LOS ANGELES, CA, June 24, 2009 -- ImmunoCellular Therapeutics, Ltd. (OTC: IMUC.OB ) (IMUC), a biotechnology company, today announced that the company has signed an agreement with Formatech, Inc. for the manufacture of IMUC's cancer stem cell vaccine product candidate, ICT-121, for an upcoming clinical trial. The Phase I clinical trial of ICT-121 will target glioblastoma (brain cancer) and is expected to begin early next year, pending clearance by the FDA. ICT-121 is an "off-the-shelf" product, and this agreement calls for Formatech to prepare the vials of cancer vaccine for the clinical trial under a GMP (Good Manufacturing Practices) environment. ICT-121 is the company's lead product candidate that targets cancer stem cells and may have applicability to multiple types of cancer.
"Immunotherapies are an exciting area of medical research, and we are particularly excited by ICT-121 given that it targets cancer stem cells, an approach which we believe could have a persistent and lasting effect in fighting a patient's cancer," stated Manish Singh, Ph.D., president and chief executive officer of IMUC. "ICT-121 has shown its ability in preclinical studies to target and destroy cancer stem cells present in brain tumors, so we are excited to initiate this trial in the coming months with the ultimate goal of being able to someday offer to patients a safer and more effective treatment alternative than the current standard of care."
About ICT-121
ICT-121 is IMUC's cancer stem cell (CSC) vaccine product candidate that consists of a peptide to stimulate a cytotoxic T-lymphocyte (CTL) response to CD133, which is generally over expressed on the CSCs. It is designed as an "off-the-shelf" vaccine. IMUC will initially evaluate it in a Phase I clinical study for glioblastoma which the company expects to file an Investigational New Drug application (IND) for in the fourth quarter of this year. While glioblastoma will be the initial target for ICT-121, CD133 is also over expressed in colon cancer, breast cancer, liver cancer, prostate cancer, multiple myeloma and melanoma, providing many potential cancer targets for this CSC vaccine in the future.
About ImmunoCellular Therapeutics
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's "off the shelf" therapeutic vaccine product candidate targeting cancer stem cells for multiple cancer indications is expected to enter clinical trials early next year. IMUC is in pre-clinical development of a monoclonal antibody product candidate for the treatment of small cell lung cancer and pancreatic cancer, and is also evaluating its platform technology for monoclonal antibody discovery using differential immunization for diagnosing and treating multiple types of cancer. To learn more about IMUC, please visit www.imuc.com.
Formatech, Inc.
Formatech was founded in 1993 and is based in Andover, MA. The company provides product development and aseptic fill finish manufacturing services to the biopharmaceutical and pharmaceutical industries. In particular, Formatech has significant experience developing formulations for both liquid and lyophilized biotherapeutic products. For more information about Formatech, please visit www.formatech.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including without limitation the risks associated with the timely manufacture of the formulation of the cancer stem cell vaccine for clinical and commercial use and obtaining FDA clearance to commence clinical trials of the cancer stem cell vaccine on a timely basis or at all; the risks associated with adhering to projected preclinical or clinical timelines and the uncertainties of outcomes of development work for product candidates, including those based on destroying cancer stem cells as a potentially safe and effective treatment for various cancers; the need to satisfy performance milestones to maintain the vaccine technology licenses with Cedars-Sinai; the risks associated with generating data to support the provisional patent application for the CSC technology and of obtaining a patent that provides commercially significant protection for this technology; and the need for substantial additional capital to fund development of product candidates beyond their initial clinical or pre-clinical stages. Additional risks and uncertainties are described in IMUC's most recently filed SEC documents, such as its most recent annual report on Form 10-KSB, 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.
Source: ImmunoCellular Therapeutics, Ltd.
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