CAMBRIDGE, Mass., Dec. 18, 2018 (GLOBE NEWSWIRE) — Anchiano Therapeutics (TASE: ANCN), a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer, today announced the initiation of Codex, the Company’s pivotal Phase 2 study of inodiftagene vixteplasmid (BC-819), a first-in-class gene therapy for patients with non-muscle-invasive bladder cancer (NMIBC). The study will enroll 140 patients with NMIBC whose disease is unresponsive to adequate BCG therapy, as defined by U.S. Food and Drug Administration (FDA) guidance.
“The initiation of the Codex registration trial is a significant milestone for the company,” noted Dr. David Kerstein, Chief Medical Officer of Anchiano Therapeutics. “BCG-unresponsive NMIBC represents an area of high unmet medical need with limited standard treatment options, outside of surgical removal of the bladder. NMIBC is a cancer that has been lacking in new therapies for two decades, and we are excited to embark on this important next step in the development of inodiftagene vixteplasmid.”