ImmunoCellular Therapeutics Ltd., a biotechnology company focused on developing immune-based therapies for the treatment of various forms of cancer, has enrolled the first of 100 patients in its phase II trial of ICT-107 at the New Jersey Neuroscience Institute at JFK Medical Center. ICT-107 is the company’s dendritic cell-based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), an aggressive type of brain tumor.
“The enrollment of the first patient in the phase II trial of ICT-107 represents a hopeful step towards the development of a more effective treatment for an extremely aggressive type of brain tumor, and may ultimately result in the drastic decrease of associated rates of mortality,” Dr. Joseph C. Landolfi, director of Neuro-Oncology at the NJ Neuroscience Institute stated in the press release.
The double-blind, placebo-controlled study is being conducted to determine the safety and efficacy of ICT-107 in patients with newly diagnosed GBM.
In the phase I clinical study of ICT-107, patients newly diagnosed with GBM who received the vaccine in addition to the 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 results are favorable in comparison to historical 61.1 percent one-year and 26.5 percent two-year survival based on the standard of care alone.
The company also reported that the 12-month disease-free survival from the time of surgery was 75 percent with ICT-107, compared with the historical control of 26.9 percent. The 24 month disease-free survival with ICT-107 was 43.8 percent, compared with 10.7 percent historically.
Six of the 16 patients (37 percent) who participated in the phase I study are reported to continue to live with no disease progression with an average time of more than 30 months. Compared to current treatments, ICT-107 showed no serious adverse events; minor side effects included fatigue, skin rash and pruritis.
For more information visit www.imuc.com