ImmunoCellular receives FDA IND clearance for ICT-121 Phase I trial in glioblastoma multiforme
Published on July 26, 2012 at 1:13 AM
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."
ImmunoCellular Therapeutics, Ltd.