ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular" or the "Company") (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, provided an update today on clinical trial site activity and patient enrollment for its Phase II clinical trial of ICT-107, the Company's dendritic cell based cancer vaccine candidate targeting multiple tumor antigens for the treatment of glioblastoma multiforme (GBM). The Company has initiated the trial in 23 centers and has received Institutional Review Board (IRB) approval from a total of 24 trial sites. The trial is expected to enroll approximately 160-200 patients to treat 102 patients with HLA-A1/A2 immunological subtypes. There are 115 patients enrolled in the study to date, ahead of the Company's schedule. Enrollment for the trial is expected to be completed by the second quarter of 2012 and an interim analysis is expected when 50% of events (32 deaths) have been observed.
The Phase II trial of ICT-107 is a double-blind, placebo-controlled, 2:1 randomized study designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study is enrolling patients at medical institutions in collaboration with leading experts and opinion leaders in neuro-oncology at those sites.
"We are pleased with the progress we have made in enrolling patients for the Phase II trial," said Manish Singh, Ph.D., President and CEO of ImmunoCellular Therapeutics. "The strong interest and support from the medical community, especially from leading oncologists, has allowed us to enroll patients in many of the top medical centers in the country, reflecting the potential that ICT-107 has demonstrated in treating GBM."
The Phase I clinical study of ICT-107 in GBM, 16 newly diagnosed patients who received the vaccine in addition to standard of care of surgery, radiation and chemotherapy demonstrated two year overall survival of 80 percent and a three year survival of 55 percent. These figures compare favorably to the 26 percent two-year and 16 percent three-year survival based on the historical standard of care treatment alone. The median overall survival was 38.4 months compared to 14.6 months for the historical standard of care. The study's median progression free survival (PFS) of 16.9 months compared favorably to the historic median PFS of 6.9 months. Six out of the 16 (37.6%) newly diagnosed patients who received ICT-107 continue to show no tumor recurrence at the last analysis, with 3 of these patients (18.8%) remaining disease-free for more than 4 years while the other 3 patients had gone more than 3 years disease-free. There have been no serious adverse treatment related symptoms observed in any of the patients.