About the ALLIANCE Trial
The ALLIANCE trial will investigate the benefits of treatment with a combination of HSPPC-96 and bevacizumab in a three-arm design of 222 patients with surgically resectable recurrent GBM using a primary endpoint of overall survival. The study will compare efficacy of the HSPPC-96 vaccine administered with bevacizumab either concomitantly or at progression, versus treatment with bevacizumab alone. This study design is supported in part by previous research indicating a potential synergistic effect between the mechanisms of action behind both HSPPC-96 and bevacizumab.
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About Glioblastoma Multiforme (GBM)
The incidence rates of primary malignant brain and central nervous system (CNS) cancers have increased by 25 percent over the last three decades.
The American Cancer Society estimates that approximately 23,000 malignant tumors of the brain or spinal cord will be diagnosed during 2013 in the U.S. and approximately 14,000 people will die from these tumors. Glioblastoma is the most common primary malignant brain tumor and has been associated with a particularly poor prognosis, with survival rates at one and five 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 seven 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.
About the Prophage Series Cancer Vaccines
Prophage series cancer vaccines are autologous therapies derived from cells extracted from the patient's tumor. As a result, Prophage Series vaccines contain a precise antigenic 'fingerprint' of the patient's particular cancer and are designed to reprogram the body's immune system to target only cells bearing this fingerprint, reducing the risk that powerful anti-cancer agents will target healthy tissue and cause debilitating side effects often associated with chemotherapy and radiation therapy. The Prophage Series G vaccines are currently being studied in two different settings of glioma: newly diagnosed and recurrent disease.