ImmunoCellular Therapeutics Announces Updated Long-Term Disease-Free Survival Data from Phase I Study in Glioblastoma
37.6% of Patients Remain Disease-Free after 30 Months
LOS ANGELES--(BUSINESS WIRE)--May 5, 2011 - 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.
About ImmunoCellular Therapeutics, Ltd.
IMUC is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company recently commenced a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. To learn more about IMUC, please visit www.imuc.com.
Forward Looking Statements
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including without limitation the need for substantial additional capital to fund development of product candidates beyond their initial clinical or pre-clinical stages; the risk that the safety and efficacy results obtained in the Phase I trial for the dendritic cell-based vaccine will not be confirmed in subsequent trials; the risk that IMUC will not be able to secure a partner company for development or commercialization of ICT-107; the need to satisfy performance milestones to maintain the vaccine technology licenses with Cedars-Sinai; the risks associated with obtaining FDA clearance to commence clinical trials of the cancer stem cell vaccine on a timely basis or at all, including the need to successfully complete required animal toxicity studies; the risks associated with adhering to projected preclinical or clinical timelines and the uncertainties of outcomes of development work for product candidates, including those based on destroying cancer stem cells as a potentially safe and effective treatment for various cancers; and the risk of obtaining patent coverage for the dendritic cell-based vaccine or cancer stem cell vaccine or that any patents covering those vaccines will provide commercially significant protection for these technologies. Additional risks and uncertainties are described in IMUC's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K. IMUC undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact: For ImmunoCellular Therapeutics, Ltd.
Gary Nash, 212-732-4300
Posted: May 2011