
In this week’s TB R&D update, we look at whether researchers should change their view and definitions of immunopathology in tuberculosis. The authors suggest that the term “caseous necrosis” should actually be split into three processes. The article is published in the February issue of Science Translational Medicine and is entitled “Tuberculosis immunopathology: the neglected role of extracellular matrix destruction.” Also, links to additional news in TB R&D are included.
The clinical trial of the first novel regimen was featured today on SABC TV in South Africa. This is the first clinical trial to test multiple new TB drugs in combination; the trial is known as New Combination 1 (NC001). The experimental regimen undergoing testing in this trial consists of experimental TB drugs PA-824, Moxifloxacin, and Pyrazinamide, an antibiotic commonly administered as part of current TB treatment.
Today, the TB Alliance announced the first clinical trial to test multiple new TB drugs in combination; the trial is known as New Combination 1 (NC001).The experimental regimen undergoing testing in this trial consists of experimental TB drugs PA-824, Moxifloxacin, and Pyrazinamide, an antibiotic commonly administered as part of current TB treatment. This regimen has shown potential to harmonize treatment for TB drug-sensitive tuberculosis (DS-TB) and multidrug-resistant tuberculosis (MDR-TB) under a single three-drug regimen.
The novel antitubercular agent TMC207 (Tibotec, a Johnson & Johnson company) represents an impressive and important new chemical agent for addressing both drug sensitive and drug resistant TB. This compound – which is continuing to advance through clinical trials conducted by both J&J and the TB Alliance – selectively inhibits M.tb ATP synthase leading to disruption in the energy metabolism of both replicating and non-replicating organisms.
From Citizen News Service: The Open Forum 4 on key issues in tuberculosis (TB) drug development is all set to begin in Addis Ababa, Ethiopia (18-19 August 2010). This Open Forum 4, will raise and address key issues in TB drug development, with a special focus on regulatory affairs. The Forum will include sessions on the current global TB drug development portfolio, key issues in the critical path to TB drug registration, designing pivotal trials, conducting registration trials in high TB burden countries, challenges in TB drug development for resistant disease and developing regimens containing multiple novel agents.
New York, United States and Geneva, Switzerland — July 7, 2010 The TB Alliance and Drugs for Neglected Diseases Initiative (DNDi) announced today a unique first-ever royalty-free license agreement between two not-for-profit drug developers that speeds progress toward markedly improved therapy of multiple neglected diseases.
Dr. Martino Laurenzi, an expert in clinical development and community health, is a Clinical Research Scientist at the TB Alliance, where his responsibilities include the oversight of clinical trials. Dr. Laurenzi has long been involved in public health research; the Gubbio Study, which he started in 1982 in the Italian town for which it is named, is one of the longest standing population-based epidemiological studies for the screening of cardiovascular risk factors.
Community engagement in TB drug research is growing practice, made possible by the fact that several new drug candidates are entering clinical trials. This roundtable will provide a forum for dialogue between researchers, community members, CBOs/NGOs, and advocates about methods for effective community engagement in TB research. Panelists representing several viewpoints will highlight successful practices for encouraging stakeholder involvement in research and discuss how communities can influence national policies and procedures to ensure the rapid adoption and roll-out of new TB regimens, once available.