University Hospitals (UH) Case Medical Center will begin a Phase 1 clinical trial on a new experimental anti-tuberculosis drug called TMC207. This drug represents the first new class of anti-TB drugs in the past 60 years and it has activity against both drug-susceptible and drug-resistant TB.
The study is the first trial under a seven-year, $16.8 million contract awarded from the National Institutes of Health through the Hinckley-based research organization research organization Clinical Research Management (CRM) to UH Case Medical Center, Case Western Reserve University and Johns Hopkins University for first- in-human studies of new drugs for emerging infectious diseases.
TMC207 will be tested in 32 healthy individuals for its safety and tolerability, and to determine if its pharmacological activity is affected by repeat doses of other anti-TB drugs, rifabutin and rifampin, which are already in use and are often used in combination for treating TB.
The study will be led by Dr. Robert Salata, chief of the Division of Infectious Diseases at UH Case Medical Center and professor of medicine at Case Western Reserve University School of Medicine.
TB remains a major scourge. One third of the world's population is thought to be infected with it.