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). To date, the Company has initiated the trial in 12 centers, with plans to increase the overall number of sites to 20 or more. ImmunoCellular has received Institutional Review Board (IRB) approval from a total of 18 trial sites. IRB approval is required prior to conducting clinical trials at medical centers. The trial is expected to enroll approximately 150-160 patients to treat 102 patients with HLA-A1/A2 immunological subtypes. There are 36 patients enrolled in the study to date. Enrollment for the trial is expected to be completed by Q2, 2012 and an interim analysis is expected at the end of 2012.
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 our Phase II trial for the treatment of glioblastoma multiforme, said Manish Singh, Ph.D., President and CEO of ImmunoCellular Therapeutics. "We are encouraged by the strong interest we have received from the medical community, and the role that leading oncologists are playing in supporting our efforts to enroll patients." In 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 a one year overall survival of 100 percent and a two year survival of 80 percent. This compares favorably with historical 61.1 percent one-year and 26.5 percent two-year survival based on the standard of care alone. The study's median progression free survival (PFS) of 16.9 months compared favorably to the historic median PFS of 6.9 months. The most recent data presented at ASCO showed 6 out of the 16 (37.6%) newly diagnosed patients who received ICT-107 had no tumor recurrence, with 3 of these patients (18.8%) remaining disease-free for almost four years while the other 3 patients had gone more than 2 and a half years disease-free. No treatment related serious adverse events have been observed to date.
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