A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin
18 Years and older, Male and Female
This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.
BC-819 (inodiftagene vixteplasmid) is a recombinant DNA plasmid that directs the expression
of a potent toxin specifically in malignant cells but not in normal tissue. It has been
designed to exploit the established biology of the H19 gene, which is upregulated and
expressed at high levels only in malignant cells, to produce bacterial diphtheria toxin only
in bladder cancer tissue. BC-819 is administered directly into the bladder to enable maximal
topical exposure to target bladder cancer cells.