SOURCE: Targeted Genetics

August 21, 2007 04:30 ET

Targeted Genetics Reports Interim Phase II Data From HIV/AIDS Vaccine Clinical Trial

SEATTLE, WA--(Marketwire - August 21, 2007) - Targeted Genetics Corporation (NASDAQ: TGEN) presented interim data this week from a Phase II trial of tgAAC09 in Africa. 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. Consistent with previous clinical experience with tgAAC09, the results reported today demonstrate that in this study the vaccine candidate was safe and well tolerated. Modest immune responses were shown in some recipients who received higher doses of rgAAC09. Targeted Genetics, the International AIDS Vaccine Initiative (IAVI), researchers at Columbus Children's Research Center and Children's Hospital of Philadelphia have collaborated on the development of tgAAC09 and other AAV-based HIV vaccines.

In this double-blind, randomized, placebo-controlled study, 91 healthy HIV-negative volunteers at five clinical sites in Africa have received two intra-muscular injections of placebo or tgAAC09 at 3 different dosage levels either six or 12 months apart. The reported safety data reflect results following the first vaccination and re-vaccination in 91 and 82 volunteers, respectively. To date, the vaccine has been well tolerated, and no severe local or systemic reactions to vaccination have been reported.

Africa has been hardest hit by the HIV/AIDS pandemic. These data reinforce the Company's clinical experience to date with tgAAC09, demonstrating safety and tolerability.

Immunogenic data indicate modest, dose dependent immunogenicity, with responses being directed mostly to gag. Presence of neutralizing titers to AAV2 at baseline does not appear to impact response to vaccination.

Targeted Genetics' future development plans for this program include the evaluation of vaccine candidates containing several additional HIV-1 genes, either alone or in a prime-boost strategy.

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 Europe 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 was conducted in collaboration with researchers at Columbus Children's Research Institute and The Children's Hospital of Philadelphia.

This current phase II trial of a vaccine based on AAV2 is being conducted in Africa 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 that encode proteins to increase gene function or RNAi to decrease or silence gene function. Targeted Genetics' product development efforts target inflammatory arthritis, AIDS prophylaxis, congestive heart failure and Huntington's disease. To learn more about Targeted Genetics, visit Targeted Genetics' website at www.targetedgenetics.com.

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

This release contains forward-looking statements regarding the data to be collected in this trial, the establishment or determination of efficacy endpoints from the data collected in the trial, the timely and complete accrual of patients in the trial and our ability to commercialize 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, our ability to obtain, maintain and protect our intellectual property, our ability to raise capital when needed, our ability to recruit and enroll suitable trial participants, the timing, nature and results of research and clinical trials, potential development of alternative technologies or more effective processes by competitors, and, our ability to obtain and maintain regulatory or institutional approvals, as well as other risk factors described in Item 1A. Risk Factors in our report on Form 10-K for the year ended December 31, 2006 and updated in Item 1A. Risk Factors in our Form 10-Q for the quarter ended June 30, 2007. 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.

Contact Information

  • Investor and Media Contact:
    Stacie D. Byars
    Director, Communications
    Targeted Genetics Corporation
    (206) 521-7392