| CHICAGO, April 23
CHICAGO, April 23 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
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.
Dr. Mel Spigelman, chief executive officer of the TB
Alliance, a non-profit research group that will conduct the
study, said the treatment will only be effective in about a
third of patients with multiple-drug resistant TB or MDR-TB.
But even at that rate, he said the therapy could help
"revolutionize" treatment because currently, only about 15
percent of patients with MDR-TB get treatment, and only half of
those are cured.
Standard treatment for TB usually includes a mix of four
drugs over a period of six months. MDR-TB can take 18 to 24
months to treat.
The trial announcement followed the successful approval of
Johnson & Johnson's drug, bedaquiline, in 2012 for the
treatment of drug-resistant TB. This was the first new TB drug
in more than 40 years. Last fall, the European Medicines
Agency's Committee for Medicinal Products for Human Use
recommended granting conditional marketing approval for
delamanid, a treatment for drug-resistant TB being developed by
(Reporting by Julie Steenhuysen; Editing by Jan Paschal)