Thursday, 1 November 2012

ImmunoCellular provides update, optimism over cancer vaccine development boosts shares

ImmunoCellular Therapeutics, Ltd. (NYSE MKT:IMUC) Thursday gave an update on year-to-date achievements and anticipated milestones, after closing a follow-on financing for $19.3 million in cash earlier this month.
Shares rose nearly four per cent as at about 10:40 a.m. EDT, trading at$1.86.
The company said its progress in the third quarter and year to date has resulted in “strong fundamentals”. 
“This month, we completed a significant underwritten public financing, which provided approximately $19.3 million of cash, net of commissions and expenses, achieving our goal of capitalizing the company with sufficient cash runway to enable us to achieve our near-term objectives,” said ImmunoCellular interim CEO John S. Yu, MD.
“We have an innovative proprietary technology platform and a growing pipeline of valuable clinical assets. 
“Our development programs are on track and advancing toward anticipated inflection points.” 
Yu said the company anticipates achieving “important upcoming clinical milestones” in the remainder of 2012 and in 2013 that can strengthen its position as “an emerging leader” in cancer immunotherapy.
“Our phase IIb randomized, placebo-controlled, double-blind clinical trial of ICT-107, a dendritic cell vaccine targeting brain tumor antigens and cancer stem cells, is progressing well.”
The company completed enrollment of 278 patients on time, and said the ICT-107 trial is being conducted at 25 clinical sites in the U.S. 
In early 2013, ImmunoCellular said it anticipates that the Data Safety Monitoring Committee will conduct an event-driven interim safety analysis, and that final results will be available in late 2013. 
Rather than simply targeting a single tumor-specific antigen, the company's vaccine pursues multiple different antigens found on cancer stem cells.
The primary endpoint of this trial is overall survival, with secondary endpoints of progression-free survival, overall survival and progression free survival at various time intervals, immune response in T cells and safety. The company has said previously that depending on the trial's progress, results could be available sometime in the late second half of 2013.
Phase I ICT-107 data was “prominently featured” at the Society for Immunotherapy of Cancer annual meeting last month, and in SITC’s press briefing, as an “exciting new breakthrough” in cancer treatment, said ImmunoCellular.
Going forward, the company said it is “on track” to file an investigational new drug (IND) application for ICT-140, a dendritic cell vaccine targeting ovarian cancer antigens and cancer stem cells, at the end of 2012.
It is also planning to initiate a 20-patient, investigator-sponsored phase I trial of ICT-121, a dendritic cell vaccine targeting patients with recurrent brain tumors, also before the end of 2012.
On November 17, ImmunoCellular said it will report at the 17th annual meeting of the Society for Neuro-Oncology on the “Identification of immunogenic epitopes from CD133 and their potential for use to immunologically target glioblastoma cancer stem cells”.
Preclinical data supporting the ICT-121 clinical trial, which targets cancer stem cells in patients with recurrent brain tumors, will be reported.
“In addition, I am pleased to report that we are making significant progress in recruiting a permanent chief executive officer for our company, said Yu.
“We believe that ImmunoCellular has a bright future, and that our pipeline of innovative cancer immunotherapeutics has the potential to offer significant medical benefit to patients.” 
Yu said the company will remain focused on serving the needs and creating value for all its stakeholders, and to making a “significant contribution” to advancing the understanding and treatment of cancer.
ImmunoCellular Therapeutics is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. 

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