ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), announced that Surasak Phuphanich, MD, Principal Investigator of the Phase I clinical trial of ImmunoCellular's lead dendritic cell cancer vaccine candidate for glioblastoma multiforme (GBM) presented safety and preliminary efficacy data yesterday at the American Academy of Neurology (AAN) 63rd Annual Meeting. Dr. Phuphanich, Director of the Neuro-Oncology Program in the Departments of Neurosurgery and Neurology and Professor of Medicine at Cedars-Sinai Medical Center, reported that of 16 newly-diagnosed patients with GBM enrolled between May 2007 and November 2009, 11 (69%) are still alive. Furthermore, six (38%) continue to show no tumor progression for more than two years without disease progression. No serious adverse events were reported, and minor side effects have been limited to fatigue, skin rash and pruritis.
“These data demonstrate that our dendritic cell vaccine, ICT-107, which was designed to target both cancer cells and cancer stem cells, has the potential to significantly delay disease recurrence, and thus increase survival in GBM”
Overall two-year survival for patients treated with ICT-107 was 80%, compared to historical rates for overall survival on standard treatment of 26% in all GBM and 38% in GBM patients whose tumor is completely resected (Stupp et al, NEJM 2005). Median overall survival has not yet been reached. Median Progression-Free Survival (PFS) for patients receiving the cancer vaccine was 16.9 months, comparing favorably with historical PFS of 6.9 months for patients receiving standard treatment, and two-year PFS for vaccine-treated patients was 44%.
"These data demonstrate that our dendritic cell vaccine, ICT-107, which was designed to target both cancer cells and cancer stem cells, has the potential to significantly delay disease recurrence, and thus increase survival in GBM," said Manish Singh, Ph.D., President and CEO of ImmunoCellular Therapeutics. "Glioblastoma is a devastating cancer, with two-year progression-free-survival rate of approximately 11%. Our safety and preliminary efficacy data provided the basis for our Phase II trial of ICT-107 for GBM, which is now enrolling patients."
The vaccine is made by taking dendritic cells obtained from the patient's own (autologous) blood, and mixing them with certain manufactured proteins known to be present on cancer cells and cancer stem cells. Patients underwent three vaccinations, along with follow-up clinic visits to check their status, after they had received the standard treatment of surgery, radiation and chemotherapy.
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