Gates-backed TB drug to enter late-stage testing
By Julie Steenhuysen
CHICAGO, April 23 (Reuters) - The first experimental drug that fights both conventional and drug-resistant forms of tuberculosis is advancing to late-stage clinical testing, researchers said on Wednesday, raising hope for a new way to stem the growing threat of drug-resistant TB.
The trial, financed in part by the Bill & Melinda Gates Foundation, will test the safety and effectiveness of a new three-drug cocktail known as PaMZ that in mid-stage testing helped to significantly reduce treatment times.
In a statement announcing the trial, Microsoft co-founder Bill Gates, co-chair of the Gates Foundation, said the treatment could "reduce the time required to cure drug-resistant TB from two years to just six months" and sharply cut the cost of a cure in low-income countries. He called on other funding groups to back the trial, which is estimated to cost $58 million.
The World Health Organization estimates that 8.6 million people developed TB in 2012 and 1.3 million died from the disease. According to the WHO, half a million people became sick with dangerous superbug strains of tuberculosis in 2012, and as many as 2 million people worldwide may be infected with drug-resistant TB by 2015.
The trial, set to begin in November, will span some 50 study sites across Africa, Asia, Eastern Europe and Latin America.
If successful, the oral treatment would eliminate the need for injectable drugs and reduce the cost of multiple-drug-resistant TB therapy in some countries by more than 90 percent in those patients whose TB is sensitive to the three drugs.
The therapy also promises to be compatible with commonly used treatments for human immunodeficiency virus or HIV, helping the millions of people infected with both TB and HIV, the virus that causes AIDS.
Jan Gheuens, who manages the TB drug program for the Gates Foundation, said the study's results could be ready by 2017, and if the findings are positive, approval could be expected by the end of 2018. Continuación...