Full Press Release Details
IAVI Begins First Phase II Preventive HIV Vaccine Trial in South Africa to
Test Targeted Genetics HIV Vaccine Candidate
Seattle, WA and New York, NY November 14, 2005 Targeted Genetics Corporation (NASDAQ:
TGEN) and The International AIDS Vaccine Initiative (IAVI) today announced the start of a Phase II
trial in South Africa to test the safety and immunogenicity of tgAAC09, a preventive HIV vaccine
candidate that is based on HIV subtype C, the subtype of the virus most prevalent in southern and
This is the first Phase II HIV vaccine trial to be held in South Africa. Candidate vaccines that
are proven to be safe in Phase I trials move on to Phase II trials, allowing investigators to test
the immune response and acquire more data on safety.
The trial will be conducted in three sites in South Africa: Perinatal HIV Research Unit, Chris Hani
Baragwanath Hospital in Soweto with Dr. Eftyhia Vardas as the principal investigator; Desmond Tutu
Institute for HIV Research, University of Cape Town, with Dr. Linda-Gail Bekker as the principal
investigator; and Medunsa Campus of the University of Limpopo with Professor Anwar Hoosen as the
principal investigator. IAVI also plans to test the vaccine in Zambia and Uganda, pending
regulatory approval in those countries.
We are pleased that South Africa has taken a leading role in the testing of vaccine candidates
given the medical and humanitarian promise a preventive vaccine holds, said Dr. Eftyhia Vardas of
the Perinatal HIV Research Unit, who is the national protocol chair of the trial.
South Africa approved its first HIV vaccine trials in 2003, including one sponsored by IAVI. In
1999, the government created the South African AIDS Vaccine Initiative (SAAVI) to coordinate the
research, development, and the testing of HIV vaccines. SAAVI is the national coordinating body for
vaccine research in South Africa, working with both national and international partners.
Developing an AIDS vaccine for the regions of the world in greatest need will take many more
innovative partnerships like this one given the difficult scientific challenges we face, said Seth
Berkley, M.D., CEO and President of IAVI. Preventive vaccines have ended or helped control
most deadly infectious diseases known to man. Finding a vaccine to stop the spread of the HIV virus
must be a global priority.
Southern Africa has been devastated by AIDS, and we believe that evaluating tgAAC09 in this region
could potentially advance development of this promising vaccine candidate while supporting the
global effort to halt the HIV pandemic, said H. Stewart Parker, President and Chief Executive
Officer of Targeted Genetics. Targeted Genetics and our partners are implementing a multi-faceted
clinical trials program for tgAAC09 that is designed to generate robust data in a rapid and
rigorous manner. We are pleased to be working with IAVI and SAAVI in the fight against HIV/AIDS.
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 trial should take about 18 months to complete and will enroll 78 volunteers in total men and
women who are in good health. tgAAC09 is designed to elicit two different types of immune
responses, an antibody response and a cell mediated response. The vaccine consists of an
artificially made copy of the HIV virus and cannot cause HIV infection or AIDS.
IAVI estimates that there are 30 preventive HIV vaccine candidates in human trials on six
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 assure 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 Rockefeller Foundation, Alfred P. Sloan and Starr
Foundations; the Governments of Canada, Denmark, the European Union, Ireland, the Netherlands,
Norway, Sweden, the United Kingdom, the United States and the Basque Country; multilateral
organizations such as the World Bank; corporate donors including BD (Becton, Dickinson Co.),
Continental Airlines and DHL; leading AIDS charities such as
Crusaid, Deutsche AIDS Stiftung, and
the Until There s A Cure Foundation; and other private
donors such as the Phoebe W. Haas Charitable Trust B. For more
information, see www.iavi.org.
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
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 our website at:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements regarding our 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 our actual results include,
but are not limited to, our ability to recruit and enroll suitable trial participants, the timing,
nature and results of our research and our clinical trials, our ability to raise capital when
needed, our ability to obtain and maintain regulatory or institutional approvals, and, our 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 our
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 our expectations.
Investor and Media Contacts:
Stacie D. Byars, Targeted Genetics, Seattle, 206 521 7392 stacie.byars@targen.com
Gracelle Gerber IAVI, Johannesburg, 27 11 504 4001/ 27 83 272 6373 gracelle@bairds.co.za
Ellena Friedman, IAVI, New York, 212 847 1090/ 646 755 1973 efriedman@iavi.org