ImmunoCellular Therapeutics' Cancer Vaccine: Safety and Preliminary Efficacy Results for Glioblastoma Trial Presented at American Academy of Neurology Annual Meeting
LOS ANGELES--(BUSINESS WIRE)--Apr 15, 2011 - ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), announced that Surasak Phuphanich, MD, Principal Investigator of the Phase I clinical trial of ImmunoCellular's lead dendritic cell cancer vaccine candidate for glioblastoma multiforme (GBM) presented safety and preliminary efficacy data yesterday at the American Academy of Neurology (AAN) 63rd Annual Meeting. Dr. Phuphanich, Director of the Neuro-Oncology Program in the Departments of Neurosurgery and Neurology and Professor of Medicine at Cedars-Sinai Medical Center, reported that of 16 newly-diagnosed patients with GBM enrolled between May 2007 and November 2009, 11 (69%) are still alive. Furthermore, six (38%) continue to show no tumor progression for more than two years without disease progression. No serious adverse events were reported, and minor side effects have been limited to fatigue, skin rash and pruritis.
Overall two-year survival for patients treated with ICT-107 was 80%, compared to historical rates for overall survival on standard treatment of 26% in all GBM and 38% in GBM patients whose tumor is completely resected (Stupp et al, NEJM 2005). Median overall survival has not yet been reached. Median Progression-Free Survival (PFS) for patients receiving the cancer vaccine was 16.9 months, comparing favorably with historical PFS of 6.9 months for patients receiving standard treatment, and two-year PFS for vaccine-treated patients was 44%.
“These data demonstrate that our dendritic cell vaccine, ICT-107, which was designed to target both cancer cells and cancer stem cells, has the potential to significantly delay disease recurrence, and thus increase survival in GBM,” said Manish Singh, Ph.D., President and CEO of ImmunoCellular Therapeutics. “Glioblastoma is a devastating cancer, with two-year progression-free-survival rate of approximately 11%. Our safety and preliminary efficacy data provided the basis for our Phase II trial of ICT-107 for GBM, which is now enrolling patients.”
The vaccine is made by taking dendritic cells obtained from the patient's own (autologous) blood, and mixing them with certain manufactured proteins known to be present on cancer cells and cancer stem cells. Patients underwent three vaccinations, along with follow-up clinic visits to check their status, after they had received the standard treatment of surgery, radiation and chemotherapy.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. In February 2011 the Company announced that it had begun enrollment in a multicenter Phase II clinical trial of lead cancer vaccine candidate ICT-107 for the treatment of glioblastoma multiforme (GBM). To learn more about IMUC, please visit www.imuc.com.
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: ImmunoCellular Therapeutics, Ltd.
James Young, 212-732-4300
Posted: April 2011