]

TB Alliance and Partners Awarded Grant from NIAID to Speed TB R&D

CTB2 Consortium gains funds to search for TB biomarkers

March 13, 2012

The National Institute of Allergy and Infectious Diseases (NIAID) has awarded a grant to the TB Alliance as a member of the Consortium for TB Biomarkers (CTB2) project. The award, distributed over five years, will support the search for tuberculosis (TB) biomarkers, which are biological indicators that can measure the progress of disease or the effects of treatment, and are critical to markedly shortening the time to develop urgently needed new TB regimens.

CTB2 is a partnership composed of three organizations: TB Alliance, Center for Disease Control (CDC)’s TB Trials Consortium (TBTC), and NIAID’s AIDS Clinical Trials Group (ACTG). These organizations are central to conducting late-stage TB clinical trials and through that work, collect and process well-characterized clinical specimens, which are then stored in an international repository. The samples will be made available to researchers investigating biomarkers of TB treatment response on a peer-review basis.

“We applaud NIAID’s commitment to funding the search for tools that will lead to better, faster cures for TB,” says Mel Spigelman, MD, CEO and President, TB Alliance. “In the absence of biomarkers, patients treated in clinical trials must be followed for a year after completing treatment to ensure relapse does not occur. This requirement contributes to the length, cost, and practical challenges of clinical trials of new TB drugs.”

This collaboration’s search for biomarkers began in 2010 with seed funding from the FDA Office of Critical Path Programs. The grant from NIAID’s Division of Acquired Immunodeficiency Syndrome (DAIDS) allows CTB 2 to dramatically expand the number of samples that will be collected to obtain a robust repository that is representative of the global TB burden. The collection will play a critical role in the search for new TB biomarkers. This is the TB Alliance’s first grant from NIAID.

Biomarkers have transformed research and development for new drugs in various fields of medical research, including HIV/AIDS. For TB, biomarkers show promise to streamline pre-clinical and clinical development including shortening pivotal trials by 1-2 years, distinguishing patients who have achieved stable cure from those at high risk for relapse sooner, Such biomarkers will dramatically decrease the time needed for evaluation and ultimately, registration, of improved regimens for TB patients.