TGEN Tecogen Inc

Targeted Genetics Presents at 18th Annual North American Cystic Fibrosis Conference Independent Safety Reviews of Phase II Cystic Fibrosis Trial Remain Positive; Results Expected in First Half of 2005 SEATTLE, Oct. 15 /PRNewswire-FirstCall/ -- Targeted Genetics Corporation (NASDAQ:TGEN) today presented a safety summary of its ongoing Phase II cystic fibrosis (CF) clinical trial of its product candidate tgAAVCF. Today's poster presentation included an overview of clinical trial design, safety data on subjects treated thus far, and conclusions of an interim analysis. Results from an independent data monitoring committee (DMC) indicate that planned safety reviews have yielded no safety concerns thus far. In addition, a planned interim analysis, held in June 2004 by the DMC, resulted in the recommendation to continue the study. Trial data remain blinded to the Company, study investigators and participants. This poster was presented at the 18th Annual North American Cystic Fibrosis Conference in St. Louis, MO by Richard B. Moss, M.D., Pediatric Pulmonary Medicine, Stanford University Medical Center and lead clinical investigator in this study. "Ongoing independent safety analyses of our Phase II CF clinical trial continue to demonstrate a good safety profile for tgAAVCF, and we are pleased to report that study enrollment remains on target for completion by the end of 2004," said Dr. Moss. "tgAAVCF represents a whole new way of treating CF. It targets the root cause of disease, with the potential to delay the progression of CF. This would have a meaningful impact on patients who suffer from this chronic disease. Results from previous clinical trials have been encouraging, and we eagerly anticipate data from this study, representing the largest CF gene therapy trial to date." Based upon its June 2004 review, the DMC recommended continuation of the study as planned. The DMC provided its recommendation based on an analysis of whether or not there was a chance that, upon full patient enrollment, the study could show a statistically significant 30-day change in lung function in patients treated with tgAAVCF compared to placebo. The DMC has additionally conducted three interim safety analyses thus far as part of a planned independent safety review. Each time no safety concerns were raised, and study continuation was recommended. This Phase II, double-blind, randomized, placebo-controlled study is partially funded by Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the drug discovery and development affiliate of the Cystic Fibrosis Foundation, and is being conducted through CFFT's Therapeutics Development Network. The primary end-point of this trial is 30-day change in lung function after two doses of tgAAVCF. Researchers also are assessing the impact of tgAAVCF on inflammation and biologic markers over time when compared to placebo. The study continues to monitor the safety and tolerability profile of tgAAVCF. A total of 100 patients, 12 years of age and older, are being evaluated, 50 in the treatment group and 50 in the placebo group. Study participants receive two doses of 1x1013 DNAse resistant particles (DRP) of tgAAVCF or placebo, delivered via nebulizer at day 0 and day 30 of the study and are evaluated for change in lung function every two weeks over the course of 90 days. Study participants are being monitored for safety for a total of seven months. 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 for application in nucleic acid-based drug development. For more information about Targeted Genetics, visit its website at http://www.targetedgenetics.com/. This release contains forward-looking statements regarding our research programs, clinical trials, product development and potential related to tgAAVCF 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 patients for our clinical trials in a timely manner, our ability to obtain and maintain regulatory or institutional approvals, our ability to obtain, maintain and protect our intellectual property related to tgAAVCF, 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 June 30, 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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