Transgene: Agreement with FDA Announced for Special Protocol Assessment for Upcoming Phase 3 Pexa-Vec Trial in Advanced Liver Cancer

le
0
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.

Si le fichier PDF ne s'affiche pas ou pour le télécharger, cliquez ici.

Pour consulter le fichier PDF en intégralité, cliquez ici.

Pour visualiser les documents au format PDF, vous pouvez télécharger gratuitement Acrobat Reader XI.


Valeur associée
  Libellé Bourse Dernier Var. Vol.
Vous devez être membre pour ajouter des commentaires.
Devenez membre, ou connectez-vous.
Aucun commentaire n'est disponible pour l'instant