Enrollment Expected to Occur at Minimum of 20 Centers
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 the expansion of sites for its Phase II clinical trial of ICT-107. ICT-107 is the Company’s dendritic cell based cancer vaccine candidate targeting multiple tumor antigens for the treatment of glioblastoma multiforme (GBM). The Company had initially planned to conduct the study, which is now underway, at up to 15 clinical centers, but has increased the number of anticipated sites to 20 or more. ImmunoCellular has qualified 21 sites so far and has submitted the trial to 12 prospective sites' Institutional Review Board (IRB) for approval. Of these 12 sites, 6 have received their IRB approval.
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 excited to accelerate and expand site enrollment of our Phase II clinical trial for ICT-107,” said Manish Singh, Ph.D. president and CEO of ImmunoCellular Therapeutics. “With this trial we look forward to generating data in support of the safety and efficacy of ICT-107 in the treatment of GBM and to further support the promising outcomes reported in our Phase I study.”
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 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; 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; and the risk of obtaining patent coverage for ICT-107 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.
James Young, 212-732-4300
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