Sep 17 2010
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).
“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.”
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."
Source : ImmunoCellular Therapeutics
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