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 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.
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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 Japan's Otsuka.
(Reporting by Julie Steenhuysen; editing by Jan Paschal)
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