Washington, July 24 (ANI): Results of a Phase II clinical trial has shown that a novel tuberculosis (TB) combination drug regimen could be more effective than existing treatments.
It was found that this novel combination could kill more than 99 percent of patients' TB bacteria within two weeks.
These results add to a growing body of evidence that the new regimen could reduce treatment by more than a year for some patients.
The findings from researchers and the non-profit TB Alliance raise hope for a treatment breakthrough amid the growing and dangerous epidemic of drug-resistant forms of TB that, in some cases, are becoming untreatable.
The results, presented at the 2012 International AIDS Conference, also reveal progress in the pursuit of an antiretroviral-compatible TB treatment, which is critical to treating the millions of people with TB/HIV co-infection. Today, TB remains the largest killer of people with AIDS, but very often, TB and HIV treatments cannot be given together because of drug-drug interactions and side effects.
The clinical trial tested a combination of one completely novel drug candidate, a new TB drug candidate already approved to treat other infectious diseases, and one existing TB drug. These results, along with pre-clinical data, suggested that this novel combination could treat both drug-susceptible and some forms of drug-resistant TB in only four months.
Currently, people with multi-drug resistant TB (MDR-TB) require 18 to 24 months of treatment. Even those with ordinary TB need six months of taking drugs every day.
"These findings confirm the promise of novel TB regimens to be shorter, simpler, safer, and, compared with today's MDR-TB drugs, much less expensive," said Mel Spigelman, MD, CEO and President of TB Alliance.
"The next trial to advance this regimen is already underway. We now have real momentum toward bringing to market treatments that will ultimately help save millions of lives," he noted.
The study, NC-001, or New Combination 1, was a two-week trial successfully completed at two centers in South Africa. It involved the new combination therapy called PaMZ, consisting of the novel TB drug candidate, PA-824; moxifloxacin, an established antibiotic not yet approved for use in first-line TB therapy and being developed in partnership with Bayer Healthcare AG; and pyrazinamide, an existing TB drug.
A second trial called New Combination 2 (NC-002) was launched earlier this year to test the PaMZ combination over two months in patients, further advancing it through clinical development.
NC-002 is currently enrolling patients and will be conducted at eight sites in South Africa, Tanzania and Brazil, and will build global capacity for TB trials.
In addition to these results, pharmaceutical companies are seeking regulatory approval for individual TB drug candidates-advances made possible by the existence of the most promising research pipeline for TB drugs in history. TB experts say any new drugs for tuberculosis would be an extraordinary development, but that new TB drug combinations are potential game-changers due to their expected impact.
The study has just been published in the Lancet. (ANI)
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