The multicenter, randomized Phase II trial will evaluate Amplimexon (imexon for injection) plus gemcitabine versus gemcitabine plus placebo in approximately 124 chemotherapy naive patients with metastatic pancreatic cancer.
The purpose of the study is to determine if Amplimexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone. The study will also evaluate and compare the tolerability and toxicity of the two treatment arms. The trial is opening at clinical sites throughout the US.
Evan Hersh, executive vice president and chief medical officer of AmpliMed, said: “Amplimexon has demonstrated the ability to overcome resistance and offer an improved safety profile when combined with gemcitabine in preclinical studies of pancreatic cancer, and we look forward to evaluating the impact of this treatment in this randomized clinical trial.”