SAN FRANCISCO - Volunteers in Nebraska have begun receiving an experimental tuberculosis drug that developers hope will soon turn the tide against a disease that kills 2 million people annually.
The experimental therapy is the product of a novel development consortium of nonprofit organizations, U.S. government agencies and two drug makers who have come together to beat a disease that disproportionately afflicts the Third World.
Led by the New York-based Global Alliance for TB Drug Development, the group announced Tuesday that it began testing 53 healthy volunteers at a clinic in Lincoln, Neb., to determine if the drug is safe to take. If that's the case, researchers hope to begin a much larger, worldwide human experiment next year.
They aim to have the drug approved for mass distribution within six years, said Dr. Mel Spigelman, head of the alliance's research and development.
Some 2 billion people around the globe are infected with the tuberculosis bacteria, which can lay dormant in its victims for years. It flares up and kills people with compromised immune systems such as the elderly, AIDS patients and others stricken with disease.
The Centers for Disease Control and Prevention reports 14,000 new cases in the United States annually.
Antibiotics can cure tuberculosis, but the treatment can be complicated, arduous and expensive because the current defense against the wily bug involves a regimen of up to four different drugs administered for six months per case.
What's more, many strains of tuberculosis have become resistant to the available drugs.
"It has the promise to be active against these bugs that are resistant," Spigelman said.
The experimental drug, dubbed PA-824, is owned by the biotechnology company Chiron Corp. of Emeryville, Calif. Chiron sold rights to the drug for a "modest fee" to the Global Alliance in 2002 and agreed to allow the nonprofit to distribute it for free in the Third World.
The alliance took over the drug's development and researchers have found that the drug cures TB-infected animals much quicker than the currently available treatments.
"It marks a significant milestone in progress toward our goal of making treatments for TB more effective and shorter in duration," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
Chiron retains the commercial rights to the drug in the developed world.