ImmunoCellular Receives FDA IND Approval for ICT-121 Phase I Trial

ImmunoCellular Therapeutics introduced that the U.S. Food and Drug Administration (FDA) has given clearance in a health practitioner financed investigative new drug (IND) application to actually initiate a Phase I clinical trial of ICT-121, IMUC's novel dendritic-cell-based vaccine focusing on CD-133, an antigen that would be highly mentioned by multiple solid tumors.

The trial, which should be conducted at the leading Los Angeles centered medical center, is likely to initially test the vaccine in as much as 20 affected individuals with regular glioblastoma multiforme (GBM), the commonest and aggressive type of brain cancer.

With the use of a Phase II trial of IMUC's lead product applicant ICT-107 well started by in treating affected individuals with newly diagnosed GBM, ICT-121 is the Organization's second dendritic-cell-based vaccination to get in the clinic. Like ICT-107, ICT-121 targets the cancer stem cells (CSCs) which are widely regarded as the root reason behind many cancers.

"Preclinical studies performed by IMUC implies that ICT-121 efficiently impacts on CD-133, a protein that would be over-expressed by a very wide variety of solid tumors, such as glioblastoma, pancreatic, breast, non-small-cell lung cancer, and several other malignancies linked to poor survival and restricted methods of treatment," said Manish Singh, Ph.D., president and CEO of IMUC.

Offered the highly encouraging existence benefit now we have seen currently in GBM affected individuals treated with ICT-107, we are especially eager to continue evaluating this promising immunotherapeutic approach to cancer treatment using this new consideration of our second vaccine formulation at first in regular GBM, and subsequently in several other tumor kinds linked to high CD-133 expression.