ImmunoCellular Therapeutics, a clinical-stage company developing immune-based therapies for the treatment of brain and other cancers, today said that the Data Monitoring Committee (DMC) has completed a pre-specified interim analysis of the ICT-107 phase II clinical trial in patients with newly diagnosed glioblastoma. Furthermore, DMC recommended that the company continue the trial to completion, which the company anticipates will be by year end.
The ICT-107 study is structured so that interim analysis is conducted by the independent DMC after 32 events (patient deaths) are reached - IMUC remains blinded to the actual results and details of the interim analysis as well as to any patient data from the ongoing trial. No additional interim analyses are planned.
"We are pleased with the outcome of the DMC's interim analysis and look forward to completing the ongoing phase II trial of ICT-107," Andrew Gengos, ImmunoCellularCEO, stated in the press release. "We have been pleased with the rate of enrollment and appreciate the diligence of the DMC, our trial site collaborators, and our dedicated clinical team in achieving this important milestone in our Company's progress. The results of this trial will serve as the basis for determining the next clinical and regulatory steps in the development of what we believe is a promising new approach to treating this highly lethal cancer."
The ICT-107 phase II trial is a randomized, placebo-controlled, double-blind study of ICT-107, a 6-antigen dendritic cell vaccine targeting glioblastoma tumor and cancer stem cell antigens. The phase II trial has been fully enrolled and a total of 124 patients have been randomized at 25 clinical trial sites in the United States. The primary endpoint of the trial is overall survival, while secondary endpoints include progression-free survival, is overall survival, and progression-free survivalat various time intervals, immune response (T cells) and safety.
For more information visit www.imuc.com
Please see disclaimer on the MissionIR website