TB Alliance's REMox TB program leverages ACTG sites to advance testing of improved TB treatments
(Durban, SOUTH AFRICA, November 15, 2011) - The TB Alliance announces the launch of a collaboration with
the National Institute of Allergy and Infectious Diseases' (NIAID) AIDS Clinical Trial Group (ACTG) to conduct and help
complete a Phase III clinical trial testing potentially faster-acting tuberculosis (TB) treatments. Few clinical
trials for TB have been conducted under modern GCP/GCLP standards in the past 40 years, and the infrastructure
to support invigorated global TB drug research is lacking, especially in resource-limited settings where the
majority of TB cases are found. The partnership between the NIAID's ACTG and TB Alliance joins available
resources with the urgent need for TB clinical research capacity to accelerate testing of new therapies
that can benefit both the HIV/AIDS and TB communities.
TB and HIV/AIDS are sometimes called "the dual epidemic" because they can be fatally synergistic. TB is the leading
infectious killer of people with HIV/AIDS, especially in sub-Saharan Africa. Globally, one-third of the 33 million
people living with HIV/AIDS are also infected with the bacterium that causes TB. New and improved TB drugs are
desperately needed to treat patients suffering from HIV/TB co-infection.
The TB Alliance is currently enrolling patients in REMox TB, a global Phase III clinical trial, which is testing two
four-month moxifloxacin-containing treatment regimens for drug-sensitive (DS) TB against the standard six-month
therapy. Moxifloxacin has the potential to be the first new drug to treat DS-TB in more than 40 years,
offering the potential for a shorter therapy for the millions of TB and TB/HIV co-infected patients.
In order to help increase trial capacity to complete enrollment in the trial, four ACTG clinical
trials units will participate in REMox TB.
"This collaboration is a perfect example of how innovative and efficient resource sharing can benefit all parties involved-in
this case, the TB and the HIV/AIDS community, and especially those co-infected with TB and AIDS," said Dr. Mel Spigelman,
President and CEO, TB Alliance. "With this collaboration, ACTG enhances our collective capacity to more quickly evaluate
new TB drugs and regimens, which will result in improved therapies being available sooner for all TB patients,
including those co-infected with HIV."
The 4 new clinical trial sites that will participate in REMox TB are located in Africa, and include the UKZN-Durban
International Clinical Trials Unit, UKZN-CAPRISA-HIV/AIDS CTU, and Soweto CTU at PHRU in South Africa; and the Center
for Infectious Disease Research at the Kalingalinga ACTG Clinic in Zambia. Enrollment has begun in multiple sites in
Durban and will expand to the other sites in coming months.
"The new and expanding commitment by the U.S. National Institutes of Health to apply 21st century science to one of
humanity's oldest scourges, TB, by tackling the co-epidemics of HIV and TB where they are the worst, in many African
settings, has the promise of accelerating progress against both diseases," said Mark Harrington, Executive Director,
Treatment Action Group. "Activists, people with TB or HIV, researchers, and providers all welcome the expanded
involvement of the NIH-funded ACTG in studying new TB drugs and regimens, bringing closer the prospect that
we can eliminate them both in this century."
About the TB Alliance
The Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit organization dedicated to finding
faster-acting and affordable drug regimens to fight tuberculosis. Through innovative science and with partners
around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global
health and prosperity. The TB Alliance operates with funding from the Bill & Melinda Gates
Foundation, the United Kingdom Department for International Development, the United States
Agency for International Development, the European Commission, and the United States Food
and Drug Administration. For more information please
visit www.tballiance.org .
About REMox TB and moxifloxacin
REMox TB is a three-arm global Phase III study to in which moxifloxacin substitutes for two different drugs in the
current first-line standard TB therapy, ethambutol and isoniazid, and is administered for a total of four months.
REMox TB will determine whether either of these two new, four-month regimens are not inferior to standard
six-month therapy in terms of failure and relapse. The TB Alliance is conducting the REMox TB trial in
partnership with Bayer Healthcare AG, the University College of London, and the Medical Research
Council as well as other partners around the world in an effort to find shorter, faster-acting TB drugs.
Moxifloxacin is a fluoroquinolone - a subset of the quinolone class of antibiotics. Developed and marketed by
Bayer HealthCare AG, moxifloxacin has demonstrated efficacy for the treatment of several acute respiratory and
uncomplicated skin and soft tissue infections. It has been used more than 134 million patients, in 123
countries. Moxifloxacin is currently not registered to treat tuberculosis.
Contact: Joanna Breitstein
GCI Health- TB Alliance