SOURCE: Targeted Genetics

March 18, 2008 07:30 ET

Targeted Genetics Announces Completion of Dosing for the Phase 1/2 Clinical Trial of tgAAC94 for Inflammatory Arthritis

Future Trial Designs Underway

SEATTLE, WA--(Marketwire - March 18, 2008) - Targeted Genetics Corporation (NASDAQ: TGEN) today announced that dosing has been completed for the Phase 1/2 clinical trial of tgAAC94 for the treatment of inflammatory arthritis.

"We are very pleased that there is continued commitment among patients to complete this important study. We believe it is critical that we let the clinical trial and scientific process determine the risks and benefits of gene therapy," said H. Stewart Parker, president and chief executive officer of Targeted Genetics. "Inflammatory arthritis is a serious disease affecting more than two million people in the United States alone that can lead to debilitating chronic pain, permanent nerve, bone and joint damage, and, in some cases, death. While systemic medications are available to slow and sometimes stop symptoms, they can compromise the immune system and leave patients with side effects, such as chronic infections. Our targeted therapy candidate is designed to reduce inflammation locally in the joints and avoid the potential for systemic side effects. We believe tgAAC94 has the potential to improve the treatment of this serious disease."

The Company reported interim data from this ongoing Phase 1/2 clinical trial of our inflammatory arthritis candidate at the American College of Rheumatology (ACR) meeting. The data indicate that tgAAC94 is well-tolerated at the highest dose tested in the trial and demonstrate that a higher percentage of subjects who received tgAAC94 showed improvement in function and pain compared to results from the placebo injected group.

The Company plans to report additional Phase 1/2 results during 2008 at the American Society of Gene Therapy (ASGT), the European League Against Rheumatism (EULAR) and ACR in May, June and November respectively.

Additional protocols are currently being developed to evaluate efficacy and duration of response, as well as to further assess safety, in patients with inflammatory arthritis who have one or few inflamed joints and are not candidates for systemic therapy or do not fully respond to systemic anti-TNF protein therapy.

Phase 1/2 Study Details

The ongoing Phase 1/2 study is designed to assess the safety and potential efficacy of different doses of tgAAC94 administered directly to affected joints of subjects with inflammatory arthritis. Subjects already enrolled in the study will continue to be followed and monitored. Since the trial began in October 2005, 127 subjects have been enrolled in the study. In July 2007, this study was placed on clinical hold when a patient who was participating in the study experienced a serious adverse event, or SAE, and subsequently died. An independent and in-depth review of all available product and clinical data was conducted to determine whether tgAAC94 contributed in any way in this patient's death. Evidence found and presented at the September and December 2007 meetings of the National Institutes of Health Recombinant DNA Advisory Committee supported the position that tgAAC94 did not contribute to nor cause the patient's death. The committee determined that the patient died of an invasive fungal infection, and in November 2007, the U.S. Food and Drug Administration removed the hold on the study.

About tgAAC94

tgAAC94 is being developed as a supplemental therapeutic to systemic anti-TNF-alpha protein therapy for use in patients with inflammatory arthritis who have one or few inflamed joints or who do not fully respond to systemic protein therapy. The product candidate uses Targeted Genetics' recombinant AAV (rAAV) vector technology to deliver a DNA sequence that encodes a soluble form of the TNF-alpha receptor (TNFR: Fc). Soluble TNFR:Fc inhibits the immune stimulating activity of TNF-alpha. Direct injection of tgAAC94 into affected joints leads to the localized production of secreted TNFR:Fc within joint cells, reducing the activity of TNF-alpha within the joint and, potentially, leading to a decrease in the signs and symptoms of inflammatory disease and inhibition of joint destruction.

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 continuation and results of its clinical trial of tgACC94, the data collected in the tgAAC94 program, the cause of the serious adverse event, establishment or determination of efficacy endpoints from the data collected in the trial, and the timely and complete accrual of patients in the trial. 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 actual future events or results include, but are not limited to, the timing, nature and results of the Company's clinical trials, the Company's ability to obtain and maintain regulatory or institutional approvals, and the Company's ability to obtain, maintain and protect its intellectual property, as well as other risk factors described in "Item 1A. Risk Factors" in the Company's most recent annual report on Form 10-K for the year ended December 31, 2006 filed with the SEC and in its most recently filed quarterly report on Form 10-Q for the quarter ended September 30, 2007. You should not rely unduly on these forward-looking statements, which apply only as of the date of this release. The Company undertakes no duty to publicly announce or report revisions to these statements as new information becomes available that may change the Company's expectations.

Contact Information

  • Investor and Media Contacts:
    Stacie D. Byars
    WeissComm Partners for
    Targeted Genetics Corporation
    Office: 415.946.1072
    Mobile: 206.660.2588
    Email Contact

    Carolyn Wang
    WeissComm Partners
    Office: 415.946.1065
    Email Contact