LOS ANGELES--(BUSINESS WIRE)-- ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular Therapeutics” or the Company”)(OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, announced the issuance of a U.S. patent relating to a technology for the treatment of cancer for which the Company holds an exclusive, worldwide license. Patent No. 7,939,090, entitled “System and method for the treatment of cancer, including cancers of the central nervous system,” covers the combination of a dendritic cell based vaccine combined either before or concurrently with chemotherapy at the recurrence of the disease. The Company believes that in the treatment of cancer, particularly cancers of the central nervous system such as glioblastoma multiforme (GBM), a dual therapeutic approach that includes the administration of a dendritic cell-based cancer vaccine combined with a regimen of chemotherapy could substantially enhance the clinical efficacy of treatment.
“This patent has applicability to multiple types of cancer, including our first clinical target, glioblastoma,” said Manish Singh, Ph.D. president and CEO of ImmunoCellular Therapeutics. “ICT-107, the Company’s dendritic cell based vaccine candidate for the treatment of GBM, elicits a cytotoxic tumor reactive response that in combination with chemotherapy might fundamentally alter tumors by priming their death machinery.”
ImmunoCellular Therapeutics recently announced the expansion of its Phase II trial of ICT-107 from up to 15 clinical centers to 20 or more. 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 well known experts and opinion leaders in neuro-oncology at those sites.
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. The study’s median progression free(PFS) survival of 16.9 months compared favorably to the historic median PFS of 6.9 months. 10 of the 16 patients continue to survive. 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 data shows 6 out of the 16 (37.6%) newly diagnosed patients who received ICT-107 continue to show no tumor recurrence, with 3 of these patients (18.8%) remaining disease-free for almost four years while the other 3 patients have gone more than 2 and a half years disease-free. No treatment related serious adverse events have been observed to date.
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.
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including without limitation the risk that the issued patent covering IMUC’s vaccine technology will not provide commercially significant protection for IMUC’s products and that additional patents covering this technology will not be issued or will not provide commercially significant protection for IMUC’s products; the risk that the safety and efficacy results obtained in the Phase I trial for ICT-107 will not be confirmed in subsequent trials; the risk that results obtained in the Phase II trial for ICT-107 will not be reflected in statistically significant larger patient populations; the need for substantial additional capital to fund development of product candidates beyond their initial clinical or pre-clinical stages; 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; and the risks associated with adhering to projected preclinical or clinical timelines, including delays in enrolling patients in clinical trials, and the uncertainties of outcomes of development work for product candidates. 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.
ImmunoCellular Therapeutics, Ltd.
James Young, 212-732-4300
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Oncology Pharmaceutical Managed Care