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news.NeoPharm has said its experimental drug cintredekin besudotox for the treatment of recurrent brain cancer did not meet the efficacy endpoint of survival rate in a phase III trial.
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The study failed to show that cintredekin besudotox was as effective as current treatment, Gliadel Wafer. The wafer is implanted in the cavity the tumor once occupied after surgery and is manufactured by MGI Pharma.
The median survival time for NeoPharm’s drug was 36.4 weeks, compared with 35.3 weeks for Gliadel Wafer.
“Topline data suggests that cintredekin besudotox, while comparable, was not statistically superior to Gliadel,” said Guillermo Herrera, president and CEO of NeoPharm. “We will continue to work with our Scientific Advisory Board and the FDA to determine the best path forward.”