ImmunoCellular Therapeutics, Ltd (OTCBB: IMUC) today announced it will be presenting new data from the Phase I clinical trial of ICT-107, the Company's lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM). The abstract titled, “Glioma-associated antigens associated with prolonged survival in a phase I study of ICT-107 for patients with newly diagnosed glioblastoma” (Abstract #2042) will show that there is a correlation between the immunological response that ICT-107 generated in the form of antigens and both progression-free and overall survival. These observations suggest that targeting antigens highly expressed by cancer stem cells (CSCs) is a promising strategy for treating patients with glioblastoma. The abstract has been accepted for presentation on June 4, 2011 in the Central Nervous System Tumors General Poster Session at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.
Tumor analyses for expression of the six antigens targeted by ICT-107 - HER-2, TRP-2, gp100, MAGE1, IL-13R?2, and AIM-2 - revealed all patients exhibited at least three of these antigens, and 75% exhibited all six. Correlations were observed between increased PFS and quantitative expression of MAGE1 (p=0.03), gp100 (p=0.05), AIM2 (p=0.003), and HER2 (p=0.04), the latter two of which are highly expressed by GBM cancer stem cells (CSCs). It is widely believed that CSCs play a significant role in tumor resistance and recurrence.
Patients who demonstrated immunological response to vaccination with ICT-107 had longer PFS compared to non-responders. Responders also exhibited a trend toward longer OS. Patients who had recurrences after vaccination exhibited decreased levels of CD133, a biomarker of CSCs. In contrast, previous studies demonstrated an increase in CD133 expression in patients who underwent treatment with radiation and chemotherapy.
This new data follows previously announced two-year results showing an overall survival (OS) rate of 80% and a progression-free survival (PFS) rate of 44%, which compare very favorably to historic median survival rates with standard of care alone. At a median analysis time of 32 months, 11 out of 16 patients in the trial were still alive (69%) and 6 out of 16 (38%) continued to be disease-free.
"The impressive survival data we have seen to date, combined with the correlations we have observed between immunologic response and clinical outcome, further build our confidence that targeting CSCs represents a promising approach to treating GBM," said Manish Singh, Ph.D., ImmunoCellular's president and CEO. "Furthermore, these findings provide further validation of immunotherapy as a therapeutic strategy for seeking out and destroying CSCs and preventing tumor recurrence. We look forward to further investigating the potential of ICT-107 to provide a safe and effective treatment option for GBM in our ongoing Phase II study."
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 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.
James Young, 212-732-4300