Northwest Biotherapeutics, Inc. awarded a contract to Synteract for the clinical trial management of its Phase II trial to evaluate DCVax-Brain in patients with Glioblastoma multiforme. DCVax-Brain is a personalized therapeutic cancer vaccine using the patient's own dendritic cells (immune cells) with the patient's own tumor biomarkers (antigens).
"We are pleased to be working with Synteract in this important clinical trial given their longstanding expertise in successful clinical trial management," stated Alton Boynton, Ph.D., president of Northwest Biotherapeutics. "It will be particularly useful, as this Phase II trial has the potential to become one of the first cancer immunotherapies, an entirely new class of treatment for brain cancer."
Stewart Bieler, senior vice president of clinical operation and project management at Synteract, said, "We are enthusiastic about working with Northwest Biotherapeutics to bring one of the first personalized medicines into a late stage clinical trial -- especially for a disease like brain cancer, for which very few treatments currently exist and for which the prognosis is especially dire."
This Phase II trial is based on two Phase I trials demonstrating that patient survival was more than twice as long for patients receiving DCVax-Brain treatment than for patients receiving either of the two currently FDA-approved therapies.