E-drug: New TB Therapy May Halve Treatment Time
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The Global Alliance for TB Drug Development (TB Alliance) and Bayer
Healthcare AG today announced a partnership to coordinate a global
clinical trial program to study the potential of an existing antibiotic,
moxifloxacin, to shorten the standard 6-month treatment of tuberculosis
(TB) by two-three months.
If the trials are successful, the partnership aims to register
moxifloxacin for a TB indication and is committed to making it
affordable and accessible in developing countries where patients need it
most. The trials will take place in Brazil, Canada, South Africa, Spain,
Tanzania, Uganda, the United States and Zambia.
For full press release in English, French, German, Chinese, Spanish,
Portuguese and Japanese & additional information and press coverage,
please visit: http://www.tballiance.org/bayer.asp. Story from
Associated Press Below (copied as fair use).
Any questions, please let me know.
Gwynne Oosterbaan
Assistant Director, Public Affairs & Advocacy
TB Alliance - The Global Alliance for TB Drug Development
Gwynne.oosterbaan@tballiance.org
212-227-7540 ext 209
646-258-8410 (cell)
www.tballiance.org <http://www.tballiance.org>
AP Story below & photos of TB patients in Durban South Africa on
http://news.search.yahoo.com/news/search?ei=UTF-8&p=tb+alliance&c=news_p
hotos
[Pls repair link]
Associated Press
New TB Therapy May Halve Treatment Time
By TERRY LEONARD; Associated Press Writer
JOHANNESBURG, South Africa - A new therapy for treating tuberculosis
could cut the current six-month treatment time in half, expand the
number of patients and save millions of lives, a nonprofit that seeks
treatments for the disease said Monday.
The Global Alliance for TB Drug Development and Bayer HealthCare AG said
they would coordinate clinical trials of the combination therapy for
about 2,500 patients in South Africa, Uganda, Brazil, the United States,
Canada, Spain, Tanzania and Zambia. Some trials already have been
conducted or are under way in South Africa and Uganda.
The initiative addresses the leading cause of death for people infected
with HIV, the virus that causes AIDS, and is an example of the new
public-private partnerships that are focusing attention on so-called
"neglected diseases" in the developing world.
Dr. Maria C. Freire, president and chief executive officer of the
Alliance, said the new treatment, which could be approved in five years,
has the potential to reduce the six months of treatment for tuberculosis
by two to three months, lower the risks of developing resistant strains
and expand the number of patients receiving treatment.
"Our model of what shorter therapy means is that it literally will save
millions of lives," Dr. Mel Spigelman, the head of research and
development for the Alliance, said in a telephone interview.
Currently about 9 million new active cases of the disease develop each
year and about 2 million people die. According to current projections,
200 million more people will fall ill with TB by 2020 and 35 million
will die.
In Africa and other places in the developing world where medical
infrastructure can be primitive, Freire said shortening treatment time
will improve adherence and reduce the number of infections from
resistant strains. Resistant strains develop when patients do not adhere
to the arduous six-month treatment until they are cured.
The trials will test the effectiveness of using the antibiotic
moxifloxacin in combination with existing tuberculosis drugs.
Moxifloxacin has already been approved in 104 countries for treatment of
bacterial respiratory and skin infections. The tests seek to have it
registered as a treatment for tuberculosis.
The HIV pandemic is responsible for much of the explosion in the number
of new tuberculosis cases each year and is the reason the World Health
Organization now says the Millennium Development Goal of reversing the
growth in TB by 2015 will not be achieved. There are an estimated 12
million people infected with both HIV and TB.
Dr. Wolfgang Plischke, head of the pharmaceuticals division at Bayer
HealthCare, said some of the drugs currently used to treat tuberculosis
react adversely with HIV treatments.
"Moxifloxacin doesn't have that problem," said Plischke, who added that
the antibiotic has been used successfully to treat other infections in
people taking anti-retrovirals for HIV.
Plischke said about 2 billion people worldwide are infected with the
tuberculosis bacteria, which can lay dormant in its victims for years.
About a third of those infected develop active cases. It flares up and
kills people with compromised immune systems such as the elderly, AIDS
patients and others stricken with disease.
"That number is mushrooming," said Plischke.
Freire said if the new therapy successfully cuts the treatment time by
two to three months as studies indicate, the goal of reversing the
growth in TB infections by 2015 will be met.
In the trials, moxifloxacin will be substituted for either ethambutol or
isoniazid, two drugs used in the current treatment that was developed
more than 40 years ago.
The clinical trials are part of a growing trend of partnerships under
which contributions from companies and academic centers are coordinated
and which now account for three-quarters of the neglected-disease drug
projects.
Under terms of this partnership, Bayer will donate moxifloxacin for each
trial site and cover the costs of regulatory filings. The TB Alliance
and its partners are helping to cover the cost of the trials and will
manage the trial program.
The Alliance and Bayer have agreed that if the treatment is registered,
they will make it available at affordable prices in the majority of the
world's low and lower-middle income countries.