LOS ANGELES, July 25, 2016 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
reported progress in its two lead cancer immunotherapy clinical
programs: the phase 3 registrational trial of ICT-107 for newly
diagnosed glioblastoma and the phase 1 trial of ICT-121 for
recurrent glioblastoma.
In the ICT-107 phase 3 registrational trial, as of July 21, 2016, 109 patients have been screened in
the US and Canada, with plans to
randomize qualifying patients once they have completed standard of
care and are re-screened (patients randomized in the trial are
treated approximately 90 days following initial screening). In
addition, clinical supplies (ICT-107 and placebo) for 12 patients
have been manufactured. ImmunoCellular also reported that 56
clinical sites in the US and two sites in Canada have been activated, representing
almost half the total number of the planned 120 sites for the
trial.
ImmunoCellular has made progress toward initiating patient
recruitment in Europe. The first
clinical sites in Europe are
anticipated to be activated in the third quarter of this year, and
regulatory approval to begin the trial has now been received in the
UK, the Netherlands and
Spain. ImmunoCellular anticipates receiving regulatory
approvals from all eight European countries participating in the
trial in the third quarter of this year. In addition,
ImmunoCellular's European manufacturer, PharmaCell B.V., has
notified it that their process is now qualified to manufacture
ICT-107 under Good Manufacturing Practices (cGMP).
As previously disclosed, in September of 2015, The California
Institute of Regenerative Medicine (CIRM) awarded ImmunoCellular up
to $19.9 million toward financing the
ICT-107 phase 3 trial. This award is distributed to ImmunoCellular
in milestone payments that are primarily dependent on patient
enrollment and randomization. In June
2016, ImmunoCellular amended the terms of its award from
CIRM to (i) increase the project initial payment by $1.5 million, and (ii) reduce the
potential future milestone payments by a corresponding $1.5 million. The potential total amount of
the award from CIRM remains at $19.9 million, inclusive of amounts received
to date. On July 18, 2016,
ImmunoCellular received the $1.5
million payment from CIRM related to the increase in the
project initial payment. To date, ImmunoCellular has received
$5.5 million from CIRM.
ImmunoCellular also reports that the phase 1 open-label trial of
ICT-121 in patients with recurrent glioblastoma has completed
enrollment, reaching the target of 20 patients. The trial is
being conducted at six sites in the US and preliminary results are
expected within the next 12 months.
"I am pleased with the progress ImmunoCellular has made in
implementing our ICT-107 and ICT-121 clinical programs," said
Andrew Gengos, ImmunoCellular Chief
Executive Officer. "We continue to work diligently to advance these
programs, as glioblastoma remains a high unmet medical need for
which new treatments are needed. We appreciate the interest in our
programs from the oncology community and our collaborators."
For patients, families and physicians seeking additional
information about the ICT-107 phase 3 trial, please consult
www.clinicaltrials.gov.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that
is developing immune-based therapies for the treatment of brain and
other cancers. The phase 3 registrational trial of lead product
candidate, ICT-107, a patient-specific, dendritic cell-based
immunotherapy targeting multiple tumor-associated antigens on
glioblastoma stem cells, has been initiated. ImmunoCellular's
pipeline also includes: ICT-121, a patient-specific, dendritic
cell-based immunotherapy targeting the CD133 antigen on cancer stem
cells in recurrent glioblastoma; ICT-140, a patient-specific,
dendritic cell-based immunotherapy targeting antigens on ovarian
cancer stem cells; and the Stem-to-T-cell research program which
engineers the patient's hematopoietic stem cells to generate
antigen-specific cancer-killing T cells. To learn more about
ImmunoCellular, please visit www.imuc.com
Forward-Looking Statements for ImmunoCellular Therapeutics
This press release contains certain forward-looking statements,
including statements regarding ImmunoCellular's intentions or
current expectation concerning, among other things, timing for
enrollment of patients, the activation of clinical sites, amount of
clinical funding and the receipt of regulatory approvals to begin
trials in Europe for its phase 3
registrational trial of ICT-107 for newly diagnosed glioblastoma,
timing for preliminary results from the phase 1 trial of ICT-121 in
patents with recurrent glioblastoma and the potential for eventual
regulatory approval, commercialization and launch of
ImmunoCellular's product candidates. Forward-looking statements are
not guarantees of future performance and are subject to a number of
risks and uncertainties, including the availability of resources to
develop ImmunoCellular's product candidates, the uncertain timing
of completion and success of clinical trials, the risk that ICT-107
can be further successfully developed or commercialized, the timing
for completion of the phase 3 studies, whether the results will
support registration filing with the FDA or EMA and the whether
ImmunoCellular has sufficient resources to complete the phase 3
trial and if successful, file an NDA. Additional risks and
uncertainties are described in ImmunoCellular's most recently filed
quarterly report on Form 10-Q and annual report on Form 10-K.
Except as required by law, ImmunoCellular undertakes no obligation
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Contact:
ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
jane@jmgcomm.com
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SOURCE ImmunoCellular Therapeutics, Ltd.