ImmunoCellular Therapeutics, Ltd. (ImmunoCellular), clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers, announced the establishment of an agreement with a major cancer research group, Alliance Foundation Trials, LLC (AFT), for the phase 3 registrational trial of its cancer immunotherapy ICT-107 in patients with newly diagnosed glioblastoma. AFT in conjunction with the Alliance for Clinical Trials in Oncology comprises nearly 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States. AFT will support the phase 3 trial by providing access to its large network of clinical sites and patients, with the goal of accelerating patient enrollment in the trial. Multiple phase 3 clinical trial sites have been opened for patient enrollment in the US, with additional sites anticipated to open in Canada and Europe in the coming weeks and months.
Andrew Gengos, ImmunoCellular chief executive officer, commented: "Working in collaboration with AFT has the potential to significantly accelerate enrollment in the ICT-107 phase 3 trial, and to engage the participation of important clinical sites throughout in the US. AFT is one of the most highly respected cancer organizations in America, and we are appreciative of their endorsement and support for our registrational trial."
ImmunoCellular has reached agreement with the FDA on a Special Protocol Assessment (SPA) with respect to the primary and secondary endpoints as well as the statistical plan for the phase 3 trial. ImmunoCellular has also been awarded a $19.9 million grant from the governing Board of the California Institute for Regenerative Medicine (CIRM), California's stem cell agency, to implement the phase 3 registration trial.
Alliance Foundation Trials, LLC (AFT) is a research organization that develops and conducts cancer clinical trials, working closely with pharmaceutical partners, research collaborators and the Alliance for Clinical Trials in Oncology member network.