Study Investigating Vaccine To Treat Brain Tumors Underway
[Some more info on the Celldex trial. Isn't it strange how Medarex - who owns the majority of Celldex' equity - and Celldex almost seem to pretend that the other party doesn't exist? There is no mention in the pipeline section on Medarex' website, that there is a majority-owned cancer vaccine going into a pivotal trial].
Researchers have begun ACT III – a Phase II/III Randomized Study – to investigate the addition of CDX-110 vaccine to standard care maintenance chemotherapy in patients with newly diagnosed glioblastoma multiforme (GBM), the most aggressive form of primary brain tumor.
CDX-110 (Celldex Therapeutics, Inc.) is an experimental vaccine that is being investigated to treat GBM by activating the immune system to fight the cancer. Approximately half of GBM tumors contain a protein called EGFRvIII, which has only been found in cancer cells. The purpose of CDX-110 is to "train" the immune system to recognize EGFRvIII. In patients whose tumors contain EGFRvIII, this should cause the immune system to kill the GBM cells.
"We are excited to begin enrolling patients in this study, as CDX-110 gets at the genetic cause of these tumors, which could lead to improved time to progression and overall survival for GBM patients," says Donald M. O'Rourke, MD, Associate Professor, Department of Neurosurgery, University of Pennsylvania School of Medicine.
The study will enroll patients 18 years of age or older with newly diagnosed GBM, and whose tumors contain EGFRvIII. Enrolled patients will be randomized to receive either standard of care maintenance chemotherapy with temozolomide, or standard of care plus injections of CDX-110.
The Phase II portion of the ACT III trial will enroll 90 patients, and if improved disease control is seen at six months, an additional 285 participants will be enrolled for the Phase III portion of the trial.
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