BioVex announced that a Phase 3 study with OncoVEXGM-CSF vaccine for the first line treatment of patients with locally advanced squamous cell carcinoma of the head & neck (SCCHN) has commenced. The study design agreed with the FDA under the Special Protocol Assessment (SPA) process and is based on the design of BioVex’s previous study in SCCHN. The Phase 3 study will enroll 528 previously untreated patients with locally advanced disease. The primary objective of the study will be to demonstrate a statistically significant increase in two year event free survival (relapse, progression, or death) for patients treated with chemo-radiation together with OncoVEXGM-CSF compared to patients treated with chemo-radiation alone.
OncoVEXGM-CSF is a first in class oncolytic vaccine which replicates selectively in tumors destroying cancer cells while leaving surrounding healthy cells unharmed.
For more information call (781) 376-4900 or visit www.biovex.com.