14.11.2005 18:49:00
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IAVI Begins First Phase II Preventive HIV Vaccine Trial in South Africa to Test Targeted Genetics' HIV Vaccine Candidate
This is the first Phase II HIV vaccine trial to be held in SouthAfrica. Candidate vaccines that are proven to be safe in Phase Itrials move on to Phase II trials, allowing investigators to test theimmune 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 Sowetowith Dr. Eftyhia Vardas as the principal investigator; Desmond TutuInstitute for HIV Research, University of Cape Town, with Dr.Linda-Gail Bekker as the principal investigator; and Medunsa Campus ofthe University of Limpopo with Professor Anwar Hoosen as the principalinvestigator. IAVI also plans to test the vaccine in Zambia andUganda, pending regulatory approval in those countries.
"We are pleased that South Africa has taken a leading role in thetesting of vaccine candidates given the medical and humanitarianpromise a preventive vaccine holds," said Dr. Eftyhia Vardas of thePerinatal HIV Research Unit, who is the national protocol chair of thetrial.
South Africa approved its first HIV vaccine trials in 2003,including one sponsored by IAVI. In 1999, the government created theSouth African AIDS Vaccine Initiative (SAAVI) to coordinate theresearch, development, and the testing of HIV vaccines. SAAVI is thenational 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 ingreatest need will take many more innovative partnerships like thisone given the difficult scientific challenges we face," said SethBerkley, M.D., CEO and President of IAVI. "Preventive vaccines haveended or helped control the most deadly infectious diseases known toman. Finding a vaccine to stop the spread of the HIV virus must be aglobal priority."
"Southern Africa has been devastated by AIDS, and we believe thatevaluating tgAAC09 in this region could potentially advancedevelopment of this promising vaccine candidate while supporting theglobal effort to halt the HIV pandemic," said H. Stewart Parker,President and Chief Executive Officer of Targeted Genetics. "TargetedGenetics and our partners are implementing a multi-faceted clinicaltrials program for tgAAC09 that is designed to generate robust data ina rapid and rigorous manner. We are pleased to be working with IAVIand SAAVI in the fight against HIV/AIDS."
About the Vaccine Candidate
The vaccine candidate, tgAAC09, utilizes a recombinantadeno-associated viral vector (rAAV) that was developed with andmanufactured 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 totest the vaccine. The Phase II trial follows positive safety datareceived from the Phase I trial conducted over the past two years inBelgium, Germany, and India where volunteers received a lower-doserange.
Targeted Genetics' AAV development process is based on a cell linewhich was designed by Philip R. Johnson, MD., at the Children'sResearch Institute on the campus of Children's Hospital, in Columbus,Ohio, USA. Dr. Johnson is now Chief Scientific Officer at theChildren's Hospital of Philadelphia, Pennsylvania, USA.
About the Trial
The trial should take about 18 months to complete and will enroll78 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 vaccineconsists of an artificially made copy of the HIV virus and cannotcause HIV infection or AIDS.
IAVI estimates that there are 30 preventive HIV vaccine candidatesin human trials on six continents.
About IAVI
The International AIDS Vaccine Initiative (IAVI) is a globalnot-for-profit organization working to accelerate the development of avaccine to prevent HIV infection and AIDS. Founded in 1996 andoperational in 23 countries, IAVI and its network of collaboratorsresearch and develop vaccine candidates. IAVI also advocates for avaccine to be a global priority and works to assure that a futurevaccine will be accessible to all who need it. IAVI's financial andin-kind supporters include the Bill & Melinda Gates Foundation, theRockefeller Foundation, Alfred P. Sloan and Starr Foundations; theGovernments of Canada, Denmark, the European Union, Ireland, theNetherlands, Norway, Sweden, the United Kingdom, the United States andthe Basque Country; multilateral organizations such as the World Bank;corporate donors including BD (Becton, Dickinson & Co.), ContinentalAirlines and DHL; leading AIDS charities such as Crusaid, DeutscheAIDS Stiftung, and the Until There's A Cure Foundation; and otherprivate donors such as the Phoebe W. Haas Charitable Trust B. For moreinformation, see www.iavi.org.
About Targeted Genetics
Targeted Genetics Corporation is a biotechnology company committedto the development and commercialization of innovative targetedmolecular therapies for the prevention and treatment of acquired andinherited diseases with significant unmet medical need. We use ourconsiderable knowledge and capabilities in the development andmanufacturing of gene delivery technologies to advance a diverseproduct development pipeline. Our product development efforts targetinflammatory arthritis, AIDS prophylaxis, congestive heart failure,Huntington's disease and hyperlipidemia. To learn more about TargetedGenetics, visit our website at: www.targetedgenetics.com.
Safe Harbor Statement under the Private Securities LitigationReform Act of 1995:
This release contains forward-looking statements regarding ourregulatory filings, research programs, clinical trials, productdevelopment and potential related to tgAAC09. These statements,involve current expectations, forecasts of future events and otherstatements that are not historical facts. Inaccurate assumptions andknown and unknown risks and uncertainties can affect the accuracy offorward-looking statements. Factors that could affect our actualresults include, but are not limited to, our ability to recruit andenroll suitable trial participants, the timing, nature and results ofour research and our clinical trials, our ability to raise capitalwhen needed, our ability to obtain and maintain regulatory orinstitutional approvals, and, our ability to protect our intellectualproperty, as well as other risk factors described in the sectionentitled "Factors Affecting Our Operating Results, Our Business andOur Stock Price" in our Quarterly Report on Form 10-Q for the quarterended September 30, 2005. You should not rely unduly on theseforward-looking statements, which apply only as of the date of thisrelease. We undertake no duty to publicly announce or report revisionsto these statements as new information becomes available that maychange our expectations.
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