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Data From Targeted Genetics' tgAAC09 Vaccine for AIDS Presented at Conference

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[Moderators note: " In this Phase I study, 80 healthy volunteers in

Europe and India received a single intramuscular injection of tgAAC09

at different doses " .... " The Phase I trial in Germany, Belgium and

India is being conducted in collaboration with researchers at

Columbus Children's Research Institute and The Children's Hospital of

Philadelphia " . Observers of Indian AIDS vaccine trial should not miss the

point. The data collected by ICMR researchers does not even worth for a footnote

or an acknowledgement from the Targeted genetics?]

Phase I Data From Targeted Genetics' tgAAC09 Vaccine for HIV/AIDS

Presented at Scientific Conference.

28 Feb 2007. Announced that Dr. Jan van Lunzen, Medical Director, University

Medical Center, Hamburg Eppendorf, Germany, presented updated Phase I data from

a study of tgAAC09 in healthy volunteers not infected with HIV in a poster

presentation at the 14th Conference on Retroviruses and Opportunistic Infections

in Los Angeles.

SEATTLE, WA, USA | Feb 28, 2007 | Targeted Genetics Corporation

(NASDAQ: TGEN) today announced that Dr. Jan van Lunzen, Medical

Director, University Medical Center, Hamburg Eppendorf, Germany,

presented updated Phase I data from a study of tgAAC09 in healthy

volunteers not infected with HIV in a poster presentation at the 14th

Conference on Retroviruses and Opportunistic Infections in Los

Angeles. The tgAAC09 vaccine candidate utilizes an adeno-associated

virus (AAV) vector to deliver genes encoding HIV proteins and is

designed to stimulate an immune response against HIV.

Targeted Genetics, the International AIDS Vaccine Initiative (IAVI)

and researchers at Columbus Children's Research Center and Children's

Hospital of Philadelphia are collaborating on the development of

tgAAC09 and other AAV-based HIV vaccines.

" The results reported today reinforce the favorable safety and

tolerability profiles of tgAAC09 observed in clinical trials to date,

and provide the rationale for evaluating the vaccine at higher doses

and at different dosing intervals, " said H. , president

and chief executive officer of Targeted Genetics. " We have a Phase II

clinical study of tgAAC09 at higher doses currently underway at

multiple sites in South Africa, Zambia and Uganda, and are continuing

to work with our collaborators to explore additional vaccine

constructs comprising other AAV serotypes and HIV genes. We believe

that AAV-based vaccines may play an important role in mitigating the

global HIV/AIDS pandemic. "

In this Phase I study, 80 healthy volunteers in Europe and India

received a single intramuscular injection of tgAAC09 at different

doses. Additionally, 21 of the 50 European volunteers received a

booster vaccination of either tgAAC09 at the highest dose tested, or

placebo. The results presented today demonstrate that vaccination

with tgAAC09 appears to be safe and well tolerated and stimulated a

modest immune response against gag, the principal HIV protein encoded

by tgAAC09. In animal models, tgAAC09 elicited both T- and B-cell

responses. In this trial, HIV-specific T-cell responses were observed

in 20 percent of participants receiving the highest dose of tgAAC09

tested; however antibody responses were not observed.

" Although the responses in this study are modest overall, it is very

encouraging to see a 20% participant response at this dose

threshold, " said Dr. van Lunzen. " Given the dose-response

relationship observed in this trial, it is our hope that higher doses

may enhance the vigor of the immune response elicited by tgAAC09.

Further study of this and other AAV-based vaccines is warranted, as

they provide a novel approach for using the power of the immune

system to fight such a devastating infection. "

About the tgAAC09 Clinical Program

The Phase I clinical trial is a double-blind, placebo-controlled,

dose-escalation safety study that also monitors immune responses to

HIV antigens. The portion of the study conducted in Belgium and

Germany enrolled 50 volunteers who were in good general health and

not infected with HIV.

The portion of the trial being conducted in India enrolled 30 healthy

HIV-uninfected volunteers. Each volunteer received a single intramuscular

injection into the upper arm. A subset of volunteers also received a second dose

of the vaccine to determine if repeat dosing is safe, and if it boosts immune

responses.

The Phase I trial in Germany, Belgium and India is being conducted in

collaboration with researchers at Columbus Children's Research Institute and The

Children's Hospital of Philadelphia.

A Phase II trial of a vaccine based on AAV2 is being conducted in

collaboration with the Hani Baragwanath Hospital, the Desmond

Tutu Institute for HIV Research and the University of Limpopo in

South Africa; the Uganda Virus Research Institute; and the Zambia

Emory HIV Research Project.

This trial is being conducted in order to evaluate the potential impact of a

higher dose of tgAAC09 and boost vaccination on the strength and duration of

immune responses.

About Targeted Genetics

Targeted Genetics Corporation is a biotechnology company committed to

the development of innovative targeted molecular therapies for the

prevention and treatment of acquired and inherited diseases with

significant unmet medical need. Targeted Genetics' proprietary Adeno-

Associated Virus (AAV) technology platform allows it to deliver genes

encoding proteins to increase gene function, as well as RNAi to

decrease or silence gene function. Targeted Genetics' product

development efforts target inflammatory arthritis, AIDS prophylaxis,

congestive heart failure and Huntington's disease.

www.targetedgenetics.com.

http://www.pipelinereview.com/joomla/content/view/10130/100/

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