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www.fdanews.com/articles/61119-cell-genesys-begins-expanded-trial-of-bladder-cancer-drug

CELL GENESYS BEGINS EXPANDED TRIAL OF BLADDER CANCER DRUG

July 24, 2006

Cell Genesys announced that enrolment has been opened for an expanded, multicenter Phase I clinical trial of CG0070, to evaluate escalating multiple-dose regimens of CG0070 in patients with recurrent bladder cancer.

The expanded trial was prompted by encouraging interim safety and efficacy data, recently reported for single-dose administration of CG0070, and will include up to 45 additional patients.

CG0070, an oncolytic virus therapy that is being developed through a global alliance with Novartis, has been shown to destroy cancer cells of multiple types in numerous preclinical studies. The drug is the first "armed" oncolytic adenovirus therapy to enter clinical development, so-named because it has been engineered to include the therapeutic gene for GM-CSF, an immune-stimulating hormone.

The open-label trial is evaluating intravesical (into the bladder) administration of CG0070 in patients with superficial bladder cancer who have failed previous therapy with Bacillus Calmette-Guerin (BCG), the current standard therapy for recurrent bladder cancer.