A phase III trial of a novel combination of TB drugs will launch within the year, the TB Alliance has announced
Treatment times for tuberculosis, including some of the drug resistant strains could be dramatically shortened. A new trial of a novel drug combination will start at some point this year, as long as enough money can be raised to fund the trial.
The phase III trial called STAND has been given the green light to start in 10 different countries. With tuberculosis killing 1.4 million people a year, the new trial has been warmly welcomed by campaigners and clinicians. With current drugs used in treatments being over fifty years old, its no wonder why they no longer adequate. Drug resistance is a growing and fearful issue. Some of the antibiotics needed to treat the resistant strains of tuberculosis are expensive and not readily available in the developing world. Even countries which have these specific drugs find that treatment can take the best part of two years.
If this growing global TB epidemic is to be contained and turned around novel drugs are vital. The TB Alliance announced the new trial, which will be carried out by partners around the world. STAND brings a completely new approach to the treatment of tuberculosis. TB normally needs to be treated by a cocktail of drugs to prevent resistance however instead of trialling one drug at a time against TB, STAND will test three in combination.
The new combined treatment called PaMZ, consists of two new drug candidates. PA-824, moxifloxacin and pyrazinamide, which is currently used against the disease. They have had success in smaller trials. If it works, it would cut the length of a course of pills for TB from six months to four and for MDR-TB from 18-24 months down to six months. Also there will be no longer the need for daily injections for MDR-T, the Alliance says the patients will be taking 360 pills or less instead of more than 14,000 over the course of their treatment.
The Bill and Melinda Gates Foundation, a key funder of the TB Alliance along with the UK’s Department for International Development, the United States Agency for International Development and other bodies, is supplying extra funding in to make the trial happen, but more is needed. Dr Mel Spigelman, president and CEO of TB Alliance said: “We thank all our supporters to date, as without their investment, the highly promising PaMZ regimen would not have reached this critical stage. We need new and expanded commitments for the STAND trial, however, if we are to realise the significant potential of this treatment to save millions of lives.”