Enrollment Complete for REMox TB: Global Phase III Clinical Trial
TB Alliance and partners achieve major milestone in pursuit of first new TB drug in nearly 50 years
New York — 1 February 2012 The TB Alliance and partners have completed patient enrollment in REMox TB, a global Phase III clinical trial, which may result in the registration of the first new drug approved for the treatment of drug-sensitive TB in nearly 50 years. REMox TB was designed to test whether a moxifloxacin-containing treatment regimen of just four months can cure drug-sensitive TB patients at rates that are non-inferior to those achieved with the standard six-month TB regimen. In total, more than 1,900 patients were enrolled in REMox TB. Those involved in REMox TB have expressed satisfaction and pride in their participation.
REMox TB is a global endeavor that brought together a wide array of partners and stakeholders, from an international pharmaceutical company to local community leaders in the areas surrounding trials sites. Initiated in 2008 by the TB Alliance, Bayer Healthcare, University College London, University of St Andrews and the United Kingdom Medical Research Council, REMox TB has helped build the capacity for clinical TB drug research in three continents, strengthened ties between researchers and local communities through its associated Community Engagement Program, and built bridges with the HIV research community through its use of United States National institutes of Health (NIH) AIDS Clinical Trial Group (ACTG) clinical trial sites. The REMox TB trial was funded by the Bill & Melinda Gates Foundation, European and Developing Countries Clinical Trials Partnership (EDCTP), Irish Aid, the United Kingdom Department for International Development (DFID), and the United States Agency for International Development (USAID).
Phase III trials testing TB drugs require the evaluation of trial participants for one year following their completion of treatment to ensure patients do not relapse. Completion of treatment and routine monitoring should be complete in mid-2013. If the data from the clinical trial is positive, TB Alliance and Bayer Healthcare will seek registration of moxifloxacin as part of a multi-drug regimen for drug-sensitive TB and work to make it widely adopted into existing TB treatment programs, and available and affordable to patients who most need it. If successful, registration of moxifloxacin is expected in 2014. It is critical that TB programs and their global supporters begin to establish the financing, systems, and structures to review and consider policy change in order to ensure patients can access the new regimen as soon as it is proven and available.
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Click to read a statement from Bayer HealthCare
Click to read a statement from EDCTP
Click to read a statement from KEMRI
Click to read a statement from University of St. Andrews
Click to read a statement from University College of London