ImmunoCellular Therapeutics (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced long-term data from a Phase I clinical trial of ICT-107, the Company's lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The data show six out of 16 (37.6%) patients who received ICT-107 were disease-free after more than two years, with three of these patients (18.8%) remaining disease-free for more than three years. One of these patients remains disease-free after almost four years. No treatment-related serious adverse events have been observed to date.
"These data continue to demonstrate the potential of targeting cancer stem cells to significantly delay disease recurrence and thereby increase survival in GBM," said Manish Singh, Ph.D., president and CEO of ImmunoCellular Therapeutics. "Glioblastoma is a devastating disease that is associated with a two-year progression-free survival rate of approximately 11%, and a three-year progression-free survival rate of less than 5%. We are therefore highly encouraged by the substantially extended progression-free survival rates we have seen thus far, which we expect to increase as we continue gathering data from this study. We look forward to further investigating the potential of ICT-107 in a larger Phase II clinical study, which we are on track to commence later this year."
The Phase I clinical study was conducted in 16 newly diagnosed glioblastoma patients, who received three injections of ICT-107 in addition to standard treatment with surgery, radiation and chemotherapy. Earlier this year, the Company reported two-year survival rates of 80% in study patients, which compares favorably to the historic median two-year survival rate of 26.5% with standard of care alone. The study's median progression-free (PFS) survival of 17.7 months compared especially favorably to the historic median PFS of 6.9 months. Eleven of the 16 patients continue to survive. No serious adverse events have been reported and minor side effects have been limited to fatigue, skin rash and pruritis.
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