ImmunoCellular, www.imuc.com – the clinical-stage biotech firm developing therapies for brain and other cancers which focus on utilizing the body’s own immunological system, reported contracting with clinical research organization Averion International Corp. today for the purposes of conducting a planned Phase II study of the Company’s leading cancer-vaccine candidate ICT-107 for GBM (glioblastoma multiforme).
President and CEO of IMUC, Manish Singh, Ph.D., highlighted Averion’s globally recognized reputation as a leader with vast experience in brain cancer, and characterized the selection as ideal for taking ICT-107, the dendritic cell-based vaccine which targets multiple tumor-associated antigens for GBM (and which recently completed Phase I), into Phase II.
Singh projects a Q4 start date this year for Phase II, and indicated that the Company is working hand-in-hand with regulatory and clinical experts to design a study which will present the most rigorous investigation of ICT-107’s extremely promising potential.
Founding member and President of Averion’s Oncology Business Unit, Gene Resnick, M.D., expressed his pleasure at the collaboration with IMUC in advancing the GBM candidate, and noted how relentlessly progressive this form of brain cancer is and how urgent the need for safe and effective treatments.
Resnick spoke of how nicely each company’s expertise in oncology compliments the other, and suggested that the shared vision of “transforming medical innovations into improvements in healthcare” constitutes a viable framework for future efforts.
Averion will be handling enrollment and execution of the double-blind, placebo-controlled study, to be conducted at a 1:1 randomization rate, which will utilize some 100 newly diagnosed GBM patients at some 15 different sites in the US and Canada, with help from neuro-oncology experts and opinion leaders from throughout the field.
As mentioned, the study should kick-off in Q4 this year and projections indicate that it will wrap up within a year after initiation.
This is very good news both for oncology and GBM suffers, and stands to become a driving force for IMUC in the market, leading not only to greater fame for the Company as a developer of leading oncology treatments, but also potential prosperity for IMUC and its shareholders.
Let us hear your thoughts below:
