LOS ANGELES--(BUSINESS WIRE)-- 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.
The clinical centers currently recruiting for this clinical trial and enrollment criteria are listed at: http://clinicaltrials.gov/ct2/show/study/NCT01280552?term=ICt-107&rank=1.
About ImmunoCellular Therapeutics
IMUC is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company recently commenced a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. To learn more about IMUC, please visit www.imuc.com.
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including without limitation the need for substantial additional capital to fund development of product candidates beyond their initial clinical or pre-clinical stages; the risk that the safety and efficacy results obtained in the Phase I trial for the dendritic cell-based vaccine will not be confirmed in subsequent trials; the risk that the correlation between immunological response and progression-free and overall survival in the Phase I trial for ICT-107 will not be reflected in statistically significant larger patient populations; the risk that IMUC will not be able to secure a partner company for development or commercialization of ICT-107; the need to satisfy performance milestones to maintain the vaccine technology licenses with Cedars-Sinai; the risks associated with adhering to projected preclinical or clinical timelines and the uncertainties of outcomes of development work for product candidates; and the risk of obtaining patent coverage for the dendritic cell-based vaccine or that any patents covering this vaccine will provide commercially significant protection for this product candidate. Additional risks and uncertainties are described in IMUC's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K. IMUC undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For ImmunoCellular Therapeutics, Ltd.
Gary Nash, 212-732-4300
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