Health & Fitness
Health and Fitness
Health and Fitness
Thu, September 9, 2010
Wed, September 8, 2010
ImmunoCellular Therapeutics Announces Long-Term Disease-Free Survival Data from Phase I Study in Glioblastoma
LOS ANGELES--([ BUSINESS WIRE ])--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 Companya™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 thesepatients 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"
aThese data continue to demonstrate the potential of targeting cancer stem cells to significantly delay disease recurrence and thereby increase survival in GBM,a said Manish Singh, Ph.D., president and CEO of ImmunoCellular Therapeutics. aGlioblastoma 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.a
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 studya™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.
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 completed a Phase I trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. The Company is planning to initiate a multicenter PhaseII study in late 2010. The Companya™s aoff the shelfa therapeutic vaccine product candidate (ICT-121) targeting cancer stem cells for multiple cancer indications is targeted by IMUC to enter clinical trials during the first half of 2011. 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 IMUCa™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.
