ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular" or the "Company") (OTCBB:IMUC.OB), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced updated 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 6 out of 16 (37.6%) newly diagnosed patients who received ICT-107 continue to show no tumor recurrence, with 3 of these patients (18.8%) remaining disease -free for almost four years while the other 3 patients have gone more than two and a half years disease-free. No new patients have shown disease recurrence since the last report of data in September, 2010. No treatment-related serious adverse events have been observed to date.
"The additional long-term data demonstrate that ICT-107 provides clinical benefit far beyond the standard of care to patients with glioblastoma multiforme, and support the Phase II trial of ICT-107," said Manish Singh, Ph.D. president and CEO of ImmunoCellular Therapeutics. "We are very encouraged that the additional time spent following the patients further supports the outcomes previously reported in our Phase I study."
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. The company has reported two year median survival rate of 80.2% 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 16.9 months compared especially favorably to the historic median PFS of 6.9 months. 10 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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