Institute for OneWorld Health Completes Patient Enrollment, Treatment In India for Largest Phase III Clinical Trial for Visceral Leishmaniasis -- Kala Azar --.

Business Editors/Health/Medical Writers

BIOWIRE2K

SAN FRANCISCO--(BUSINESS WIRE)--May 18, 2004

BBC Documentary to Chronicle Challenges of Deadly Disease

The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the U.S., announced today it has completed enrollment and treatment of 667 patients in India suffering from visceral leishmaniasis (VL), a deadly parasitic disease also known as kala azar. Funded largely by the Bill & Melinda Gates Foundation, the largest Phase III clinical trial for VL will conclude with final follow-up patient exams in November. The approval application to use paromomycin will be submitted in early 2005 to the government of India.

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 as many as 200,000 people die annually. Left untreated, it is fatal. With the exception of malaria, VL kills more people than any other parasitic disease. While most Westerners have never heard of visceral leishmaniasis, if the disease existed in the U.S., it would be the third largest killer after heart disease and cancer, and would cause more deaths than stroke.

OneWorld Health is developing the injectable form of paromomycin as a 21-day cure for VL. The drug is an off-patent antibiotic which was previously approved by the U.S. FDA and is still marketed in the U.S. as an oral formulation to treat intestinal parasites. Last June, OneWorld Health initiated the Phase III clinical trial in Bihar, India, in collaboration with the Special Programme for Research and Training in Tropical Diseases of the World Health Organization (WHO/TDR).

"We are very encouraged by initial trial results," said Victoria Hale, Ph.D., CEO of OneWorld Health. "The advantage of finding new uses for existing drugs means people who need affordable medicines the most will benefit sooner, given the wealth of existing safety and efficacy data."

OneWorld Health's leadership in spearheading this clinical trial will be featured beginning Friday, May 21 at 19:30 Greenwich Mean Time (GMT) as part of BBC World's series titled "Kill or Cure - the World's Deadliest Diseases." Using the Indian name for the disease, the BBC's "Kill or Cure" segment on kala azar may be viewed according to the following GMT schedule:

Saturday, May 22 at 10:30

Sunday, May 23 at 20:30

Monday, May 24 at 13:30

Tuesday, May 25 at 16:30

Wednesday, May 26 at 00:30 & 07:30

Further information on viewing times in other regions of the world may be found at http://bbcworld.com/insite/content/template_clickpage.asp?pageid=561 (click on Schedule).

The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the U.S., advances global health by developing new, affordable medicines for infectious diseases that disproportionately affect people in the developing world. OneWorld Health accomplishes this through an entrepreneurial business model in which its staff of experienced pharmaceutical scientists identifies promising drug leads and drives their development from pre-clinical studies to clinical trials through regulatory approval. The Institute for OneWorld Health, headquartered in San Francisco, Calif., is a tax-exempt 501(c) (3), U.S. corporation (www.oneworldhealth.org).