Immunovaccine has agreed to use its lead cancer product, DPX-Survivac, in a Phase II study based in Rome designed to extend life for glioblastoma (GBM) patients. Four major trial centres across Italy will be involved, with the cost of the trial being assumed by the University of Rome. The randomised, placebo-controlled study will enrol more than 50 patients with newly diagnosed brain tumours that have been maximally resected, and is expected to start in the fourth quarter of 2013.
The trial will evaluate DPX-Survivac therapy in combination with temozolomide, the standard of care (SoC) therapy for newly-diagnosed GBM patients following surgery and radiation. It has been reported to have immune-modulating effects, making it a suitable drug to combine with cancer vaccines. DPX-Survivac will be applied only during the temozolomide maintenance phase. Patients will be randomised into three groups to receive either DPX-Survivac; a dendritic cell-based survivin vaccine; or the SoC with a placebo vaccine. The primary goal is to evaluate the effectiveness of DPX-Survivac. Secondary endpoints will include progression-free survival and overall survival following the proposed combination therapy. Initial data from this trial are expected in the second half of 2014.
DPX-Survivac has demonstrated promising immunogenicity in a clinical trial in ovarian cancer patients. Earlier in 2013, Immunovaccine announced positive results from the company's Phase I trial of DPX-Survivac. Data showed all patients that had received DPX-Survivac in combination with cyclophosphamide produced targeted immune responses and that there were multiple strong responders among this group who presented circulating target and sustained specific T-cells (CD8 T-cells) in their blood. Data also demonstrated that the vaccine had no systemic side effects or dose-limiting toxicities.