TB drug trials in 'high gear'

Reprinted from IOL: News for South Africa and the World

November 08 2007 at 10:42AM

By Liz Clarke

The trail-blazing development of new drugs, which could help revolutionise tuberculosis treatment and save millions of lives in South Africa and the rest of the world, was announced in Cape Town on Thursday.

Scientists attending the 38th Union Conference on lung health at the Cape Town International Convention Centre say two drugs with "incredible promise" are advancing in clinical trials in TB patients.

Dr Maria Freire, CEO and president of the Global Alliance for TB Drug Development (TB Alliance) described the research advances as "an historic milestone" in the accelerated drive to halt the catastrophic number of lives still lost through a disease which, when treated correctly, is curable.

For thousands of TB sufferers, many with drug-resistant strains, a new arsenal of drugs is the life-saver they have been hoping and praying for.

Said a Khayelitsha clinic sister: "To tell someone there are no other drugs left is heart-breaking. Now we are seeing some light. This is great news."

One of the drugs, known as PA-824, is the first novel TB drug, developed on a not-for-profit basis, to enter testing in TB patients.

A second drug, moxifloxacin, while widely prescribed for respiratory ailments, is being tested as a new treatment option for TB combination therapy.

Moxifloxacin is entering a pivotal large Phase III clinical trial, beginning at six sites in South Africa, Tanzania, Kenya and Zambia.

If the substitution of moxifloxacin for an existing drug proves effective, approval from regulatory bodies could begin as early as 2010.

Research scientists at the TB Alliance said fast-tracking of new drug regimens is essential to help halt what the World Health Organisation has called an unfolding global tragedy.

Dr Mel Spigelman, the TB Alliance's Director of Research and Development said there was a global commitment to change the Cinderella status of TB.

"Powerful partnerships are making things happen," he said. "Scientists, pharmaceutical companies, global authorities are paving the way for a dynamic new approach to the way we treat TB.

"I would say we are in high gear. Instead of up to 24 years to get drugs tested and approved, we are working to speed up the process dramatically, still ensuring ethics, safety and efficacy."

The TB Alliance is a not-for-profit, public-private product development partnership, backed among others by the Bill and Melinda Gates Foundation.

Commenting on the drug announcement, Professor Anthony MBewu, President of the South Africa Medical Research Council and a member of the TB Alliance Board of Directors said the development of faster, simpler drug regimens was essential to eliminating the needlessly high burden of TB in Africa and around the world.

The conference, which has drawn more than 3 000 delegates from across the world, will also be looking at revolutionary new diagnostic tools for TB, which have not changed over the past 100 years.