- Our Phase IIb randomized, placebo-controlled, double-blind clinical trial of ICT-107, a dendritic cell vaccine targeting glioblastoma antigens and cancer stem cells, is progressing well. We completed enrollment of 278 patients on time, and that trial is being conducted at 25 clinical sites in the US. In early 2013, we anticipate that the Data Safety Monitoring Committee will conduct an event-driven interim safety analysis, and that final results will be available in late 2013. The primary endpoint of this trial is overall survival (OS), with secondary endpoints of progression-free survival (PFS), OS and PFS at various time intervals, immune response (T cells) and safety.
- We are on track to file an Investigational New Drug (IND) application for ICT-140, a dendritic cell vaccine targeting ovarian cancer antigens and cancer stem cells at the end of 2012.
- We are planning to initiate a 20-patient, investigator-sponsored Phase I trial of ICT-121, a dendritic cell vaccine targeting CD133, in patients with recurrent glioblastoma, also before the end of 2012.
- We are also pleased that ImmunoCellular’s Phase I ICT-107 data were prominently featured at the Society for Immunotherapy of Cancer (SITC) annual meeting, held October 26-28, and in SITC’s press briefing, as an exciting new breakthrough in cancer treatment.
- On November 17, we will report at the seventeenth annual meeting of the Society for Neuro-Oncology on the “Identification of immunogenic epitopes from CD133 and their potential for use to immunologically target glioblastoma cancer stem cells.” Preclinical data supporting the ICT-121 clinical trial, which targets cancer stem cells in patients with recurrent glioblastoma, will be reported.
About ImmunoCellular Therapeutics, Ltd.ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. ImmunoCellular has commenced a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma. To learn more about ImmunoCellular, please visit www.imuc.com. Forward-Looking Statements for ImmunoCellular Therapeutics 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, the timing of initiation of clinical trials for our other cancer programs and the timing of the hiring of a new Chief Executive Officer. Additional risks and uncertainties are described in IMUC’s most recently filed quarterly report on Form 10-Q, annual report on Form 10-K and other SEC reports. 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.