ImmunoCellular Therapeutics, a biotech company focused on the development of novel immune-based cancer therapies, today issued an update on clinical trial site activity and patient enrollment for its phase II clinical trial of ICT-107, the company’s cancer vaccine candidate targeting multiple tumor antigens for the treatment of glioblastoma multiforme (GBM), the most aggressive malignant primary brain tumor.
The company reports that it has initiated the trial in 25 sites, and that it expects to enroll approximately 200 or more patients to treat 102 patients with HLA-A1/A2 immunological subtypes. There currently are 189 patients enrolled in the study, with final enrollment expected to be completed by the second quarter of 2012.
“We are excited with the enrollment progress made in the phase II clinical trial of ICT-107,” Manish Singh, Ph.D., president and CEO of ImmunoCellular stated in the press release. “We appreciate the continued support from leading medical centers and oncologists as we move our focus from enrollment to obtaining patient data.”
The phase II trial is a double-blind, placebo-controlled, 2:1 randomized study designed to evaluate ICT-107’s safety and efficacy as treatment for patients with newly diagnosed GBM.
The company’s phase I clinical study of ICT-107 in GBM demonstrated that 16 newly diagnosed patients who received the vaccine combined with standard of care of surgery, radiation, and chemotherapy had a two-year overall survival of 80 percent and a three-year survival of 55 percent vs. the 26 percent two-year and 16 percent three-year survival based on the historical standard of care treatment alone.
ImmunoCellular reports that no serious adverse treatment related symptoms were observed in any of the patients.
For more information visit www.imuc.com
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