In April 2012, the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) approved a study of the HSPPC-96 vaccine in a large, randomized Phase 2 trial in combination with Avastin ® (bevacizumab; Genentech/Roche) in patients with surgically resectable recurrent GBM. The study is being sponsored by the Alliance for Clinical Trials in Oncology (referred to as the "Alliance"), an NCI cooperative group formed by the merger of the American College of Surgeons Oncology Group (ACOSOG), Cancer and Leukemia Group B (CALGB), and the North Central Cancer Treatment Group (NCCTG).
The trial is intended to investigate the combination of HSPPC-96 and bevacizumab in a three-arm study of approximately 220 patients with surgically resectable recurrent GBM with the primary endpoint to assess overall survival. The study would compare efficacy of the HSPPC-96 vaccine given with bevacizumab either concomitantly or at progression, versus bevacizumab alone, in the therapy of surgically resectable recurrent GBM. This study design is supported, in part, by a theoretical synergistic effect between HSPPC-96 and bevacizumab. The protocol for this trial is currently undergoing final review and the trial should be initiated around the end of 2012 or early 2013.
The study aims to advance the treatment of GBM, the most common and most malignant form of brain cancer. The potential clinical benefits of Prophage Series vaccine continue to be reported in peer-reviewed publications and at major international medical meetings.
Dr. Parsa has not received any financial support or travel expense reimbursement for this work or for consulting activities on behalf of Agenus. Dr. Parsa does not have an equity interest in Agenus or a financial relationship with the company.About Glioblastoma Multiforme (GBM) The incidence rates of primary malignant brain and central nervous system (CNS) cancers have increased over the last three decades. The American Cancer Society estimates that more than 22,000 malignant tumors of the brain or spinal cord were diagnosed during 2010 in the US and that more than 13,000 people would die from these tumors. Glioblastoma is the most common primary malignant brain tumor and accounts for the majority of diagnoses and has been associated with a particularly poor prognosis, with survival rates at 1 and 5 years equaling 33.7% and 4.5%, respectively. The current standard of care for patients with newly diagnosed glioblastoma is surgical resection followed by fractionated external beam radiotherapy and systemic temozolomide resulting in a median overall survival (OS) of 14.6 months based on data from a randomized Phase III trial. Although this treatment can prolong survival, it is not curative and the vast majority of patients with glioblastoma experience recurrent disease, with a median time to recurrence of 7 months. Currently, there is no standard treatment for patients with recurrent glioblastoma, although additional surgery, chemotherapy (i.e., CCNU, temozolomide), bevacizumab, and radiotherapy are used.
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