TGEN Tecogen Inc

Targeted Genetics Presents Rheumatoid Arthritis Program Overview at the International Meeting on Gene Therapy in Rheumatology and Orthopaedics Preclinical Results Support Phase I Clinical Trial Currently Underway SEATTLE, May 21 /PRNewswire-FirstCall/ -- Targeted Genetics Corporation will present an overview of its rheumatoid arthritis clinical program today at the 3rd International Meeting on Gene Therapy in Rheumatology and Orthopaedics in Boston, MA. Haim Burstein, Ph.D., senior director of product discovery at Targeted Genetics, will deliver an oral presentation during the session titled, "Clinical Trials." Targeted Genetics' product candidate to treat rheumatoid arthritis, tgAAC94, utilizes the Company's recombinant adeno-associated vector (rAAV) technology platform to deliver the DNA sequence encoding a potent inhibitor of tumor necrosis factor (TNF-alpha), known as TNFR:Fc, directly into affected joints of patients suffering from rheumatoid arthritis. Dr. Burstein's presentation will include a product overview, encouraging preclinical results testing both tgAAC94 and a homologous vector, tgAAV-ratTNFR:Fc, for testing in rats, and current clinical program status. Important preclinical results to be highlighted in the presentation include: -- No safety issues attributable to tgAAC94 or tgAAV-ratTNFR:Fc in all preclinical studies conducted; -- Administration of tgAAV-ratTNFR:Fc resulted in suppression of arthritis as measured by decreases in articular index score; and -- Local TNFR:Fc expression was confirmed in the injected joint after local administration of tgAAV-ratTNFR:Fc in both normal and arthritic rats without significant systemic TNFR:Fc protein levels. "Preclinical studies conducted in support of Targeted Genetics' current Phase I clinical trial consistently demonstrated both safety and suppression of arthritis in animal models," said Dr. Burstein. "TNF-a has proven to play a pivotal role in the inflammatory cascade that leads to joint damage and destruction associated with rheumatoid arthritis in a patient setting. Our product candidate, tgAAC94, consists of delivery of the gene encoding the TNF-a antagonist TNFR:Fc directly into diseased joints. Preclinical results presented today demonstrate that therapeutic use of the gene results in suppression of arthritis as evidenced by decreased articular index score, inflammatory cell infiltration, pannus formation and cartilage and bone destruction. We look forward to the results of our Phase I clinical trial currently underway, as it is our first opportunity to observe the impact of tgAAC94 in a patient setting." Targeted Genetics' Phase I clinical trial is a multi-center, randomized, double-blind, placebo-controlled, dose escalation study designed to assess safety of intra-articular delivery of tgAAC94. Other secondary parameters assessed are the ability of intra-articular administration of tgAAC94 to reduce pain and swelling in the injected joint and overall disease activity. The amount of local and circulating TNFR:Fc protein also will be measured. The trial is being conducted in the U.S. and Canada, and will ultimately enroll up to 32 patients. Participants will receive a single injection of tgAAC94 or placebo directly into an affected joint and will be followed for 24 weeks following injection. About Targeted Genetics Targeted Genetics Corporation develops gene-based products for preventing and treating acquired and inherited diseases. The Company has three clinical product development programs, targeting cystic fibrosis, AIDS prophylaxis and rheumatoid arthritis. The Company also has a promising pipeline of product candidates focused on hemophilia and cancer and a broad platform of gene delivery technologies, as well as a promising body of technology for cellular therapy under development by its subsidiary company, CellExSys. For more information about the Company visit its website at http://www.targetedgenetics.com/. This release contains forward-looking statements regarding our regulatory filings, research programs, clinical trials, product development and potential related to 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, the timing, nature and results of our research and our clinical trials, our ability to recruit and enroll suitable trial participants, our ability to obtain and maintain regulatory or institutional approvals, our ability to obtain, maintain and protect our intellectual property related to tgAAC94, and our ability to raise capital when needed, as well as other risk factors described in the section entitled "Factors Affecting Our Operating Results, Our Business and Our Stock Price" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2004. 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. DATASOURCE: Targeted Genetics Corporation CONTACT: Courtney Self of Targeted Genetics Corporation, +1-206-521-7392 Web site: http://www.targetedgenetics.com/

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