TB Alliance Launches First Clinical Trial of a Novel TB Drug Regimen. Shobha Shukla


On the eve of the 41st Union World Conference on Lung Health, being held in Berlin, Germany (11-15 November 2010), the Global Alliance for TB Drug Development (TB Alliance) celebrated its 10th anniversary bash by announcing the launch of the first clinical trial to test a novel tuberculosis regimen, which shows a promise to treat both drug-sensitive (DS-TB) and multidrug-resistant TB (MDR-TB) with a single three-drug combination, reducing treatment duration of MDR-TB from 2 years to less than six months.
This Phase II trial, called NC001 or New Combination 1, tests the new TB drug candidates PA-824 and moxifloxacin in combination with pyrazinamide,This Phase II which show potential to shorten treatment time for virtually all tuberculosis patients and harmonize the treatment of DS-TB and MDR-TB-- an emerging global health threat. Both new compounds are being developed by the non profit organization TB Alliance, in partnership with Bayer HealthCare AG. The trials are going to begin at two centres in South Africa—one of the highest TB burden countries.
There is a desperate need for better and faster acting TB treatments to address today’s growing TB pandemic, which knows no boundary, and kills nearly 2 million people each year. It is the third leading cause of death among women of child-bearing age in the developing world and the leading killer of people with HIV/AIDS. Due to the length and complexity of the current TB treatment, many patients are unable to complete their treatment, leading to increasing drug resistance, an emerging global health threat. Hence this new initiative of TB Alliance, aptly called Critical Path to TB Drug Regimens, which was discussed at length at the Open Forum 4 Meet held three months ago in Ethiopia, assumes a lot of significance. It enables combinations of previously unregistered TB drugs to be tested together, with the goal of introducing truly innovative regimens in only a fraction of that time.
This research approach is being championed by the Critical Path to TB Drug Regimens, an initiative established to tackle the regulatory and other challenges associated with TB drug development. CPTR was founded in March 2010 by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance, and is supported by several pharmaceutical companies and civil society organizations. The US Food and Drug Administration, and the World Health Organization have all shown support for this initiative.
“We need more than a new drug to eradicate TB—we need entirely new regimens of TB drugs,” said Mel Spigelman, M.D., President and Chief Executive Officer, TB Alliance. “The potential to offer a single regimen to treat both drug-sensitive and multidrug-resistant TB represents a monumental advance in the treatment of patients worldwide, and a tremendous step toward simplifying the delivery of TB treatment globally.”
“New and powerful drugs to combat TB and MDR-TB are essential to achieving TB control goals outlined in the Global Plan to Stop TB 2011-2015 and ultimately to eliminate TB,” said Mario Raviglione, M.D., Director of the World Health Organization’s Stop TB Department. “It is extremely encouraging to see a growing pipeline of TB drug candidates that may revolutionize TB care and committed sponsors moving with speed and efficiency towards new regimens.”
Francis Apina, a TB activist from Kenya, rightly emphasized upon the meaningful participation of the community in promoting research for new and simpler drug regimens from the grass roots level, as they are the biggest stakeholder in the fight against tuberculosis.
It is hoped that the new drug regimens will not only make TB treatment simpler, but also more cost effective, so that they reach the most vulnerable sections of society, and do not remain the property of a select few.

(The author is the Editor of Citizen News Service (CNS) and also serves as the Director of CNS Diabetes Media Initiative (CNS-DMI). Email: shobha@citizen-news.org, Website: www.citizen-news.org )

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