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news.ImmunoCellular Therapeutics 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).
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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.