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-13Rα2, 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.
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."
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