Gliovac (ERC1671) is an anti-cancer vaccine being developed by Epitopoietic Research Corporation as a potential therapy for patients with advanced glioblastoma multiforme (GBM), an aggressive and fast-growing type of brain tumor.
How Gliovac works
Gliovac is composed of whole tumor cells and cell fragments taken from the patient and three other donors with the same type of cancer.
By receiving tumor cells from different people, the patient’s immune system is exposed to several different tumor-associated antigens (TAA), or proteins, minimizing the chance that tumor cells might escape from the body’s defenses. It also is believed this approach will trigger a stronger cytotoxic T-lymphocyte (CTL, or a “cell-killing” T-cell) response against the TAA on the patient’s tumor.
It is hoped that this strategy, in combination with the immune response inherent in the patient’s own cells, might lead to the elimination of glioblastoma cells.
Gliovac in clinical trials
Gliovac was first tested under a U.S. Food and Drug Administration (FDA)-approved compassionate use/hospital exemption protocol in nine patients with recurrent GBM who had failed to respond to standard treatments and had no other treatment options. Gliovac was injected into the skin, and given with Leukine (GM-CSF) and low-dose Cytoxan (cyclophosphamide), a chemotherapy. The results showed that Gliovac was safe and potentially effective in treatment-resistant GBM patients, enhancing the overall survival in all nine patients.
Based on these results, the FDA approved a Phase 2, double-blind, placebo-controlled clinical trial (NCT01903330) in recurrent GBM patients. This trial will evaluate the safety and effectiveness of Gliovac in combination with Leukine and Cytoxan, plus the cancer medicine Avastin (bevacizumab). The trial is currently enrolling up to 84 patients at one site in California; information is available by clicking on its identification number.
The most common adverse effects associated with Gliovac, noted in the compassionate use study, included headaches and infusion site reactions.
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