South Korean biotech SillaJen reached an accord with the U.S. Food and Drug Administration on a Special Protocol Assessment for a global Phase III clinical trial of its oncolytic immunotherapy, Pexa-Vec.
The company said the trial will evaluate the use of Pexa-Vec to treat patients with advanced liver cancer, also known as hepatocellular carcinoma, who have not received sorafenib (Nexavar) therapy, and subsequently made an oral and poster presentation of research at the Annual Meeting of the American Association for Cancer Research in San Francisco on Pexa-Vec (JX-594).
Enrollment is expected to begin later this year by the privately held, clinical-stage biotherapeutics company.
- here are the SillaJen release and the presentation