Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Promising new TB drug enters clinical trial

15.06.2005


A promising new drug candidate that may be effective against both actively dividing and slow-growing Mycobacterium tuberculosis (M. tb) has begun testing in humans, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced today. The novel antibiotic, PA-824, may shorten the time needed to treat tuberculosis (TB), a contagious disease that claims approximately two million lives worldwide each year. In partnership with the non-profit New York-based Global Alliance for TB Drug Development (TB Alliance), NIAID contributed to the drug candidate’s preclinical safety and efficacy testing in animal models. Now, a clinical trial to assess PA-824’s safety, sponsored by the TB Alliance, has opened at a medical clinic in Lincoln, NE.

"The rapid movement of PA-824 through the development pipeline is a testament to the successful partnership between NIAID and the TB Alliance. It marks a significant milestone in progress toward our goal of making treatments for TB more effective and shorter in duration," notes NIAID Director Anthony S. Fauci, M.D.

One-third of the global population--some two billion people--is infected with M. tb. A person may remain latently infected and harbor the bacteria, in a non-growing or slow-growing form, for decades with no symptoms. However, if the immune system is weakened by age, HIV or other infections, M. tb may be re-activated and the active form of the disease may emerge. Although most common in other countries where HIV prevalence is highest, approximately 14,000 cases of active TB are reported to the Centers for Disease Control and Prevention each year in the United States.



While TB is curable with antibiotics, the drug regimen is arduous and lengthy. The World Health Organization’s current recommendation for treatment of active TB includes the administration of up to 4 drugs for at least 6 months. PA-824 differs from most currently available TB drugs because it appears to attack M. tb in both the bacterium’s actively dividing and slow-growing stages. For this reason, researchers hope PA-824 will significantly reduce the time needed to cure TB.

In 2000, C. Kendall Stover, Ph.D., of Pathogenesis Corporation, and his co-authors, including NIAID scientist Clifton E. Barry, III, Ph.D., published the first evidence of PA-824’s potential TB-fighting abilities. In 2002, the TB Alliance acquired exclusive worldwide rights to PA-824 from the California-based biotechnology firm, Chiron Corporation.

NIAID provided support to the TB Alliance for continued development of PA-824 through the Institute’s Tuberculosis Antimicrobial Acquisition and Coordinating Facility (TAACF) (www.taacf.org). TAACF, established by NIAID in 1994, conducts prescreening and efficacy testing of potential anti-TB drugs at no cost to those who submit the compounds.

For PA-824 development, NIAID support included

  • A contract awarded to Doris Rouse, Ph.D., of RTI International in Research Triangle Park, NC, that provided technology transfer assistance and project management of preclinical testing of the compound
  • A contract to Ian Orme, Ph.D., of Colorado State University that confirmed the efficacy of the compound in animal models of TB infection

"Several characteristics of PA-824 that emerged during preclinical testing give us reason to be optimistic about its possible effectiveness against TB in humans," says Dr. Barbara Laughon, Ph.D., chief of the Complications and Co-infections Branch of NIAID’s Division of AIDS. In addition to activity against both actively dividing and slow-growing M. tb, PA-824 also shows evidence of being active against both drug-sensitive and multi-drug-resistant TB. Also, in animal testing, single doses of the compound administered orally traveled rapidly to such target organs as the lung and spleen. With support from both the TB Alliance and NIAID, Jacques Grosset, M.D., and William Bishai, M.D., Ph.D., of The Johns Hopkins University in Baltimore, found PA-824 to have bacterial killing effects similar to frontline TB drugs isoniazid and rifampin in animal models of infection. Finally, PA-824’s apparent lack of interaction with certain liver enzymes means it may be safe for use by people co-infected by HIV and TB. Currently, such individuals may experience adverse effects when taking both rifampin (to treat TB) and antiretroviral drugs (to treat HIV).

"The announcement that a novel TB drug candidate has entered human trials is cause for celebration in the TB community. It underscores the value of public-private partnerships and the crucial role of NIAID’s TB drug development contract mechanism in preparing PA-824 for this stage," says Dr. Laughon.

Adds Maria C. Freire, Ph.D, president and chief executive officer of the TB Alliance, "We worked creatively and smartly with our partners, donors and contractors, combining our ability to move the technology forward with the expert management of RTI International and all of NIAID’s contributions. The result is that a promising TB compound moved into human trials in near-record time."

Anne A. Oplinger | EurekAlert!
Further information:
http://www.niaid.nih.gov

More articles from Life Sciences:

nachricht New way to look at cell membranes could change the way we study disease
19.11.2018 | University of Oxford

nachricht Controlling organ growth with light
19.11.2018 | European Molecular Biology Laboratory

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: UNH scientists help provide first-ever views of elusive energy explosion

Researchers at the University of New Hampshire have captured a difficult-to-view singular event involving "magnetic reconnection"--the process by which sparse particles and energy around Earth collide producing a quick but mighty explosion--in the Earth's magnetotail, the magnetic environment that trails behind the planet.

Magnetic reconnection has remained a bit of a mystery to scientists. They know it exists and have documented the effects that the energy explosions can...

Im Focus: A Chip with Blood Vessels

Biochips have been developed at TU Wien (Vienna), on which tissue can be produced and examined. This allows supplying the tissue with different substances in a very controlled way.

Cultivating human cells in the Petri dish is not a big challenge today. Producing artificial tissue, however, permeated by fine blood vessels, is a much more...

Im Focus: A Leap Into Quantum Technology

Faster and secure data communication: This is the goal of a new joint project involving physicists from the University of Würzburg. The German Federal Ministry of Education and Research funds the project with 14.8 million euro.

In our digital world data security and secure communication are becoming more and more important. Quantum communication is a promising approach to achieve...

Im Focus: Research icebreaker Polarstern begins the Antarctic season

What does it look like below the ice shelf of the calved massive iceberg A68?

On Saturday, 10 November 2018, the research icebreaker Polarstern will leave its homeport of Bremerhaven, bound for Cape Town, South Africa.

Im Focus: Penn engineers develop ultrathin, ultralight 'nanocardboard'

When choosing materials to make something, trade-offs need to be made between a host of properties, such as thickness, stiffness and weight. Depending on the application in question, finding just the right balance is the difference between success and failure

Now, a team of Penn Engineers has demonstrated a new material they call "nanocardboard," an ultrathin equivalent of corrugated paper cardboard. A square...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Optical Coherence Tomography: German-Japanese Research Alliance hosted Medical Imaging Conference

19.11.2018 | Event News

“3rd Conference on Laser Polishing – LaP 2018” Attracts International Experts and Users

09.11.2018 | Event News

On the brain’s ability to find the right direction

06.11.2018 | Event News

 
Latest News

New materials: Growing polymer pelts

19.11.2018 | Materials Sciences

Earthquake researchers finalists for supercomputing prize

19.11.2018 | Information Technology

Controlling organ growth with light

19.11.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>