New TB treatment on trial

Tuesday, November 9, 2010

Pretoria - A new drug treatment with the potential of simplifying and shortening TB treatment from two years to less than six months, is currently been tested on patients at two centres in South Africa.

The announcement of the first-ever clinical trial of a novel TB drug was made on Monday by Global Alliance for TB Drug Development, a non- profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis.

The trial, which will take place at the Lung Institute at the University of Cape Town and the TASK Research Center in Belville, involves 68 participants, each receiving two weeks of treatment and three months of follow-up to evaluate effectiveness, safety, and tolerability.

This novel three-drug combination shows promise to treat both drug-sensitive (DS-TB) and multidrug-resistant TB (MDR-TB), and alter the course of the TB pandemic by shortening and simplifying treatment worldwide.

This is a particularly significant advance for MDR-TB patients, who today must take multiple types of drugs, including injectables, daily for up to two years.

The Phase II trial called NC001 or New Combination 1, tests the new TB drug candidates PA-824 and moxifloxacin in combination with pyrazinamide, an existing antibiotic commonly used in TB treatment today.

If successful, the experimental regimen will offer a shorter, simpler, safer, and more affordable treatment option for MDR-TB, an emerging global health threat.

The Department of Health has welcomed the development of the new drugs, noting that it will not only benefit South Africa but the whole world in their fight against TB.

"We welcome the fresh development, which will assist in bringing down the period of taking the treatment, which is one of the main reasons for patients defaulting. The development is also more important for us [South Africa] because of the high burden of TB," said department spokesperson Fidel Hadebe.

TB Alliance Managing Director and CEO Mel Spigelman said they need more than a new drug to eradicate TB and need entirely new regimens of TB drugs.

"The potential to offer a single regimen to treat both DS and MDR-TB represents a monumental advance in the treatment of patients worldwide and a tremendous step toward simplifying the delivery of TB treatment globally," said Spigelman.

He noted that treating active TB requires a combination of drugs to prevent the development of drug resistance adding that traditionally, researchers tested one new drug at a time in a series of lengthy and expensive clinical trials, meaning it would take decades to develop a completely novel drug combination.

World Health Organisation's Stop TB Department Managing Director, Mario Raviglione said there was a desperate need for new and better TB treatments to address today's growing pandemic, which kills nearly two million people each year.

He said with increased investments in TB, there are nine promising TB compounds in the pipeline from six antibiotic classes, making combination testing of new TB drugs possible.

"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," said Raviglione.