ImmunoCellular Therapeutics Announces Recommendation of Data Monitoring Committee to Continue ICT-107 Phase II Trial Following Interim Analysis
Study Completion Anticipated by Year-End 2013
The trial design for the ICT-107 study provides for the interim analysis
to be conducted by the independent DMC after 32 events (patient deaths)
"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," said
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, as a potential treatment for patients with newly diagnosed glioblastoma. The phase II trial has been fully enrolled, and a total of 124 patients have been randomized at 25 clinical trial sites in the US. The trial utilizes a one-third, two thirds design: one third of the patients are treated with placebo, which is their own dendritic cells not exposed to antigen, and the treatment arm includes two thirds or about 80 patients who receive the ICT-107 vaccine. The regimen is four induction doses after radiation and chemotherapy, and then maintenance doses until the patient relapses. The primary endpoint of the trial is overall survival (OS). Secondary endpoints include progression-free survival (PFS), OS and PFS at various time intervals, immune response (T cells) and safety.
Forward-Looking Statements for
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the risk that ICT-107 can be further successfully developed or commercialized or that the interim results are indicative of potentially favorable outcome from the study. Additional risks and uncertainties are described in IMUC's most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Except as permitted by law, IMUC undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
News Provided by Acquire Media