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Targeted Genetics, IAVI and Collaborators Expand Phase I Clinical Trial Program of HIV/AIDS Vaccine Program to India


SEATTLE, Feb. 7 /PRNewswire-FirstCall/ -- Targeted Genetics Corp. (Nasdaq: TGEN), the not-for-profit International AIDS Vaccine Initiative (IAVI), the Indian Council of Medical Research (ICMR) and National AIDS Control Organization (NACO), and researchers at Columbus Children's Research Institute (CCRI) and The Children's Hospital of Philadelphia (CHOP) today announced the initiation of a Phase I trial in India of tgAAC09, an investigational recombinant adeno-associated viral vector (rAAV)-based HIV/AIDS vaccine candidate. The trial in India is part of a multi-country Phase I clinical development program for tgAAC09 that is also underway in Germany and Belgium.

"The initiation of this trial is part of our comprehensive strategy to evaluate AAV-based HIV/AIDS vaccine candidates in a variety of settings," said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics. "We believe that this vaccine approach can contribute to addressing the global HIV/AIDS pandemic, and we are conducting studies that will help us to optimize a vaccine candidate that is safe and immunogenic with regard to anti-HIV immune responses. HIV/AIDS is a significant and growing health problem in India, as it is in many other parts of the world, and we are pleased to be collaborating with IAVI and the Indian Government in studying tgAAC09 in a region where development of an effective vaccine is essential."

The Phase I clinical trial is a double-blind, placebo-controlled, dose-escalating safety study that will also monitor immune responses to the product candidate. The study in India is designed to enroll up to 30 volunteers who are HIV uninfected and in good general health. Each volunteer will receive a single intramuscular injection into the upper arm. Data from this study, in combination with data generated by the ongoing Phase I trial in Europe will help to guide future development of this vaccine candidate. Targeted Genetics expects to report data from the European trial in the first half of 2005.

Preclinical studies of tgAAC09 demonstrate that the vaccine induces anti-HIV T-cell and B-cell responses in animal models. Other promising areas of development identified through preclinical studies include the potential to "boost" the effect of the vaccine by administering two sequential doses and the potential utility of vectors derived from AAV serotype 1. Additional studies designed to evaluate these findings in the context of tgAAC09 product development efforts are ongoing.

About Targeted Genetics

Targeted Genetics Corporation develops gene-based products for preventing and treating acquired and inherited diseases. The Company has three clinical product development programs, targeting cystic fibrosis, AIDS prophylaxis and inflammatory arthritis. The Company also has a promising pipeline of product candidates focused on hemophilia and cancer, and a broad platform of gene delivery technologies for application in nucleic acid-based drug development. For more information about Targeted Genetics, visit its website at

Contact: Stephanie Seiler, Ph.D. - 206-713-0124

About IAVI

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, Rockefeller, Alfred P. Sloan and Starr foundations; the governments of Canada, Denmark, Ireland, the Netherlands, Norway, Sweden, the United Kingdom and the United States; multilateral organizations including the European Union and the World Bank; corporations such as 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.

Contact: Ellena Friedman - 212-847-1090

About CCRI

Columbus Children's Research Institute (CCRI; on the campus of Columbus Children's Hospital discovers novel approaches to human diseases through research that ranges from basic molecular biology to applied, patient-oriented research. In 2002, the Institute conducted more than 500 research projects. CCRI ranks among the top 10 in National Institutes of Health research awards to free-standing children's hospitals in the US. CCRI is dedicated to enhancing the health of children and their families locally, nationally and globally.

Contact: Pam Barber - 614-722-4595

About CHOP

The Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking second in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 430-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit

Contact: Peggy Flynn - 267-426-6080

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements regarding our research programs, clinical trials, product development and potential related to tgAAC09 and other statements about our plans, objectives, intentions and expectations. 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, the timing, nature and results of our research and our clinical trials, our preclinical results with animals are not necessarily indicative of results that will be obtained in humans, our ability to obtain and maintain regulatory or institutional approvals, our ability to obtain, maintain and protect our intellectual property related to tgAA09, and our ability to raise capital when needed, 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, 2004. 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.

SOURCE Targeted Genetics Corporation

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Information in this article was accurate in February 7, 2005. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.