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Transgene: Agreement with FDA Announced for Special Protocol Assessment for Upcoming Phase 3 Pexa-Vec Trial in Advanced Liver Cancer
Strasbourg, France, April 16, 2015 – Transgene SA (Euronext: TNG) reported today that an agreement has been reached with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the global Phase 3 clinical trial of the oncolytic immunotherapy, Pexa-Vec. The SPA now enables Transgene, SillaJen, Inc. and the other global partners for Pexa-Vec to have clarity on the acceptability of the global Phase 3 study. The pivotal trial will evaluate the use of Pexa-Vec to treat patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC), who have not received sorafenib (Nexavar®) therapy and is expected to begin enrollment later this year.
“We are eagerly looking forward to the initiation of this trial of Pexa-Vec in patients with incurable liver cancer. Cancer immunotherapy is making a significant impact across multiple cancer types and we hope this trial will help bring a novel immunotherapy to liver cancer patients, particularly given the limited viable treatment options available to this patient population,” said Ghassan Abou-Alfa, medical oncologist at Memorial Sloan Kettering Cancer Center and lead investigator on the Phase 3 trial.