TB trial demonstrates the role of Critical Path for TB Drug Development

An ongoing trial involving the use of three new drugs for tuberculosis, along with one still used in standard therapy, demonstrates the role of the Critical Path for TB Drug Development in studies that combine more than one investigational drug.

The Critical Path to TB Drug Regimens was developed by the Critical Path Institute to bring the U.S. Food Drug Administration and various sponsors together to discuss emerging science, including combination trials, according to the Pink Sheet.

The Critical Path to TB Drug Regimens is organized into three arms to make it effective in separate areas - liability, business development and regulations. Each arm represents the combined knowledge of each partner in that field.

The approach succeeded in bringing Johnson & Johnson, Bayer, Sanofi-Aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals into the combination drug project. The World Health Organization and the National Institutes of Health’s National Institute of Allergy and Infectious Diseases are also on board.

"But we have to maintain a wall," Raymond Woosley, the Critical Path Institute's president and chairman of the board, said, according to the Pink Sheet. "We're not sponsoring the trial and have not even seen the protocol, though we are urging them to use the most modern methods. We don't sponsor trials. We work on the process, not the product."

The ramifications of the success or failure of early-phase combination treatments extend beyond TB and could lead to treatments for illnesses like AIDS, which already uses the cocktail approach to antiviral therapies.

"We've recruited outstanding people and have held test meetings to see if the global TB community is ready to work together," Woosley said. "What do we do to bring together expertise to new testing approaches for TB?"