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Biotech / Medical : TGEN - Targeted Genetics Corporation -- Ignore unavailable to you. Want to Upgrade?

To: Mike McFarland who wrote (505)	6/4/2007 11:33:25 PM
From: Mike McFarland	Read Replies (1) \| Respond to of 557

Seattle, WA - June 4, 2007 - Targeted Genetics Corporation (Nasdaq: TGEN) today announced additional data from the dose escalation arm of the ongoing Phase I/II clinical study of tgAAC94 in patients with inflammatory arthritis. Philip J. Mease, M.D., clinical professor at the University of Washington School of Medicine, chief of rheumatology clinical research at the Swedish Medical Center, practicing physician with Seattle Rheumatology Associates and the lead investigator on the trial presented the data in an oral presentation yesterday at the 10 th Annual Meeting of the American Society of Gene Therapy in Seattle (ASGT) . Interim aggregate data on the primary and secondary end-points were presented from the first 61 subjects in the dose escalation portion (cohorts 1 to 3) of the Phase I/II clinical trial of tgAAC94 in patients with inflammatory arthritis. Completion of enrollment and initial dosing of all subjects in the second segment (cohorts 4 to 6) of this trial was announced recently. tgAAC94 is an investigational therapeutic designed to inhibit the activity of tumor necrosis factor-alpha (TNF-alpha), a key mediator of inflammation. The Phase I/II study is designed to assess the safety and potential effect of different doses of tgAAC94 administered directly to affected joints of subjects with inflammatory arthritis with or without concurrent use of systemic TNF antagonist therapies. H. Stewart Parker, president and chief executive officer of Targeted Genetics said, “The rapid enrollment in this study, which was completed last month, underscores the need for additional treatments for inflammatory arthritis. We believe that tgAAC94 has significant potential to address disease that remains refractory to approved therapies, and are encouraged by the data suggesting that tgAAC94 can reduce signs and symptoms of inflammatory arthritis.” In the dose escalation portion of the study, three cohorts of 20 subjects were randomized to receive tgAAC94 (n = 15) or placebo (n = 5). Aggregate data on the primary and secondary end-points from the first 61 subjects support the safety and tolerability of 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 volume in subjects with and without systemic TNF-alpha antagonists. Transient injection administration site reactions consisting of mild to moderate increases in joint tenderness and swelling were noted in 10% of the subjects overall. At week 12 after treatment with tgAAC94, 13%, 14% and 33% of subjects receiving low, mid and high dose tgAAC94, respectively, achieved a two-point reduction in swelling compared to none in the placebo group. A trend in reduction of swelling in tgAAC94-injected joints compared to placebo was also observed in subjects with or without concurrent use of systemic TNF antagonist. For each of the cohorts, all subjects receive a dose of tgAAC94 at 12 weeks or later after first injection. The criteria for timing of the second injection are: no improvement in swelling 12 weeks after first injection; swelling returns to baseline levels after an initial improvement 12 or more weeks after first injection; or more than 30 weeks have passed since first injection. According to these criteria, a similar proportion of subjects did not need the second injection prior to week 30 in all dose groups and placebo. Following the second injection, subjects are followed for an additional 30 weeks. “These results suggest that tgAAC94 has the potential to improve disease symptoms that are refractory to other therapies, including systemic TNF antagonists,” said Dr. Mease. “Data from the remaining cohorts and longer-term follow up of all study subjects should provide important insight into the role that tgAAC94 may play in the treatment of inflammatory arthritis. Additional treatment options are essential for allowing all patients with inflammatory arthritis to achieve optimal relief of their symptoms.” Patients randomized in the second segment (cohorts 4 to 6) of this Phase I/II study are currently being followed for safety and improvement in swelling of injected joints as well as additional measures aimed to assess functional improvement in treated joints. MRI will also be performed on treated joints in a subset of subjects. Data from cohorts in the Phase II segment are anticipated to provide additional insight into clinical observations and duration of response, as well as correlate clinical observations with image-based assessments of disease severity and response to tgAAC94. These data will guide further clinical development and design of the subsequent Phase II study. The company expects to present additional data from the study in the second half of 2007, with complete results anticipated in mid-2008.