ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) provided an update on recent 2012 achievements and anticipated milestones following the closing of its follow-on financing.
Commented John S. Yu, MD, Interim Chief Executive Officer: “We are pleased with our progress in the third quarter of 2012 and year to date. Our fundamentals are strong. 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. 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. We anticipate achieving important upcoming clinical milestones in the remainder of 2012 and in 2013 that can strengthen ImmunoCellular’s 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 glioblastoma antigens and cancer stem cells, is progressing well. We completed enrollment of 278 patients on time, and that trial is being conducted at 25 clinical sites in the US. In early 2013, we anticipate that the Data Safety Monitoring Committee will conduct an event-driven interim safety analysis, and that final results will be available in late 2013. The primary endpoint of this trial is overall survival (OS), with secondary endpoints of progression-free survival (PFS), OS and PFS at various time intervals, immune response (T cells) and safety.
- We are 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.
- We are planning to initiate a 20-patient, investigator-sponsored Phase I trial of ICT-121, a dendritic cell vaccine targeting CD133, in patients with recurrent glioblastoma, also before the end of 2012.
- We are also pleased that ImmunoCellular’s Phase I ICT-107 data were prominently featured at the Society for Immunotherapy of Cancer (SITC) annual meeting, held October 26-28, and in SITC’s press briefing, as an exciting new breakthrough in cancer treatment.
- On November 17, we will report at the seventeenth 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 glioblastoma, 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. It has been my great pleasure to serve as the interim CEO, and to have the opportunity to solidify our accomplishments and aggressively move our company forward. 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. We remain focused on serving the needs and creating value for all our stakeholders, and to making a significant contribution to advancing the understanding and treatment of cancer.”