Breakthrough Tuberculosis Treatment now tested on humans
Published: June 14, 2005
A group of foundations, nonprofits and companies, including RTI International in Research Triangle Park, has started testing in humans one of the first new breakthrough treatments for tuberculosis in about 40 years.
RTI, a research institution that contracts with the federal government, has about 10 employees working on the effort and is overseeing the clinical development of the drug called PA-824. Development of PA-824 is spearheaded by the Global Alliance for TB Drug Development, a consortium that also includes the Bill and Melinda Gates Foundation, the Rockefeller Foundation and the U.S. Agency for International Development.
Despite an increasing need for better tuberculosis treatments, especially in sub-Saharan Africa and Southeast Asia, large pharmaceutical companies have done little to look for new drugs to treat the deadly disease, which can destroys lungs and ravage bodies.
Countries unable to afford expensive new drugs make poor customers.
To develop PA-824 and make the experimental drug affordable for those countries, the consortium is acting like a pharmaceutical company.
PA-824 won’t become available for at least five years. But the start of human tests “demonstrate the feasibility of this model,” said Doris Rouse, director of RTI’s global health center. In the end, the drug development process could be as significant as the drug, showing that a collaboration of public and private groups can overcome the challenges of developing and providing affordable medicines to poor countries.
“[The model] works. It works in a timely way,” said Rouse.
About 10 percent of those who are infected develop an active case of the disease, according to the World Health Organization.
The four existing treatments require patients to take a drug cocktail of up to 22 pills in a day for about six months. PA-824 promises to replace one or two of the four drugs and shorten the treatment period to no more than two months.
That would significantly lower the cost of public health programs that make sure patients take their drugs properly, said Mel Spigelman, the TB Alliance’s director of research and development.
Costs for the current treatments vary widely, from as little as $15 to as much as $1,500. It’s too early to say how much PA-824 will cost, Spigelman said.
But the TB Alliance doesn’t have to recoup its investment like a traditional pharmaceutical company, he said. “If [PA-824] makes it, money and the cost of the drug will not stand in the way to get it to the people who need it.”
PA-824 was discovered in 1995 at PathoGenesis, a company that was acquired in 2000 by California-based Chiron. Chiron shelved the experimental drug.
“For a compound of this nature, commercial considerations play a role,” said John Gallagher, Chiron’s spokesman. “It didn’t make a lot of sense to move forward.”
Chiron agreed to license PA-824 to the TB Alliance, asking only for an option to market the drug in the United States and Europe should clinical tests show PA-824 works well and is safe.
For good reason.
The number of TB cases in the United States has dropped from 84,000 in 1953 to 14,900 in 2003, according to the Centers for Disease Control in Atlanta. But about half of all new cases in the U.S. are immigrants from countries where TB is virulent.
Rouse has written in the past that TB “is just a plane ride away.”
RTI became involved in the search for a new affordable TB drug in 1999 when it was awarded a seven-year contract worth $5.9 million from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. Rouse and a team of researchers were charged with accelerating the commercial availability of TB treatments developed in university, government and industry labs and worked with 26 institutions in nine countries.
On Friday, RTI sent Karl Whitney to Lincoln, Neb., where MDS Pharma Services is testing the drug in healthy volunteers, to observe the beginning of the human tests. The biomedical researcher and regulatory expert watched as a pharmacist counted down the seconds before the first volunteer, a man in his early 20s, lifted a small cup to his lips and dropped the pill in his mouth.
About two hours later, he e-mailed Rouse his first report: “All is going well.”
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