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IMUC > SEC Filings for IMUC > Form 8-K on 7-Jun-2016All Recent SEC Filings

Show all filings for IMMUNOCELLULAR THERAPEUTICS, LTD.

Form 8-K for IMMUNOCELLULAR THERAPEUTICS, LTD.


7-Jun-2016

Other Events


Item 8.01. Other Events.

On June 7, 2016, ImmunoCellular Therapeutics, Ltd. (the "Company") announced that the first patient has been treated in the phase 3 registrational trial of ICT-107, the Company's lead cancer immunotherapy product candidate, in newly diagnosed glioblastoma. ICT-107 is a patient-specific, dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. The phase 3 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 United States, Canada and the European Union. The primary endpoint in the trial is overall survival, which the U.S. Food and Drug Administration and European Union 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.

Cautionary Statement Regarding Forward-Looking Statements

This Current Report on Form 8-K 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 and whether the results will support registration filings with the U.S. Food and Drug Administration or European Medicines Agency. Additional risks and uncertainties are described in the Company's most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Except as permitted by law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


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