The trial will be conducted at the Uganda Virus Research Institute (UVRI) in
Entebbe, Uganda with Dr. Pontiano Kaleebu acting as the Principal Investigator.
Parallel trials are currently underway at three sites in South Africa. There are
also plans to evaluate the vaccine candidate 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 candidate 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 advances the 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 of an effective vaccine," 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 is designed to enroll a total of 78
volunteers at five sites. Its primary objective 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 infection. 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.
About IAVI
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. For more information, see www.iavi.org.
About UVRI
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, HIV/AIDS and other
acquired and inherited diseases with significant unmet medical need. We use our
considerable knowledge and capabilities in the development and manufacture 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.
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