ImmunoCellular receives FDA IND clearance for ICT-121 Phase I trial in glioblastoma multiforme

ImmunoCellular Therapeutics (NYSE MKT: IMUC) today announced that the U.S. Food and Drug Administration (FDA) has given clearance to a physician sponsored investigative new drug (IND) application to initiate a Phase I clinical trial of ICT-121, IMUC's novel dendritic-cell-based vaccine targeting CD-133, an antigen that is highly expressed by multiple solid tumors.    

The trial, which will be conducted at a leading Los Angeles based medical center, will initially test the vaccine in up to 20 patients with recurrent glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

With a Phase II trial of IMUC's lead product candidate ICT-107 well under way in treating patients with newly diagnosed GBM, ICT-121 is the Company's second dendritic-cell-based vaccine to enter the clinic. Like ICT-107, ICT-121 targets the cancer stem cells (CSCs) that are widely believed to be the root cause of many cancers.

"Preclinical studies conducted by IMUC indicate that ICT-121 effectively targets CD-133, a protein that is over-expressed by a very wide range of solid tumors, including glioblastoma, pancreatic, breast, non-small-cell lung cancer, and several other malignancies associated with poor survival and limited treatment options," said Manish Singh, Ph.D., president and CEO of IMUC. Given the highly encouraging survival benefit we have observed to date in GBM patients treated with ICT-107, we are especially eager to continue evaluating this promising immunotherapeutic approach to cancer treatment with this new study of our second vaccine formulation — initially in recurrent GBM, and eventually in several other tumor types associated with high CD-133 expression."