SOURCE: Targeted Genetics

February 12, 2007 07:30 ET

Targeted Genetics Provides Inflammatory Arthritis Clinical Trial Update

Results Continue to Show Evidence for Sustained Improvement in Signs and Symptoms of Disease

SEATTLE, WA -- (MARKET WIRE) -- February 12, 2007 -- Targeted Genetics Corporation (NASDAQ: TGEN) provides an update today on its ongoing Phase I/II trial of tgAAC94 in patients with inflammatory arthritis. tgAAC94 is an investigational therapeutic designed to inhibit the activity of tumor necrosis factor-alpha (TNF-alpha), a key mediator of inflammation. The data reported today support the safety and tolerability of a single and repeat intra-articular injections of tgAAC94 to affected joints at doses up to 1x10(13) DNase Resistant Particles per milli-liter (DRP/mL) of joint fluid in subjects with and without systemic TNF-alpha antagonists. The data also continue to suggest that treatment with tgAAC94 may lead to improvements in signs and symptoms of arthritis in injected joints.

Interim analysis of the first three cohorts (n=61) indicate reduction of tenderness and swelling of the injected joint after tgAAC94 administration. The subjects, approximately half of whom were on systemic TNF-alpha antagonists, received an injection of blinded study drug into the knee, ankle, wrist, MCP or elbow. Thirty-nine subjects have received a second injection of open-label tgAAC94. Enrollment is ongoing and the effect of treatment and its duration continues to be evaluated.


As previously presented at the American College of Rheumatology Annual Scientific meeting in November 2006, among the first 41 subjects randomized to the two lower doses of tgAAC94 or placebo, 7 of 10 subjects (70%) who received placebo qualified for open label tgAAC94 prior to 30 weeks, in contrast to 16 of 31 subjects (52%) who received tgAAC94. The median time to second injection was 120, 129 and 145 days for subjects who received placebo, tgAAC94 1x10(11) DRP/mL and tgAAC94 1x10(12) DRP/mL, respectively.

"The data evaluated thus far are encouraging and we are very pleased that positive treatment response trends continue," said H. Stewart Parker, President and CEO of Targeted Genetics. "We are currently on track to complete enrollment of all 120 subjects in the study in the next few months, and plan to present additional interim data at multiple scientific venues during 2007."

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. 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 tgAAC94 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, 2005 and updated in Item 1A. Risk Factors in our Form 10-Q for the quarter ended September 30, 2006. 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