FDAnews
www.fdanews.com/articles/81757-tb-alliance-and-bayer-launch-global-drug-trials-for-tuberculosis

TB ALLIANCE AND BAYER LAUNCH GLOBAL DRUG TRIALS FOR TUBERCULOSIS

October 18, 2005

The Global Alliance for TB Drug Development (TB Alliance) and Bayer Healthcare have announced a partnership to coordinate a global clinical trial program to study the potential of an existing antibiotic, moxifloxacin, to shorten the standard six-month treatment of tuberculosis (TB).

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 U.S. and Zambia.

The Phase II clinical trial program spans four continents and will enroll close to 2,500 patients with TB. The trials will evaluate whether the substitution of moxifloxacin for one of the standard TB drugs (ethambutol or isoniazid) eliminates TB infection faster than the current standard therapy.