ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) announced today that the first patient in the phase I clinical trial of ICT-121, a cancer vaccine targeting recurrent glioblastoma multiforme (GBM, or brain cancer), has received the vaccine. ICT-121 is a dendritic cell vaccine targeting CD-133, an important cancer stem cell marker that is commonly expressed on a broad range of solid tumors. The investigator-sponsored phase I trial is being conducted at Cedars-Sinai Medical Center in Los Angeles, CA. ImmunoCellular is supporting the trial by providing the ICT-121 vaccine. “The start of this ICT-121 trial signifies an expansion of our commitment to developing treatments for patients with GBM, and to the continued advancement of our pipeline of dendritic cell-based immunotherapeutic cancer vaccines,” said Andrew Gengos, ImmunoCellular’s Chief Executive Officer. “In 2014 we expect to have three active cancer vaccine clinical programs, led by ICT-107 in newly diagnosed GBM and including ICT-140 in ovarian cancer and ICT-121.” Continued Mr. Gengos: “We are making progress in analyzing the data from the recently completed phase II trial of ICT-107 in newly diagnosed GBM, with the goal of informing our ongoing clinical and regulatory strategies for this program and seeking a meeting with the FDA. We are actively consulting with nationally renowned neuro-oncologists to help establish an objective view of the initial results, and we continue to receive encouragement about the phase II trial from these discussions. They share our view that as the survival data mature in 2014, there is the potential to see clarification of the survival benefit of the ICT-107 treated group. We continue to think that the progression-free survival (PFS) data, which showed a statistically significant advantage of ICT-107 over placebo, represents a meaningful indicator for how the overall survival (OS) data might mature.” Concluded Mr. Gengos: “I want to emphasize some key points relative to ImmunoCellular’s corporate goals and strategies. We intend to build a leading cancer immunotherapy company. We think that our dendritic cell-based cancer vaccine platform has the potential to transform cancer treatment, and that our cancer vaccines in development today could represent new therapeutic options for patients. ICT-107 is the first immunotherapy in a well-designed and placebo-controlled trial to demonstrate safety and a treatment effect in newly diagnosed GBM, a disease for which nothing has been approved in the US since temozolomide in 2005. We urge patients and other stakeholders to look beyond the unsubstantiated commentary on the recent trial results to what we and clinical experts believe are important findings from this clinical program to date. We believe that ICT-107 has notched an important advance in the development of new immunotherapy treatments for GBM, and we are committed to its development. We intend to continue to make high quality, data-driven decisions about advancing and expanding our pipeline, and believe we have sufficient financial resources to meet our near-term goals. We look forward to continuing to meet both the challenges and opportunities inherent in the drug development process.”
About the ICT-121 Phase I TrialThe primary objective of the open label phase I trial is to assess the safety and tolerability of ICT-121. Secondary objectives include overall survival (OS) and progression-free survival (PFS) at six months after surgery as well as other response parameters. Approximately 20 patients who have had gross tumor resection and experience a first recurrence of GBM, and who are HLA-A2 positive, will receive the vaccine in the trial. Patients will be administered the vaccine once per week for four weeks during the induction phase, followed by a maintenance phase consisting of one administration of vaccine every two months until their supply of vaccine is depleted or they experience progressive disease. About ImmunoCellular Therapeutics, Ltd. ImmunoCellular Therapeutics, Ltd. is a Los Angeles area-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. ImmunoCellular is conducting a phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma. ImmunoCellular’s pipeline also includes ICT-121, a dendritic cell vaccine targeting CD133, and ICT-140, a dendritic cell vaccine targeting ovarian cancer antigens and cancer stem cells. To learn more about ImmunoCellular, please visit www.imuc.com. Forward-Looking Statements for ImmunoCellular Therapeutics This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the risk that ICT-107 can be further successfully developed or commercialized, whether the PFS data will continue to favorable results seen in our phase II study or that the survival outcome may change favorably with more data from patients, the outcome of the post-phase II meeting with the FDA and whether our platform technology can be used to develop successful cancer drugs. Additional risks and uncertainties are described in IMUC’s most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Except as permitted by law, IMUC undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In this press release, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential,” “future,” “intend,” “certain,” and similar expressions intended to identify forward-looking statements. You can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential,” “future,” “intend,” “certain,” and similar expressions intended to identify forward-looking statements.