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ARTICLE | Clinical News

CG0070: SPA received

September 17, 2012 7:00 AM UTC

Cold Genesys said it reached an agreement with FDA on an SPA for the open-label Phase II/III BOND trial to compare intravesical CG0070 administered weekly for 6 weeks vs. the active comparator mitomycin C, interferon, valrubicin or gemcitabine in 210 patients. The trial will enroll patients with non-invasive bladder cancer with carcinoma in situ who have failed bacillus Calmette-Guerin (BCG) therapy and have refused cystectomy. The company plans to start the trial in January. ...