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New TB Drug Shows Promise In Clinical Trials

By Chrissie Cole

LEARN MORE NEJM, June 2009 J&J Press Release InjuryBoard on Tuberculosis WHO on Tuberculosis IMAGE SOURCE: © Wikimedia Commons/ lungs/ author: Gray's Anatomy

First New Tuberculosis Drug in 40 Years

The results of an ongoing study of the experimental drug TMC207 have been released, by Johnson & Johnson. The drug will be used for the treatment of multidrug-resistant tuberculosis (MDR-TB).

Johnson & Johnson tested TMC207 in a Phase 2 trial of 47 South African patients with newly diagnosed MDR-TB of the lungs. Half of them received the experimental drug while the rest received placebo for an eight week period; all patients took a standard regimen of five existing TB drugs.

Researchers found a greater proportion of patients who received TMC207 tested negative for TB in lung-fluid cultures after eight weeks, compared to the placebo (48% versus 9%).

TMC207 also reduced the time from start to treatment to conversion of cultures to negative. Adverse events were generally similar between both the placebo and TMC207 groups, writes WSJ.

TMC207 works by cutting of the energy supply in the bacteria that causes tuberculosis. TMC207, the first of a new class of drugs, has the potential to enable treatment options for patients who have drug-resistant tuberculosis, for whom current therapy has proved ineffective or highly toxic.

J&J expects to file for regulatory approval of TMC207 in 2011.

Tuberculosis is an airborne infectious disease that usually attacks the lungs. Laughing, sneezing even talking can spread the germs through the air. Repeated contact is required for infection.

Symptoms include a persistent cough, constant fatigue, weight loss, a loss of appetite, fever, coughing up blood and night sweats, according to the American Lung Association.

As the disease progresses, the bacteria can spread throughout the body affecting a wide array of organs and systems including the kidneys, bladder, brain, joints, reproductive organs, and spine.

Each year, there are an estimated 9 million new TB cases, of which 490,000 are multiple-drug-resistant TB, according to the World Health Organization. #

Originally posted at Chrissie Cole

Full post as published by West Virginia Personal Injury Lawyer on June 04, 2009 (boomark / email).