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[afro-nets] Moxifloxacin - potential new treatment for TB

Moxifloxacin - potential new treatment for TB

If successful, moxifloxacin could be first new treatment for TB
in more than 40 years

19 Oct 2005
Johns Hopkins Medical Institutions

A Johns Hopkins infectious disease expert will lead two interna-
tional studies of the effectiveness of the antibiotic moxiflox-
acin as a new treatment for tuberculosis, the highly contagious
bacterial disease that kills more than 2 million people world-
wide each year and is the leading cause of death of people liv-
ing with HIV and AIDS. Moxifloxacin is currently approved in
more than 100 countries, including the United States, as a
treatment for bacterial respiratory infections, such as bronchi-
tis, sinusitis and pneumonia.

"Defeating the spread of tuberculosis in the United States and
the developing world will require scientists to take bold and
creative new approaches because there has not been a new therapy
for tuberculosis in more than 40 years," says tuberculosis ex-
pert Richard Chaisson, M.D., a professor of medicine, epidemiol-
ogy and international health at The Johns Hopkins University
School of Medicine.

Chaisson will conduct the research as part of a series of stud-
ies on moxifloxacin that are being coordinated by the nonprofit
Global Alliance for TB Drug Development (GATB) in collaboration
with Bayer Healthcare AG, the drug's maker. His research will
assess the ability of moxifloxacin to shorten the treatment pe-
riod required to cure the disease.

One of Chaisson's studies will take place in Brazil, with sup-
port from the U.S. Food and Drug Administration's Office of Or-
phan Product Development. He will co-direct the second study
with Susan Dorman, M.D., an assistant professor at Hopkins, and
John Johnson, M.D., of Case Western Reserve University. The
study will take place in five countries - the United States,
Canada, Brazil, Spain, South Africa and Uganda - with funding
support from the U.S. Centers for Disease Control and Preven-
tion's TB Trials Consortium. (Maryland is one of the 10 U.S.
states where the second study will take place.)

The overall research program, expected to last two to three
years and enroll close to 2,500 patients worldwide, was to be
announced today at a news conference during the 36th annual
World Conference on Lung Health in Paris, France. Other related
studies of moxifloxacin will be led by Stephen Gillespie, M.D.,
of the University College-London, and Andrew Nunn, M.D., of the
British Medical Research Council.

The GATB estimates that 1 billion people worldwide will be in-
fected with tuberculosis by the year 2020, of whom 200 million
will fall ill and 35 million will die. The group is developing
moxifloxacin and other drugs in an effort to cure more patients
by shortening the length of time it takes to treat the disease.

"Shortening the time required to cure the disease could save
millions of lives in the coming years," Chaisson says.

Chaisson has more than two decades of experience researching the
tuberculosis epidemic, especially its impact on the health of
people in developing countries, where most of the 9 million new
cases of the disease occur each year. Current treatments for tu-
berculosis, Chaisson says, consist of a regimen of four antibi-
otic drugs usually, but not always, given in view of a care-
giver. Called Directly Observed Therapy Short-Course, or DOTS,
the drugs must be taken several times daily for six to eight
months. Although DOTS cures 95 percent of those treated, the
lengthy treatment period has proven a problem for patients, who
sometimes miss taking their drugs on time, minimizing the ther-
apy's effectiveness.

Chaisson notes that multidrug-resistant strains of the tubercle
bacillus, formally known as Mycobacterium tuberculosis, are
spreading at a rate of 300,000 newly diagnosed cases each year
that cannot be treated by current drugs. "New options are
needed, and they need to be both effective and easier for pa-
tients to tolerate," he adds.

Chaisson says that substituting moxifloxacin for one of the key
ingredients in DOTS could shorten the treatment period by nearly
two months, to three to four months, making the form far less
costly overall.

As part of the research program, Bayer has agreed to donate sup-
plies of moxifloxacin for all of the trial sites, including
those in Tanzania and Zambia that are part of a third study not
involving Hopkins. The TB Alliance will coordinate the trial and
cover study costs, with additional support from the European and
Developing Countries Clinical Trials Partnership.

In addition to the moxifloxacin study, Chaisson directs the Hop-
kins-based Consortium to Respond Effectively to the AIDS/TB Epi-
demic, called CREATE, an international effort to control the
spread of tuberculosis and treat the disease in countries hit
most hard by the duel epidemics. CREATE, which is sponsored by
the Bill and Melinda Gates Foundation, has three community-based
studies under way in Africa and Brazil.

David March
Tel.: +1-410-955-1534
Johns Hopkins Medical Institutions

Leela McCullough, Ed.D.
Director of Information Services

30 California Street, Watertown, MA 02472, USA
Tel: +1-617-926-9400
Fax: +1-617-926-1212

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