February 16, 2004
BERLIN, 16 February 2004—German scientists, working as part of an international partnership, are beginning the country’s first human trial of a vaccine candidate designed to prevent AIDS. A preventive vaccine is widely considered the best hope to stop the epidemic’s continuing spread.
The trial will be conducted at two sites: Universitätsklinikum Bonn and Universitätsklinikum Eppendorf in Hamburg. The universities are partnering with the not-for-profit International AIDS Vaccine Initiative (IAVI), the biotechnology company Targeted Genetics Corp. (NASDAQ: TGEN) and Columbus Children’s Research Institute (CCRI).
Government regulatory approval to begin the trial has been granted by the Kommittee fuer Somatische Gentherapie (KSG).
Dr. Jan van Lunzen, MD, serves as Principal Investigator of the trial. Dr. van Lunzen said: “Preventive vaccines have ended smallpox, nearly eradicated polio and controlled dozens of other deadly diseases. With this new trial in Germany, we bring the world a step closer to a vaccine that will end AIDS.”
The vaccine candidate being tested in the trial is named tgAAC09. It was designed by Targeted Genetics and CCRI. tgAAC09 attempts to elicit immune system responses to prevent people from becoming infected with HIV and developing AIDS.
IAVI provides full financial support for the research and development of tgAAC09. Dr. Seth Berkley, MD, President and CEO of IAVI, said: “We are pleased that Germany’s top scientists are joining the global effort to develop a preventive AIDS vaccine. Their commitment is crucial as we speed progress toward a vaccine.”
Deutsche AIDS Stiftung (DAS), Germany’s national AIDS advocacy group, hailed the start of the trial: “We will win against AIDS only by fighting on multiple fronts. As Germany works to blunt AIDS with existing tools, we must also search for new tools, chief among them a preventive vaccine,” said Ulrich Heide, Chief Executive Officer of DAS.
The trial is also being conducted in Belgium. The trial will enroll up to 50 volunteers, men and women, in Germany and Belgium combined. It will test the safety of tgAAC09 and if it elicits immune responses. If so, tgAAC09 may advance to more and larger trials.
Each day, 14,000 people become infected with HIV, 95% in developing countries. Worldwide, IAVI estimates, roughly 25 preventive vaccine candidates are in human trials on six continents. Five of these advanced from the concept stage to trials with IAVI support.
IAVI is a global not-for-profit organization working to speed the search for a vaccine to prevent HIV infection and AIDS, focusing on developing countries. Founded in 1996 and operational in 22 countries, IAVI and its network of scientific partners research and develop AIDS vaccine candidates. IAVI also works to assure that a vaccine will be globally accessible. IAVI’s major financial supporters include the Bill & Melinda Gates Foundation; the Rockefeller, Sloan and Starr foundations; the World Bank; BD (Becton, Dickinson & Co.); the European Commission; and the governments of Canada, Denmark, Ireland, the Netherlands, Norway, Sweden, the United Kingdom and the United States.
About Targeted Genetics
Targeted Genetics Corp. (NASDAQ:TGEN; www.targetedgenetics.com) develops gene-based products for preventing and treating acquired and inherited diseases. The Company has two clinical product development programs, targeting cystic fibrosis and AIDS prophylaxis, and expects to initiate clinical testing of its arthritis product candidate in the first quarter of 2004. The Company also has a promising pipeline of product candidates focused on hemophilia and cancer and a broad platform of gene delivery technologies as well as a promising body of technology for cellular therapy under development by its subsidiary company, CellExSys.
Columbus Children’s Research Institute (CCRI; www.ccri.net) on the campus of Columbus Children’s Hospital discovers novel approaches to human diseases through research that ranges from basic molecular biology to applied, patient-oriented research. In 2002, the Institute conducted more than 500 research projects. CCRI ranks among the top 10 in National Institutes of Health research awards to free-standing children’s hospitals in the US. CCRI is dedicated to enhancing the health of children and their families locally, nationally and globally.