ImmunoCellular Therapeutics Receives FDA Approval to Commence Phase II Trial of ICT-107
January 04, 2011
LOS ANGELES, CA – January 4, 2011 – ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company that is developing immune-based therapies for the treatment of various forms of cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) amendment to conduct a Phase II clinical trial in the U.S. of ICT-107, the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM).
The double-blind, placebo-controlled, 2:1 randomized Phase II study is designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study will enroll approximately 100 patients and will be conducted at an estimated 15 clinical trial centers in the U.S. in collaboration with leading experts and opinion leaders in neuro-oncology.
"GBM is a highly aggressive disease for which new and better treatments are urgently needed," said Manish Singh, Ph.D. President and CEO. "ICT-107 has demonstrated significant early promise in extending both progression-free and overall survival in patients with GBM, with no serious adverse events reported to date. We look forward to further investigating the therapeutic potential of ICT-107 in a controlled clinical setting."
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 over 30 months analysis point, with 11 out of 16 patients alive (69% 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 24 month disease-free survival with ICT-107 was 43.8 percent, compared with 10.7 percent historically. The median progression-free survival (PFS) of 16.9 months after surgery compared especially favorably with the historical median PFS of 6.9 months observed with the standard treatment. Six of the 16 patients (37 percent) who participated in the study continue to live with no disease progression with an average time of over 30 months. Safety data for ICT-107 also compared favorably to current treatments: no serious adverse events were reported and minor side effects included 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 plans to start patient enrollment in a multi center Phase II study in Q1, 2011. 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 during the first half of 2011. 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 complete the Phase II trial for ICT-107 and to fund development of other 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 ICT-107 will not be confirmed in subsequent trials; the risk of delays in enrolling patients for, or other delays in completing, the Phase II trial for ICT-107; 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; 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.
ImmunoCellular Therapeutics, Ltd.
Tel: (212) 732-4300
Source: ImmunoCellular Therapeutics, Ltd.