San Francisco, Calif. July 7, 2003 The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the United States, announced today it has begun Phase III testing of paromomycin to cure one of the world's deadliest parasitic diseases, kala azar, also known as visceral leishmaniasis (VL). Demonstrating a new use for an old medicine, OneWorld Health is developing paromomycin as an affordable and cost-effective life-long cure for VL. Through a $4.2 million grant from the Bill & Melinda Gates Foundation, OneWorld Health is collaborating with the Tropical Disease Research Programme of the World Health Organization (WHO/TDR) in a 670-patient Phase III multicenter clinical trial in Bihar, India.

Following completion of the trial, the goal is to seek regulatory approval of the drug for VL, particularly in India, which has the largest burden for this disease in the world. Paromomycin is an off-patent medicine that was previously approved by the Food and Drug Administration and marketed in the U.S. as a broad-spectrum antibiotic.

Transmitted by the bite of a sand fly, VL is a deadly vector (insect)-borne disease that attacks the internal organs. An estimated 1.5 million people worldwide are currently infected; 200 million people are at risk of acquiring VL; and at least 200,000 people die annually. The disease affects the poorest of the poor, who cannot afford expensive drugs. With the exception of malaria, VL kills more people than any other parasitic disease. While most Westerners have never heard of visceral leishmaniasis, if a disease killed the equivalent number of people in the U.S., it would be the third largest killer after heart disease and cancer, and would cause more deaths than stroke.

"It's not every day one can say an affordable cure for a deadly disease may be imminent, and we believe our approach will be successful," said Dr. Victoria Hale, founder and CEO of OneWorld Health. "This drug appears to be equivalent
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Contact: Sedef Onder
sonder@thehaloproject.com
917-570-8934
Institute for OneWorld Health
8-Jul-2003

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