The European Medicines Agency (EMA) has granted orphan drug designation for ImmunoCellular Therapeutics’ lead product candidate ICT-107 for treatment of patients with glioblastoma.
EU orphan drug status provides sponsor companies with incentives, including a ten-year period of market exclusivity, access to a centralised review process, trial design assistance and scientific advice during product development, fee reductions, and tax incentives.
The company has previously received orphan designation for ICT-107 in glioblastoma from the Food and Drug Administration (FDA).
ImmunoCellular chief executive officer Andrew Gengos said: "Obtaining orphan designation in the EU for ICT-107 is an important achievement for our company, as we believe that it adds value to our lead asset and creates additional development, commercialisation and partnering opportunities in the European market.
"We anticipate additional milestones in the ICT-107 programme in the coming months.
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"We have submitted an abstract and hope to present at ASCO new and updated data from the Phase II programme, including immunological data analyses."
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By GlobalDataImmunoCellular plans to initiate the Phase III study later in 2014, subject to positive outcome from the end-of-Phase-II meeting with the FDA on the study protocols.
The company is currently formulating its EU regulatory strategy in preparation for its first meeting with the EMA.
It is completing its fourth-generation manufacturing process development and is planning to select a Phase III manufacturer in the second half of this year.
ICT-107 is an intradermally administered autologous vaccine that includes the patient’s dendritic cells pulsed with six synthetic tumour-associated antigens: AIM-2, MAGE-1, TRP-2, gp100, HER-2, IL-13Ra2.
The company has completed a randomised, double-blind, placebo-controlled Phase II study of the safety and efficacy of ICT-107 in newly diagnosed patients with glioblastoma multiforme following resection and chemoradiation.
Image: Orphan drug status for ICT-107 in glioblastoma in the EU. Photo: courtesy of freedigitalphotos.net.
