Breakthrough May Provide Significant Cost Benefits Over Current Manufacturing Methods
LOS ANGELES--(BUSINESS WIRE)-- ImmunoCellular Therapeutics (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that it has developed an innovative method for manufacturing the company’s lead product candidate, ICT-107, a dendritic cell-based vaccine for the treatment of glioblastoma multiforme (GBM). The method was developed in collaboration with the Clinical Cell and Vaccine Production Facility at the University of Pennsylvania.
The new method employs a closed-bag system designed to produce highly potent dendritic cells from white blood cells collected from patients, and for subsequently cryopreserving the dendritic cells for future vaccine treatments. The process has also been optimized to produce high levels of certain cytokines which are correlative of dendritic cells’ ability to boost immune response.
Engineering and validation runs have confirmed that this process may be used to produce 20 or more doses of ICT-107 vaccine from a single blood collection, which may be frozen and later used for vaccination and maintenance of immune response in patients until disease recurrence.
“The validated method we have optimized for producing 20 or more doses of dendritic cell-based vaccine from a single blood collection presents significant cost and convenience advantages over current manufacturing methods, as patients should be able to be treated for several years from a single manufacturing run. For example, Provenge®—another dendritic cell-based vaccine approved for prostate cancer—is manufactured one dose at a time, contributing to its very expensive treatment cost,” said Manish Singh, Ph.D., president and CEO of ImmunoCellular Therapeutics. “We continue to conduct analyses on the significant per-dose manufacturing-cost savings of this new method as we prepare to initiate a Phase II study of ICT-107 in GBM in the fourth quarter of this year.”
About ImmunoCellular Therapeutics, Ltd.
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 recently completed a Phase I trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. The Company is planning to initiate a multicenter Phase II study for this vaccine in late 2010. The Company's "off the shelf" therapeutic vaccine product candidate (ICT-121) targeting cancer stem cells for multiple cancer indications is targeted by IMUC to enter clinical trials during the first half of 2011. To learn more about IMUC, please visit www.imuc.com
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including without limitation the risk that anticipated cost or efficacy improvements from IMUC’s new manufacturing process for ICT-107 will not be realized; the need for substantial additional capital to fund development of product candidates beyond their initial clinical or pre-clinical stages; the risk that the safety and efficacy results obtained in the Phase I trial for ICT-107 will not be confirmed in subsequent trials; the risk that IMUC will not be able to secure a partner company for development or commercialization of ICT-107; the need to satisfy performance milestones to maintain the vaccine technology licenses with Cedars-Sinai; the risks associated with obtaining FDA clearance to commence clinical trials of the cancer stem cell vaccine on a timely basis or at all, including the need to successfully complete required animal toxicity studies; 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; and the risk of obtaining patent coverage for the dendritic cell-based vaccine or cancer stem cell vaccine or that any patents covering those vaccines will provide commercially significant protection for these technologies. Additional risks and uncertainties are described in IMUC's most recently filed SEC documents, such as its most recent annual report on Form 10-K, 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.
ImmunoCellular Therapeutics, Ltd.
Tel: (212) 732-4300
Email: [email protected]
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INDUSTRY KEYWORDS: Stem Cells Health Biotechnology Clinical Trials Hospitals Oncology Pharmaceutical General Health