LOS ANGELES--(BUSINESS WIRE)--ImmunoCellular Therapeutics, Ltd. (OTCBB:IMUC) announced today the commencement of a Phase I clinical trial of its lead brain tumor vaccine product candidate.
The vaccine trial, which is being conducted at the newly dedicated Johnny L. Cochran, Jr. Brain Tumor Center at Cedars-Sinai Medical Center in Los Angeles, is being funded by IMUC and is designed to evaluate safety/toxicity, feasibility and biological activity. The trial should also provide a preliminary indication of whether the vaccine is generating an immune response in patients, one of the necessary preconditions to the vaccine being effective. Approximately 30 patients are expected to be enrolled in the trial, which should take approximately 12 to 18 months to complete.
The IMUC vaccine will be tested in patients who have first been diagnosed or who have suffered a recurrence of glioblastoma. The high rate of mortality of patients diagnosed with brain cancers and in particular glioblastoma multiforme (the most lethal and devastating form), is driving the need to develop new treatments to increase the survival time and enhance the quality of life of patients. Neither surgery, radiation nor anti-cancer drugs, the standard treatment modalities, have been able to meaningfully extend patients’ lives.
The IMUC vaccine is a dendritic cell-based vaccine that could potentially bolster the body’s natural tendency through its immune system to defend itself against malignant brain tumors. Dendritic cells play a central role in the body’s immune response.
Dendritic cell therapy generally involves harvesting dendritic cells from a patient, then culturing and processing them in a laboratory to produce more dendritic cells. The dendritic cells are cultured with specific antigens that are on tumor cells to enable the dendritic cells to recognize cancer cells as targets for attack. When the newly cultured dendritic cells are injected back into the patient, it is hoped that they will seek out the remaining tumor cells and signal the T cells to destroy them.
The IMUC vaccine is based on a proprietary technology that has been exclusively licensed to the company. “We are delighted to be commencing this trial of a new investigational vaccine that has been developed from our findings of earlier clinical trials,” said Dr. John Yu, IMUC’s Chairman of the Board and a co-inventor of the technology, and Co-Director of the Comprehensive Brain Tumor Program, Department of Neurosurgery at Cedars-Sinai. “The scientific community is increasingly focusing on immunotherapies in general and dendritic cell therapies in particular as having the potential to more effectively treat many forms of cancer than other currently available treatment regimens.”
“At Cedars-Sinai, we have developed and tested in patients earlier versions of dendritic cell-based vaccines for treating brain tumors. These preliminary trials demonstrated a safety profile and encouraging, although limited, efficacy results,” said Dr. Keith Black, Chairman of IMUC’s Scientific Advisory Board, the Chairman of the Department of Neurosurgery and Director of the Maxine Dunitz Neurological Institute at Cedars-Sinai and a co-inventor of the IMUC vaccine technology. “We hope that IMUC’s new vaccine will represent a significant improvement over these earlier vaccines. If the current trial is successful, IMUC will conduct a larger, controlled trial with the vaccine that could potentially serve as the pivotal trial for purposes of seeking FDA marketing approval.”
About ImmunoCellular Therapeutics
ICT is a Los Angeles, California based development stage company that will seek to develop cellular therapies for the treatment of brain and other cancers as well as neurodegenerative disorders. ICT’s initial focus will be on a dendritic cell-based vaccine for treating brain tumors, with a Phase I trial for its leading vaccine product candidate having commenced in May 2007.
This press release contains certain “forward-looking statements” (statements as to matters other than historical facts) as defined in the Private Securities Litigation Reform Act and in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events, projections or results described in the forward-looking statements. These risks and uncertainties include without limitation the need to obtain and possible delays in receiving clearance to commence any future clinical trials of IMUC’s lead product candidate and or any future product candidate from the FDA and any medical center involved in the trial; the risk that the FDA will not permit the next trial of IMUC’s lead product candidate following the Phase I trial to serve as a pivotal trial; the need to recruit suitable patients for the Phase I trial and other future clinical trials; the risk of losing the services of senior management personnel; the uncertainty of outcomes for the Phase I trial and other future clinical trials; the need to secure appropriate clinical supplies for the product candidate for future clinical trials; and the need to raise significant additional capital to complete the development of IMUC’s lead product candidate and to conduct pre-clinical work and clinical trials for any future product candidates. Additional risks and uncertainties are described in ICT’s most recently filed SEC documents, such as its most recent annual report on Form 10-KSB, all quarterly reports on Form 10-QSB and any current reports on Form 8-K. ICT 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.
David Wohlberg, President and COO, 310-789-1213
Allen & Associates, LLC
Marcia Allen, 310-820-8730