LOS ANGELES--(BUSINESS WIRE)-- ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies (the “Company”), today announced that it has contracted with the clinical research organization (CRO) Averion International Corp. to conduct its planned Phase II study of ICT-107, the Company’s lead cancer-vaccine candidate for the treatment of glioblastoma multiforme (GBM).
Averion International is a Southborough, Mass.-based CRO with proven expertise in supporting global clinical trials for pharmaceutical, biotechnology and medical device companies. Averion has significant oncology experience across varied treatment modalities, including approved and investigational agents in brain cancer.
Averion will oversee the enrollment and execution of ImmunoCellular Therapeutics’ planned double-blind, placebo-controlled, 1:1 randomized Phase II study of ICT-107 in approximately 100 patients with newly diagnosed GBM. The study will be conducted in approximately 15 clinical trial centers in the U.S. and Canada in collaboration with leading experts and opinion leaders in neuro-oncology. Enrollment of patients is expected to begin in Q4 2010 and is anticipated by the Company to be completed approximately 12 months after initiation.
“Averion’s globally recognized reputation and extensive experience in brain cancer make it an ideal partner for us as we prepare to initiate our Phase II GBM study in the fourth quarter of this year,” said Manish Singh, Ph.D., president and CEO of ImmunoCellular Therapeutics. “We are working with leading regulatory and clinical experts on a study design that will allow us to continue rigorously investigating the significant promise of ICT-107.”
Gene Resnick, M.D., President of Averion’s Oncology Business Unit and an Averion founder, commented, “We are pleased to be collaborating with ImmunoCellular Therapeutics on its planned Phase II study. GBM is a relentlessly progressive form of brain cancer for which safe and effective new treatments are urgently needed. ImmunoCellular’s dedication to developing innovative cancer therapeutics complements our own expertise in oncology, as well as our vision of transforming medical innovations into improvements in healthcare.”
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 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.
About Averion International
Averion International Corp. is a full-service international clinical research organization (CRO) with proven expertise in supporting global clinical trials for pharmaceutical, biotechnology and medical device companies. The Company has a therapeutic focus in oncology, cardiovascular diseases and medical devices. Averion’s core competencies are in FDA and product registration support, site selection, project management, medical and site monitoring, data management, biometrics, pharmacovigilance, medical writing, and full clinical trial management services throughout the clinical trials lifecycle. The Company has supported over 60 FDA approvals representing products and medical device filings including PMAs, BLAs, and NDAs.
Averion International, Trio Clinical Research, Fulcrum Pharma and ClinResearch/ADDPLAN have been merged into a new global biopharmaceutical and medical device development services organization. The merger, led by a group of investors including The Halifax Group, SV Life Sciences and the Comvest Group is part of a strategy to address the constant pressures and challenges currently facing the pharmaceutical, biotech, and medical device industry through a more unique service offering. Averion is headquartered in Southborough, Mass., with European operations based in Basel, Switzerland. Averion has additional U.S. offices in California, Maryland and New York; and additional offices outside the U.S. in France, the Netherlands, the United Kingdom, Poland, Czech Republic, Russia, Israel, Germany, Austria, and Ukraine. We have additional operation centers in Slovakia and Hungary, and research partnerships in India, Asia and South America. For more information, visit www.averionintl.com.
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including without limitation 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.
Gary Nash, 212-732-4300
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