Newswise — The global effort to provide affordable medicines to people in developing nations moved a step forward this week, when the nonprofit Global Alliance for TB Drug Development (TB Alliance) announced that the lead drug in its pipeline, PA-824, began Phase I clinical trials this month.
Research studies in animals have indicated that this compound has the potential to shorten treatment of tuberculosis (TB) and to be effective against drug-resistant strains of TB.
The announcement signaled not only the first time a TB drug developed by a nonprofit has begun clinical trials, but also provided evidence that a new model for developing drugs through public-private partnerships has the potential to bring new, affordable medicines to those most in need.
"Reaching this milestone greatly enhances the chances of improved TB treatment and is an important advance in the TB community's drive for a faster cure," said Dr. Maria C. Freire, TB Alliance president and CEO. "We worked creatively and smartly with our partners, donors and contractors. The result is that an extremely promising TB compound moved from lead identification into human trials in near record time."
For RTI International's Dr. Doris Rouse, who managed the development of PA-824 for the TB Alliance under a contract with the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases, the drug development process used in this case may prove as significant in the long run as the drug itself.
"Everyone recognizes the challenge of developing and providing new affordable medicines to the world's poorest populations," said Rouse, who directs RTI's Global Health Technologies Program. "This project proves that by working creatively and in collaboration with a variety of international public and private entities we can overcome these challenges and, in time, bring other badly needed medicines through the drug development pipeline."
Rouse's work on tuberculosis began in 1999, when she and a team of RTI researchers were awarded a contract from the National Institute of Allergy and Infectious Diseases to help accelerate commercial availability of tuberculosis treatments developed in industry, university and government laboratories.
Since 2000, the RTI team has supported TB Alliance's efforts to identify promising drug compounds and stimulate the involvement of pharmaceutical companies in developing new and affordable TB medicines. Rouse managed a global program for development of PA-824 that included 26 institutions in nine countries.
While the rate of TB infections in the United States has declined significantly in recent years as a result of TB control efforts by public health officials, the U.S. Centers for Disease Control and Prevention's most recent surveillance data (2003) indicate the rate of decline is slowing.
During 2002, the most recent data available, deaths resulting from TB in the United States increased by 5 percent; it was also the first time the number deaths from TB in the U.S. had increased since 1989. Equally alarming to U.S. and international public health officials, the disease is becoming increasingly resistant to existing drug treatments and is also a leading cause of death among people living with HIV/AIDS, whose compromised immune systems are unable to fight the disease.
For infectious, active TB, the current treatment takes six months and requires a combination of four medications as well as monitoring by medical personnel. Thus, any treatment that reduces the time required to treat TB cases could help reduce associated treatment costs and increase the number of people who complete the treatment.
"The start of Phase I clinical trials for PA-824 offers at least a bright spot on the long road to providing shorter and more effective TB treatments," Rouse said. "We at RTI are proud to have been a part of this effort."
About RTI InternationalRTI International is an independent nonprofit research organization dedicated to conducting research and development that improves the human condition. With a staff of more than 2,500 people, RTI offers innovative research and technical solutions to governments and businesses worldwide in the areas of health and pharmaceuticals, advanced technology, surveys and statistics, education and training, economic and social development, and the environment. For more information, please visit us at: http://www.rti.org.
About the National Institute of Allergy and Infectious DiseasesThe National Institute of Allergy and Infectious Diseases (NIAID) is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.
About the Global Alliance for TB Drug DevelopmentThe Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit, public-private partnership accelerating the discovery and/or development of affordable, new anti-TB drugs. Such drugs promise to shorten treatment, be effective against multi-drug resistant strains, and improve treatment of latent infection. In collaboration with public and private research laboratories worldwide, it is leading the development of the most comprehensive portfolio of TB drug candidates in four decades. The TB Alliance operates with the support of the Bill and Melinda Gates Foundation, the Rockefeller Foundation, the U.S. Agency for International Development, and the Netherlands Ministry for Cooperation Development.
RSS