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 who have failed previous therapy with bacillus calmette-guerin (BCG), the current standard therapy for recurrent bladder cancer.
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.
CG0070 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 which is also a key component in Cell Genesys’ lead product platform, GVAX cancer immunotherapies. As a result, CG0070 can potentially destroy cancer cells by two different mechanisms: direct cell killing by the virus and immune-mediated cell killing stimulated by GM-CSF.
“We are optimistic that the dual mechanism of action of CG0070 might result in enhanced local anti-tumor activity as well as potential systemic anti-tumor immunity following local administration,” stated Dr Joseph Vallner, president and COO of Cell Genesys.