Clinical stage vaccine company Immunovaccine has decided to test DPX-Survivac in a European Phase II trial in patients with Glioblastoma (malignant primary brain tumour).
Expected to start in the fourth quarter of 2013, the placebo-controlled, randomised study will enrol over 50 newly diagnosed brain tumour patients.
DPX-Survivac therapy, which targets survivin peptides present on most glioblastoma cells, will be assessed in combination with temozolomide, the immune modulating drug, in an effort to extend remission.
The University of Rome Department of Experimental Medicine professor and trial lead Dr Marianna Nuti said; "This type of tumor has been demonstrated to express survivin at a high level and DPX-Survivac has demonstrated promising immunogenicity in a clinical trial in ovarian cancer patients."
Randomising patients with either DPX-Survivac, a dendritic cell (DC) based survivin vaccine, or the standard of care with a placebo vaccine, the study's primary goal is to find the efficacy of DPX-Survivac.
Progression-free survival and overall survival subsequent to proposed combination therapy are the secondary endpoints of the trial, with initial data anticipated in the second half of 2014.
Immunovaccine chief science officer Marc Mansour given the broad utility of survivin vaccine across different cancer types, glioblastoma is considered as a good setting for testing the immunologic effects of DPX-Survivac.
"This trial allows us to test DPX-Survivac with an interesting immune modulator and in a minimal residual disease setting," Mansour said.
Patients administered with DPX-Survivac along with cyclophosphamide in a Phase I trial demonstrated targeted immune responses, whereas few even presented circulating target and sustained specific T cells (CD8 T cells) in their blood without exhibiting any systemic side-effects or dose-limiting toxicities.
Image: Histopathological image of cerebral glioblastoma. Hematoxylin & esoin stain. Photo: KGH.