"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.

Targeted Genetics Corp., the not-for-profit International AIDS Vaccine Initiative (IAVI), the Indian Council of Medical Research (ICMR) and National AIDS Control Organization (NACO), along with researchers at Columbus Children's Research Institute (CCRI) and The Children's Hospital of Philadelphia (CHOP), on Monday announced the initiation of the Phase I trial in India.

Tests in a Variety of Settings

"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."

European Trial Results Expected Soon

The Phase I clinical trial is a double-blind, placebo-controlled, dose-escalating safety study that also will 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.