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news.Inovio Biomedical has stopped further patient enrollment in its two phase III pivotal studies for its squamous cell head & neck cancer therapy after serious adverse events raised safety concerns.
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The trial, studying the company’s selective electrochemical tumor ablation (SECTA) treatment has been halted on the advice of the independent data monitoring committee (DMC). The committee expressed concern about efficacy and serious adverse events, including higher mortality rates on the SECTA arm of the study than on the surgery arm.
In the DMC’s opinion, based on the totality of the issues, the SECTA arm has an unfavorable benefit-to-risk profile, relative to the surgery arm. The DMC also suggested enrollment difficulties represent a possible challenge to meeting the goals of the trial.
Dr Avtar Dhillon, president and CEO, said: “We are reviewing the DMC’s observations and believe it is prudent to act on their recommendation. We believe the SECTA therapy has notable merits that, from a medical and shareholder perspective, justify ongoing development of SECTA toward commercialization and we are continuing forward with the development of this therapy.
“Furthermore, this outcome has no bearing on our DNA delivery technology for DNA-based immunotherapeutics and we will continue to advance our trial and partnering activities in this field as well.”