ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) today provided an update on current and anticipated corporate milestones.
- Our Phase IIb randomized, placebo-controlled, double-blind clinical trial of ICT-107, a dendritic cell vaccine targeting glioblastoma antigens and cancer stem cells, continues to progress well. A total of 278 patients have been enrolled at 25 centers in the US, and 124 patients have been treated. In early 2013, we anticipate that the Data Safety Monitoring Committee will conduct an interim safety and futility analysis based on 50% of events. We expect final top-line results after the 100% event level is reached, which we anticipate 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 have filed 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. Pending acceptance of the IND by the US FDA, we anticipate conducting a Phase I trial in the second half of 2013.
- In the first quarter of 2013, we anticipate the initiation of an investigator-sponsored Phase I trial of ICT-121, a dendritic cell vaccine targeting CD133, in patients with recurrent glioblastoma. ImmunoCellular is supporting this trial, which will enroll approximately 20 patients and will be conducted at Cedars-Sinai Medical Center.
“We believe that 2013 will be an exciting year of progress for ImmunoCellular, and for the field of cancer vaccines, which has the potential to significantly improve clinical outcomes for cancer patients,” said Andrew Gengos, ImmunoCellular Chief Executive Officer. “We appreciate the broad support for our development programs within the medical oncology community, and look forward to advancing our programs and strengthening our position as an emerging leader in cancer immunotherapy.”
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 is conducting a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma. ImmunoCellular's pipeline also includes ICT-121, a dendritic cell vaccine targeting CD133, and ICT-140, a dendritic cell vaccine targeting ovarian cancer antigens and cancer stem cells. 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. 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.
ImmunoCellular Therapeutics, Ltd.
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