ImmunoCellular Therapeutics Receives Positive Regulatory Feedback from European Medicines Agency on Advancing ICT-107 to Phase III Program

LOS ANGELES, Dec. 1, 2014 /PRNewswire/ -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today announced that the European Medicines Agency (EMA) has provided scientific advice supportive of advancing ICT-107 to a registrational phase III program in patients with newly diagnosed glioblastoma (GBM). The EMA guidance is consistent with the positive feedback the Company received from the US FDA relative to the scope, design and endpoints of the program and the inclusion of patients based on HLA and MGMT status. ImmunoCellular intends to finalize the design of the phase III program, ensuring harmony between US and EU trial protocols, with the goal of being in position to initiate the phase III program. The Company now is evaluating options for funding the phase III program, which may enable the initiation in 2015.

"We appreciate the EMA's support for conducting a phase III program with ICT-107, and for their detailed guidance on the treatment design and statistical elements of the program," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "The encouragement we have received from both the US and EU regulatory authorities, and from the global neuro-oncology community, increase our confidence in ICT-107's therapeutic potential for patients with this lethal disease. We intend to complete the design of a high quality phase III program, and to explore appropriate funding alternatives to enable next steps." 

Earlier this year, ICT-107 was designated as an Advanced Therapy Medicinal Product by the EU Committee for Advanced Therapies, which should provide access in Phase III to valuable services and incentives offered by the EMA, should the Company conduct the phase III program in the EU.

About ImmunoCellular Therapeutics, Ltd.

ImmunoCellular Therapeutics, Ltd. is a Los Angeles area-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. ImmunoCellular has concluded 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, including whether the funding for the initiation and completion of the potential phase III study can be obtained and whether available funding will enable initiation of additional studies in 2015. 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.

Contact:

ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
[email protected]

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SOURCE ImmunoCellular Therapeutics, Ltd.

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