective against black fever.

Zentaris says it has used the drug in seven clinical studies involving 600 black-fever patients, mainly in India, and has seen cure rates of more than 95%. It also was effective against resistant forms of the black-fever parasite, the company says.

The new drug is part of a special effort by WHO to attack so-called neglected diseases -- those that afflict the world's poorest people. As part of this strategy, WHO is also seeking more effective treatments against malaria and tuberculosis. One of its bigger successes in recent years is the near-eradication of polio.

Miltefosine was developed over six years by Zentaris, with considerable help from the Tropical Diseases Research project, a program sponsored by WHO, the World Bank and the United Nations Development Program. The drug has been licensed in India, home to half of all black-fever cases. The

Indian government says it hopes to eliminate the disease by 2010.

"It's really quite a breakthrough. But as with all new drugs, you have to go very cautiously," says Robert Ridley, coordinator at the WHO program aimed at finding new drugs against black fever.

A growing worry is the spread of black fever among patients infected with HIV, the virus that causes AIDS. The interaction of the two diseases accelerates the onset of AIDS and shortens the life expectancy of HIV-infected people.

Lately, this has even become a problem in countries such as Spain, Italy and France, where the black-fever parasite is found in dogs and sometimes infects people. In Europe, there are about 2,000 cases of HIV-black fever co-infections, according to Zentaris. The company is providing its new drug to about 50 such patients under a "compassionate use" trial.

"Better nutrition in the West protects most of us" against black fever, says Jurgen Engel, chief executive of Zentaris. "But that's not the case if you have an immune system that's compromised."

Miltefosine also triggers side effects, such as vomiting, though they are less severe than those caused by other medicines for black fever. In September, the drug's effects will be further studied during a large clinical trial in India.

Write to Gautam Naik at gautam.naik@wsj.com
020617
WJ020603

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