Zambia Begins First Preventive HIV Vaccine Trial
26 4월 2006 - 8:30PM
Business Wire
The Zambia Emory HIV Research Project (ZEHRP), the International
AIDS Vaccine Initiative (IAVI) and Targeted Genetics Corporation
(Nasdaq: TGEN) today announced the initiation of a clinical trial
in Zambia to test the safety and immunogenicity of tgAAC09, a
preventive HIV vaccine. This is the first preventive HIV vaccine
trial to be conducted in Zambia, and will take place at the Zambia
Emory HIV Research Project Center in Lusaka with Dr. Elwyn Chomba
acting as the Principal Investigator. It is an early-stage,
multi-national trial, also being conducted at three sites in South
Africa and Uganda. "Zambia is proud today to be among the leading
countries in Africa to spearhead the testing of vaccine candidates,
given their great potential for the prevention of HIV/AIDS," said
Dr. Elwyn Chomba, ZEHRP and Principal Investigator for the trial.
"IAVI is pleased to be working with the excellent team at ZEHRP.
Supported by the government of Zambia, and in collaboration with
the scientific and medical community in Lusaka, the Zambia Emory
HIV Research Project has contributed to HIV/AIDS prevention in the
country," said Seth Berkley, President and CEO of IAVI. "The Zambia
study, along with other vaccine trials worldwide, will help us all
take the field one step further in our search for a preventive HIV
vaccine." The vaccine candidate, tgAAC09, was developed by Targeted
Genetics, based in Seattle. The vaccine is based on HIV subtype C,
the subtype of the virus most prevalent in southern Africa. tgAAC09
is designed as a preventive vaccine, intended to protect people not
infected 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. "Expanding the evaluation of
tgAAC09 to another region in need further advances the development
of this vaccine candidate. We continue to be optimistic about the
potential of AAV-based vaccines in the fight against HIV/AIDS and
are pleased to be working in partnership with IAVI and ZEHRP in
support of the global effort to halt the HIV pandemic. This is
another 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. About the Vaccine Candidate The vaccine candidate,
tgAAC09, utilizes a recombinant adeno-associated viral vector (AAV)
that was developed with and manufactured by Targeted Genetics.
Under the terms of a public-private collaboration, IAVI is funding
development, pre-clinical and clinical studies to test the vaccine.
The early-stage 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
the Trial The trial should take about 18 months to complete. At the
Lusaka clinical trial site, 16 volunteers (men and women) who are
in good health will be enrolled. IAVI estimates that there are 30
preventive HIV vaccine candidates in human trials on six
continents. About IAVI The International AIDS Vaccine Initiative
(IAVI) is a global not-for-profit organization working to
accelerate the development of a vaccine to prevent HIV infection
and AIDS. Founded in 1996 and operational in 23 countries, IAVI and
its network of collaborators research and develop vaccine
candidates. IAVI also advocates for a vaccine to be a global
priority and works to ensure that a future vaccine will be
accessible to all who need it. 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;
other private donors such as the Haas Charitable Trusts; and many
generous individuals from around the world. For more information,
see www.iavi.org. About ZEHRP The Zambia Emory HIV Research Project
(ZEHRP), located in Lusaka, Zambia. The ZEHRP Ndola and Kitwe sites
located in the Copperbelt and their sister project, Project San
Francisco (PSF), located in Kigali, Rwanda, comprise the Rwanda
Zambia HIV Research Group (RZHRG). The organization works with
couples and has ongoing studies to 1) promote couples voluntary
counseling and testing (CVCT), 2) measure the transmission between
discordant (one HIV-positive and one HIV-negative) couples
(Heterosexual Transmission study) and 3) assess the contraceptive
choices of women (Family Planning study). The RZHRG sites are also
currently participating in a multi-site Phase III clinical trial
assessing the effect of Acyclovir in lowering the transmission of
HIV in discordant couples. The Lusaka site was established in 1994
when Project San Francisco relocated to Zambia during the Rwandan
genocide. ZEHRP boasts three CVCT centres as well as a
well-equipped immunology and clinical laboratory. About Targeted
Genetics Targeted Genetics Corporation (Nasdaq: TGEN) 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. Targeted Genetics uses its considerable knowledge and
capabilities in the development and manufacturing of gene delivery
technologies to advance a diverse product development pipeline. Its
product development efforts target inflammatory arthritis,
HIV/AIDS, congestive heart failure, Huntington's disease and
hyperlipidemia. To learn more about Targeted Genetics, visit its
website at www.targetedgenetics.com. 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 the 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,
its ability to recruit and enroll suitable trial participants, the
timing, nature and results of Targeted Genetics' research and
clinical trials, the potential development of alternative
technologies or more effective products by Targeted Genetics'
competitors, 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 its intellectual property, as well as other risk
factors described in "Item 1A. Risk Factors" in Targeted Genetics'
Annual Report on Form 10-K for the year ended December 31, 2005.
You should not rely unduly on these forward-looking statements,
which apply only as of the date of this release. Targeted Genetics'
undertakes no duty to publicly announce or report revisions to
these statements as new information becomes available that may
change our expectations.
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