Date: 2016-06-07
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: ImmunoCellular Therapeutics (USA - CA)
Product: ICT-107 with maintenance temozolomide
Action
mechanism: cell therapy/immunotherapy product. ICT-107 is a dendritic cell vaccine prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells.
Disease: glioblastoma
Therapeutic area: Cancer - Oncology - Rare diseases
Country: Canada, Switzerland, USA
Trial
details: This Phase 3 study is evaluating ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells. (NCT02546102)
Latest
news: * On June 7, 2016, ImmunoCellular Therapeutics announced that the first patient has been treated in the phase 3 registrational trial of ICT-107 in newly diagnosed glioblastoma. This trial is designed as a randomized, double-blind, placebo-controlled study of 414 HLA-A2-positive subjects, which will be conducted at approximately 120 sites in the US, Canada and the EU. The primary endpoint in the trial is overall survival, which the FDA and EU regulators have identified as an appropriate endpoint for registrational clinical studies in glioblastoma. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups. ImmunoCellular Therapeutics now looks forward to treating the first patients in Canada and Europe in the third quarter of 2016. The principal investigator on the trial is Prof. Dr. Michael Weller, Chairman, Department of Neurology, University Hospital Zurich, Switzerland. Dr. Weller serves as the Chairman of the German Glioma Network of the German Cancer Council, and serves as President of the European Association for Neuro-Oncology (EANO). He is also the Chairman of the Brain Tumor Group of the European Organisation for Research and Treatment of Cancer (EORTC). A world expert in glioblastoma treatment and research, Dr. Weller has provided extensive support to ImmunoCellular relative to interpretation of the phase 2 results and design of the phase 3 trial protocol, and served as the Company's clinical expert in our end of phase 2 presentation to the European Medicines Agency (EMA).
ImmunoCellular has reached agreement with the US FDA on a Special Protocol Assessment (SPA) relative to the primary and secondary endpoints as well as the statistical plan for the phase 3 trial. ImmunoCellular has also been honored with a $19.9 million award from the governing Board of the California Institute for Regenerative Medicine (CIRM), California's stem cell agency, to implement the phase 3 registration trial. To support timely patient enrollment at participating sites across ten countries, ImmunoCellular has established agreements with the European Organisation for Research and Treatment of Cancer (EORTC), the Alliance for Clinical Trials in Oncology (the Alliance) in the US, and the Canadian Brain Tumor Consortium.
