ImmunoCellular Therapeutics' ICT-107 Demonstrates 80 Percent Survival at 2 Years in Phase I Study of Newly Diagnosed Glioblastoma Patients
Data to Be Presented at Annual Meeting of American Society of Clinical Oncology
Wednesday June 2, 2010 8:00 am ET
LOS ANGELES, CA -- (BUSINESS WIRE) -- ImmunoCellular Therapeutics, Ltd. (OTC.BB: IMUC ) , a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that data from a recent clinical trial of ICT-107, the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 4-8 in Chicago. The presentation, "Immune response correlation with progression-free survival in glioblastoma following dendritic cell immunotherapy (ICT-107)," features data showing ICT-107 provided a significant increase in survival in patients who received the vaccine.
In the Phase I clinical study of ICT-107 in GBM, newly diagnosed patients who received the vaccine in addition to the standard of care of surgery, radiation and chemotherapy demonstrated a one year overall survival of 100 percent and a two year survival of 80 percent. This compares favorably with historical 61.1 percent one-year and 26.5 percent two-year survival based on the standard of care alone. The median overall survival has not yet been reached at the 26.4 months analysis point, with 12 out of 16 patients alive (75% percent).
The 12-month disease-free survival from the time of surgery was 75 percent with ICT-107, compared with the historical control of 26.9 percent, and the 18-month disease-free survival with ICT-107 was 49.2 percent, compared with 18.4 percent historically. The median progression-free survival (PFS) of 17.7 months after surgery compared especially favorably with the historical median PFS of 6.9 months observed with the standard treatment. Seven of the 16 patients (44 percent) who participated in the study continue to live with no disease progression with an average time of over 29 months. Safety data for ICT-107 also compared favorably to current treatments: no serious adverse events were reported and minor side effects were limited to fatigue, skin rash and pruritis.
"These new data further establish ICT-107 as a promising potential treatment for glioblastoma, a disease for which there are currently few and limited treatment options," said Surasak Phuphanich, M.D., Director of the Neuro-Oncology Program at Cedars-Sinai Medical Center. "We are excited for what these data mean for patients, the medical community, and the field of immunotherapy as a whole. We look forward to further investigating ICT-107 in additional clinical studies."
About ImmunoCellular Therapeutics
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 as well as cancer stem cell antigens for glioblastoma. The Company is planning to initiate a multicenter phase II study in the second half of 2010. In May 2010, ImmunoCellular Therapeutics filed an orphan drug application with the U.S. Food and Drug Administration for ICT-107. The Company's "off the shelf" therapeutic vaccine product candidate (ICT-121) targeting cancer stem cells for multiple cancer indications is targeted by IMUC to enter clinical trials for glioblastoma during the second half of 2010. IMUC has entered into a research and license option deal with the Roche Group for one of the Company's monoclonal antibody product candidates for the diagnosis and treatment of ovarian cancer and multiple myeloma, which provides for potential licensing and milestone payments of $32MM and royalties if the Roche Group exercises its option and commercializes this antibody technology for multiple indications. IMUC is in pre-clinical development of another monoclonal antibody product candidate for the treatment of small cell lung cancer and pancreatic cancer, and is also evaluating its platform technology for monoclonal antibody discovery to target cancer stem cells. 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 risks associated with the potential inability to obtain licenses from third parties that will be needed to commercialize ICT-107 in many major commercial territories; the potential inability to secure a partner for ICT-107; the risk that future trials of ICT-107, if any, do not confirm the safety and efficacy data generated in the Phase I trial; the need to satisfy performance milestones to maintain the vaccine technology licenses with Cedars-Sinai; the risks associated with obtaining a patent that provides commercially significant protection for ICT-107; and the need for substantial additional capital to fund development of product candidates beyond their initial clinical or pre-clinical stages and to continue IMUC's operations. 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.