Agenus initiates enrollment in brain tumor vaccine trial
The large, randomized trial to test Heat Shock Protein Peptide Complex-96 with Avastin for treatment of recurrent glioblastoma multiforme in adults is the largest brain tumor vaccine trial ever funded by the National Cancer Institute. The trial is specifically being sponsored by the NCI's cooperative group, Alliance for Clinical Trials in Oncology.
The study is the largest vaccine study ever conducted with Avastin.
"The initiation of enrollment in this groundbreaking trial to evaluate the efficacy of treatment with HSPPC-96 in conjunction with bevacizumab in recurrent GBM represents a major milestone in efforts to develop effective vaccines for people living with brain tumors," Andrew Parsa, the study chair for the trial, said. "The significant commitment to this trial from the NCI is also a reflection of the rapidly emerging promise of vaccines as potential treatment options for millions of people with different forms of cancer."
The trial will use a three-arm design to test 222 patients with surgically resectable recurrent GBM with the primary endpoint of overall survival. The study will test efficacy of HSPPC-96 vaccine administered with Avastin either at progression or concomitantly versus treatment with Avastin alone.
GBM is the most common primary malignant brain tumor and it is associated with a poor prognosis. The survival rate of patients with GBM at year one is 33.7 percent while the survival rate at year five is 4.5 percent.
Parsa presented data at the American Society for Clinical Oncology meeting in 2011 indicating that the Prophage G-200 vaccine could help recurrent GBM patients to live longer, suggesting a potential clinical benefit.
"Our research shows that Prophage Series vaccines have the potential to play an important role in the treatment of gliomas and other forms of cancer," Garo Armen, the CEO and chairman of Agenus, said. "We are very pleased to be collaborating with the Alliance and NCI on this landmark research effort."