The company discontinued its Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in bladder cancer.
Anchiano Therapeutics (NASDAQ:ANCN) has announced it has discontinued its Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC).
As quoted in the press release:
After a thorough analysis of the data, Anchiano determined that there is a low probability of surpassing the pre-defined futility threshold at the planned interim analysis, which required 10 complete responses in 35 patients. The data also indicate a low probability of achieving an efficacy profile that in the company’s estimation would be necessary to support regulatory approval.
As of November 14, 2019, 16 patients were evaluable after the first disease assessment on treatment; of these, three (3/16, 19%) have experienced a complete response. The safety data on the investigational product were consistent with those observed in prior trials. Anchiano has taken steps to notify study investigators that enrollment and further treatment of patients on trial should stop immediately and will work to close the study in the coming weeks.
“We are disappointed by the results of the Codex study, as we recognize the urgent need for new effective therapies for patients with non-muscle-invasive bladder cancer. We thank the patients, caregivers and investigators involved in our clinical study,” said Frank Haluska M.D., Ph.D., President and Chief Executive Officer of Anchiano.