February 06, 2006
ENTEBBE, Uganda and Seattle, WA – February 6, 2006 – The Uganda Virus Research Institute (UVRI), the International AIDS Vaccine Initiative (IAVI), and Targeted Genetics Corporation (Nasdaq: TGEN) today announced the start of a Phase II trial in Uganda to test the safety and immunogenicity of tgAAC09, a preventive HIV/AIDS vaccine. This is the second IAVI-sponsored HIV vaccine trial to be conducted in Uganda.
The trial will be conducted at the Uganda Virus Research Institute(UVRI) in Entebbe, Uganda with Dr. Pontiano Kaleebu acting as Principal Investigator. Parallel trials are currently underway at three sites in South Africa. There are also plans to test the vaccine at a fifth site, in Zambia, pending regulatory approval.
“We are pleased that Uganda continues to play a leading role in the testing of promising HIV vaccine candidates,” said Dr. Pontiano Kaleebu. “A vaccine is the world’s best hope to end the spread of a disease that infects 14,000 men, women and children worldwide every day.”
"Developing an AIDS vaccine for the regions of the world in greatest need will take innovative North-South partnerships and a sustained scientific effort." said Seth Berkley, M.D., President and CEO of IAVI. "The development of this vaccine candidate demonstrates the role IAVI plays in bringing together the private sector and public sectors. Uganda provides an excellent scientific environment for HIV vaccine research and clinical trials, a supportive government, and an energized and aware public."
The vaccine candidate was developed by Targeted Genetics Corporation, based in Seattle, Washington, USA. The vaccine is based on HIV subtype C, the subtype of the virus most prevalent in southern and eastern Africa.
The tgAAC09 vaccine is designed as a preventive vaccine, intended to protect people uninfected with HIV from contracting the disease. It is designed to elicit two different types of immune responses, an antibody response and a cell-mediated response.
“Evaluating tgAAC09 in this region could potentially advance development of this promising vaccine candidate and we are pleased to be working in partnership with IAVI and the Uganda government in our fight against HIV/AIDS. This is an example of the kind of international collaboration that is critical to an expedited pursuit to developing an effective vaccine candidate,” said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics. “Our HIV/AIDS vaccine development program is designed to generate robust data in a rapid and rigorous manner, clearly important in support of the global effort to halt the HIV pandemic.”
The study being conducted in Uganda is a small-scale trial. The trial should take about 18 months to complete and will enroll a total of 78 volunteers at five sites. Its primary aim is to test for safety and to gather preliminary data on the ability of the candidate vaccine to stimulate the human immune system to fight HIV/AIDS. It is important to test the vaccine in Africa to see if it is appropriate for use in this region.
Uganda was home to the first ever HIV vaccine trial in Africa in 1999, which was conducted at the Joint Clinical Research Centre. Since that time Uganda has become an important contributor to HIV vaccine research and development in partnership with IAVI and also with the Walter Reed Program and Johns Hopkins University.
About the Vaccine Candidate
The vaccine candidate, tgAAC09, utilizes a recombinant adeno associated viral vector (rAAV) that was developed with and manufactured by Targeted Genetics Corporation, based in Seattle, Washington, USA. Under the terms of a public-private collaboration, IAVI is funding development, pre-clinical, and clinical studies to test the vaccine. The Phase II trial follows positive safety data received from the Phase I trial conducted over the past two years in Belgium, Germany, and India where volunteers received a lower-dose range.
Targeted Genetics’ AAV development process is based on a cell line which was designed by Philip R. Johnson, MD., at the Children’s Research Institute on the campus of Children’s Hospital, in Columbus, Ohio, USA. Dr. Johnson is now Chief Scientific Officer at the Children’s Hospital of Philadelphia, Pennsylvania, USA.
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 23 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI's financial and in kind supporters include the Bill & Melinda Gates Foundation, the New York Community Trust, the Rockefeller Foundation, the Starr Foundation; the Governments of the Basque Country, Canada, Denmark, the European Union, Ireland, the Netherlands, Norway, Sweden, the United Kingdom, and the United States; multilateral organizations such as the World Bank; corporate donors including BD (Becton, Dickinson & Co.), Continental Airlines, DHL and Pfizer; leading AIDS charities such as Broadway Cares/Equity Fights AIDS, Crusaid, Deutsche AIDS Stiftung, and the Until There's A Cure Foundation; and other private donors such as the Haas Charitable Trusts.
The Uganda Virus Research Institute (UVRI),located in Entebbe, Uganda, was established in 1936 as the Yellow Fever Research Institute by the Rockefeller Foundation. In 1950, after gaining regional recognition it was renamed the East African Virus Research institute (EAVRI). After the collapse of the East African Community in 1977, it became a Uganda Government public health research institution and was renamed the Uganda Virus Research Institute. The Government of Uganda now administers and funds the institute through the Uganda National Health Research Organization (UNHRO) which is an umbrella research body within the Uganda Ministry of Health.
The mission of the institute is to carry out scientific research concerning communicable diseases, especially viral diseases of public health importance and to advise the government on strategies for control and prevention. The institute also plays a large role in coordinating and administering virology related clinical trials within the county. Most recently the institute has been involved in human HIV vaccine clinical trials. The HIV/AIDS Reference and Quality Assurance Laboratory (HRL), which is part of the institute plays an important role in making public policy recommendations to the Uganda National Drug Authority on the access and usage of new drugs and medical technologies. The role of the Uganda National Drug Authority is similar to that of the FDA in the United States.
The institute was the first to isolate more than 20 new arboviruses, including West Nile Virus, Bwamba Fever, Semliki Forest Virus, Orungo, Kadam, and O'nyong'nyong.
About Targeted Genetics
Targeted Genetics Corporation is a biotechnology company committed to the development and commercialization of innovative targeted molecular therapies for the prevention and treatment of inflammatory arthritis and other acquired and inherited diseases with significant unmet medical need. We use our considerable knowledge and capabilities in the development and manufacturing of gene delivery technologies to advance a diverse product development pipeline. Our product development efforts target inflammatory arthritis, AIDS prophylaxis, congestive heart failure, Huntington’s disease and hyperlipidemia. To learn more about Targeted Genetics, visit its website at www.targetedgenetics.com.
Targeted Genetics' Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements regarding Targeted Genetics' regulatory filings, research programs, clinical trials, product development and potential related to tgAAC09. These statements, involve current expectations, forecasts of future events and other statements that are not historical facts. Inaccurate assumptions and known and unknown risks and uncertainties can affect the accuracy of forward-looking statements. Factors that could affect Targeted Genetics' actual results include, but are not limited to, the ability to recruit and enroll suitable trial participants, the timing, nature and results of Targeted Genetics' research and clinical trials, Targeted Genetics' ability to raise capital when needed, Targeted Genetics' ability to obtain and maintain regulatory or institutional approvals, and, Targeted Genetics' ability to protect our intellectual property, as well as other risk factors described in the section entitled "Factors Affecting Our Operating Results, Our Business and Our Stock Price" in Targeted Genetics' Quarterly Report on Form 10-Q for the quarter ended September 30, 2005. You should not rely unduly on these forward-looking statements, which apply only as of the date of this release. We undertake no duty to publicly announce or report revisions to these statements as new information becomes available that may change Targeted Genetics' expectations.