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Phase IIb Proof of Concept Trial Planned for Kenya, India and South Africa
ROCKVILLE, Md., Oct. 10, 2012 /PRNewswire-USNewswire/ -- Aeras announces that it has signed an agreement with GlaxoSmithKline Vaccines, S.A. (GSK) to jointly advance the clinical development of an investigational tuberculosis (TB) vaccine containing GSK's proprietary M72 antigen and AS01E* adjuvant. This novel research and resource-sharing agreement between the largest non-profit TB vaccine biotech and one of the world's leading research-based pharmaceutical and healthcare companies marks advancement in the race to develop new vaccines against TB, a global infectious disease killer.
"This partnership signals our commitment to building innovative collaborations to develop and deliver new TB vaccines," said Jim Connolly, President and Chief Executive Officer of Aeras. "We will never reverse the spread of the global TB epidemic without new vaccines as part of the solution."
The new agreement comes after promising results from early stage clinical trials showed that the GSK TB vaccine candidate known as M72/AS01E* has an acceptable safety and reactogenicity profile and demonstrated an immune response. Under the new agreement, Aeras and GSK will each provide resources to run a multi-center proof of concept clinical trial to test the vaccine candidate in healthy adults between 18 and 50 years of age. The Phase IIb trial is scheduled to begin in Kenya, India and South Africa next year pending approvals from authorities.
"When considering the massive public health impact and costs to society of neglected diseases including tuberculosis, global financing for R&D remains critically low in this area," said Jim Connolly. "Working in partnership with GSK – sharing resources, capabilities and know-how – affords us the opportunity to conduct this pivotal, multi-country proof of concept trial, getting us that much closer to potentially one day having a TB vaccine that could protect adolescents and adults from one of the world's deadliest infectious diseases."
TB continues to kill 1.4 million men, women and children annually, despite the widespread use of the currently available TB vaccine, Bacille Calmette-Guerin (BCG), in TB endemic countries. BCG prevents some forms of TB in infants but does not prevent pulmonary TB, which accounts for the majority of infections and deaths among adolescents and adults. The GSK vaccine candidate developed under this new agreement is being designed to be used in addition to BCG.
*Contains QS-21 Stimulon® adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN).
Tuberculosis is the world's second deadliest infectious disease, with 8.8 million new cases in 2010. Current guidelines require a minimum of six to nine months of treatment. TB is changing and evolving, making new vaccines more crucial for controlling the pandemic. Tuberculosis is the leading cause of death for people living with HIV/AIDS, particularly in Africa. Multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) are hampering treatment and control efforts.
Aeras is the world's largest and only fully integrated tuberculosis vaccine development organization dedicated to addressing a disease that has chronically infected almost a third of the world's population. In collaboration with global partners in Africa, Asia, North America and Europe, Aeras is supporting the clinical testing of six vaccine candidates as well as a robust portfolio of preclinical candidates. Aeras is a nonprofit organization and receives funding from the Bill & Melinda Gates Foundation and other private foundations as well as a wide range of governments. Aeras is based in Rockville, Maryland, USA where it operates a state-of-the-art manufacturing and laboratory facility, and Cape Town, South Africa. For more information, see www.aeras.org.