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Biotech / Medical : TGEN - Targeted Genetics Corporation -- Ignore unavailable to you. Want to Upgrade?

To: 9wald9 who wrote (412)	6/16/2004 6:22:36 PM
From: 9wald9	Read Replies (1) \| Respond to of 557

Targeted Genetics' AAV Technology Highlighted in Vaccine Symposium at the 7th Annual Meeting of the American Society of Gene Therapy PR Newswire, Monday, June 07, 2004 at 08:00 MINNEAPOLIS, and SEATTLE, Jun 7, 2004 /PRNewswire-FirstCall via COMTEX/ -- Targeted Genetics Corporation (Nasdaq: TGEN) announced that its rAAV (recombinant adeno-associated viral) vector technology was highlighted for its potential utility in the prevention of AIDS at the 7th Annual Meeting of the American Society of Gene Therapy. Philip R. Johnson, MD, president of the Columbus Children's Research Institute (CCRI) presented this topic during a scientific symposium titled,"Gene-Based Vaccines: Clinical Applications of Gene-Based Vaccines and Immunotherapeutics (Biodefense, Vaccines, Cancer)."Dr. Johnson discussed the unique attributes of AAV, and its potential to play a role in preventing disease. He focused on Targeted Genetics' ongoing program utilizing rAAV technology as a vaccine candidate to prevent AIDS. CCRI is one of the collaborative partners participating in Targeted Genetics' rAAV-based AIDS vaccine clinical program. In this clinical program, rAAV vectors are used to deliver select genes from the HIV genome into healthy volunteers in an attempt to elicit immune system responses to prevent AIDS. The current product candidate now in a Phase I clinical trial, tgAAC09, is designed to elicit two different types of immune responses, an antibody response and a cell-mediated response, after a single-shot administration of the product candidate. The International AIDS Vaccine Initiative also is a partner in this collaborative effort."Utilization of rAAV-based gene delivery offers significant strategic advantages, making this technology uniquely qualified to play a role in disease prevention,"said Dr. Johnson."AAV is a small, stable, naturally occurring virus with high level expression capabilities. Preclinical results from our rAAV-based AIDS vaccine program were quite encouraging, and we have now moved our program into clinical development, providing us with the first opportunity to observe results of our rAAV-based vaccine candidate in humans. If proven effective, this may provide the basis for potential use of rAAV in other vaccine settings."During Dr. Johnson's presentation, he reviewed various preclinical results compiled in support of a clinical program testing an rAAV-based vaccine to prevent AIDS. Highlighted preclinical results included: -- No dose-related or clinically significant safety issues; -- Vaccine did not integrate into host chromosome; -- Robust and sustained dose-dependent antibody and antigen-specific T cell responses; and -- Vaccinated animals were protected from disease with statistically significant reduced viral load at peak and set-point. In December 2003, the collaboration initiated a Phase I clinical trial of tgAAC09 as a single-shot AIDS vaccine candidate. The Phase I, dose-escalation clinical trial is a double-blind, placebo-controlled study that will enroll up to 50 volunteers, both men and women, who are uninfected with HIV and in good general health. Each volunteer receives a single intramuscular injection into the upper arm. Following vaccination, study participants will be monitored for safety and evaluated to see if tgAAC09 can elicit an immune response.