38% of patients disease free at 3 years
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, today announced updated long-term data from a Phase I clinical trial of ICT-107, the Company's lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. Three-year overall survival is 55% compared to 16% based on historical standard of care (SOC). The data show that 38% of newly diagnosed patients who received ICT-107 continue to show no tumor recurrence after three years, compared to the historic disease-free survival rate of 6% with SOC. Out of these patients, 19% remain disease-free after more than four years.
“Patients receiving ICT-107 continue to demonstrate substantially longer overall and progression-free survival rates compared to historical standard of care, providing further evidence of ICT-107’s potential to provide urgently needed improvements in GBM treatment,” said Manish Singh, president and CEO of ImmunoCellular Therapeutics. “As we continue enrolling our Phase II study in GBM, the strength of this three-year Phase I data reinforces our confidence that we will continue to see a clear survival benefit, in addition to excellent safety, in patients treated with ICT-107.”
The three-year median overall survival (OS) for patients receiving ICT-107 is currently 38.4 months, and median progression-free survival (PFS) is 17 months. This compares favorably to the historical median OS of 14.6 months and PFS of 6.9 months with SOC. Additional data from the Phase I trial showed that the 12-month disease-free survival rate from the time of surgery was 75 percent with ICT-107, compared with the historical control of 26.9 percent, and the 24 month disease-free survival with ICT-107 was 43.8 percent, compared with 10.7 percent historically.
The Phase I clinical study was conducted in 16 newly diagnosed glioblastoma patients, who received three injections of ICT-107 in addition to standard treatment with surgery, radiation and chemotherapy. The company has previously reported a two-year survival rate of 80.2% in study patients, which compares favorably to the historic median two-year survival rate of 26.5% with SOC alone. No serious adverse events have been reported and minor side effects have been limited to fatigue, skin rash and pruritis.
ImmunoCellular Therapeutics is currently conducting a double-blind, placebo-controlled, 2:1 randomized Phase II study is designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study will treat 102 patients and will be conducted at over 20 clinical trial centers in the U.S. in collaboration with leading experts and opinion leaders in neuro-oncology.
About ImmunoCellular Therapeutics, Ltd.
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
Forward-Looking Statements
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.
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical
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