On July 6, 2015 ImmunoCellular Therapeutics reported the establishment of an agreement with Novella Clinical (Novella), to conduct the phase 3 registration trial of ICT-107 in patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, JUL 6, 2015, View Source [SID:1234506167]). Schedule your 30 min Free 1stOncology Demo! Novella is a full-service, global clinical research organization (CRO) providing clinical trial services to small to mid-sized oncology companies. The ICT-107 phase 3 trial will include approximately 120 clinical sites in the US, Europe and Canada, and will recruit about 400 patients with newly diagnosed glioblastoma. ImmunoCellular anticipates initiating the phase 3 trial in the fourth quarter of 2015. Know more, wherever you are: "Establishing this agreement with Novella Clinical moves us one more critical step forward in the implementation of our phase 3 ICT-107 registrational trial," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "Novella’s special expertise in oncology clinical trials, combined with their strong international network, experience working with oncology cooperative groups, and reputation for high quality, efficiency and cost-effectiveness, make them an excellent partner for our ICT-107 program. We are rapidly building the infrastructure for our phase 3 program and remain on track to initiate the trial later this year."
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Novella’s President Richard Staub added, "We are proud and very pleased to be selected to support this proprietary oncology immunotherapy platform for glioblastoma. We look forward to working alongside ImmunoCellular to navigate the development and successful execution of this pivotal program to ultimately benefit patients."