LOS ANGELES, June 5, 2017 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced the presentation of data from the phase 1 clinical trial
of ICT-121 in patients with recurrent glioblastoma. The data from
the 20-patient, open-label, multi-center study show that 6 of 20
patients are alive (as of April 2017;
survival ranging from 10 to 24 months), and these patients will
continue to be followed. As noted in the data presentation, ICT-121
was generally safe and well tolerated. As also noted, although
diversity in patient disease severity resulting from a protocol
amendment to expand patient eligibility makes interpretation of
survival data difficult, the results are encouraging and warrant
further investigation. Pending immune response data will provide
insight into the potential effectiveness of ICT-121 in inducing the
formation of cytotoxic T cells targeting CD133, a cancer stem cell
marker. ICT-121 is a dendritic cell-based immunotherapy that
specifically targets CD133 which is overexpressed in a wide variety
of solid tumors, including glioblastoma as well as non-small cell
lung, colon, ovarian, pancreatic and breast cancers.
The phase 1 data were presented by Jeremy D. Rudnick, MD, a neurologist in the
Johnnie L. Cochran, Jr. Brain Tumor Center in the Department of
Neurology at Cedars-Sinai, in a poster titled, "Immunological
targeting of CD133 in recurrent glioblastoma: A multi-center Phase
I translational and clinical study of autologous CD133 dendritic
cell immunotherapy." The data were presented at the 53rd
Annual Meeting of the American Society of Clinical Oncology (ASCO),
taking place in Chicago.
"The preliminary findings from this phase 1 trial are
encouraging, especially in light of the lethality of recurrent
glioblastoma and lack of therapeutic options for patients with this
disease," said Dr. Rudnick. "We look forward to continuing to
follow the patients in this study, and believe that ICT-121 is a
potentially promising cancer immunotherapeutic agent."
The phase 1 multi-center trial of ICT-121 targeting CD133
assesses safety and tolerability (primary endpoint) and monitors
overall survival and progression-free survival (secondary
endpoints). ICT-121 is comprised of autologous dendritic
cells that are loaded with two HLA-A2 restricted epitopes of the
CD133 antigen. After surgical resection, the HLA-A2-positive
patients with recurrent glioblastoma were treated with ICT-121 once
a week for 4 weeks during the induction phase and then once every 2
months during the maintenance phase until disease progression,
death, ICT-121 depletion or discontinuation. In addition to safety
and survival data, the phase 1 trial also assesses immune response
by using an ELISpot assay and examining cytokine mRNA expression in
response ICT-121 treatment.
"We are encouraged by the preliminary phase 1 results of
ICT-121, which we believe underscore the potential of our DC-based
approach to cancer immunotherapy," said Anthony J. Gringeri, PhD, ImmunoCellular
President and Chief Executive Officer. "We are grateful for the
time and effort of the patients, investigators, and staff who
supported this clinical study."
About Recurrent Glioblastoma and CD-133
A defining characteristic of glioblastoma is the high incidence
of tumor recurrence, which is thought to be triggered by cancer
stem cells. These tumorigenic cells tend to be resistant to
irradiation and chemotherapeutic agents. The target antigen,
CD-133, is overexpressed in glioblastoma tumors and has been
identified as a marker for cancer stem cells. Recent clinical
trials suggest that the short survival time for these patients
emphasizes the important unmet medical need in this disease
requiring additional strategic approaches. Dendritic cell
immunotherapies, such as ICT-121, could provide benefit to patients
by educating their immune systems to induce the formation of
cytotoxic T cells that attack tumor cells bearing the target
antigen. In addition to immediate attack on tumor cells present at
dosing, a long-term memory response effective against tumor
recurrence might be induced. Immunotherapy, such as ICT-121, that
targets cancer stem cells could be an important treatment for this
disease.
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 Company's lead product candidate, ICT-107, is a
patient-specific, dendritic cell-based immunotherapy targeting
glioblastoma and is currently being studied in an international
phase 3 trial. ImmunoCellular's pipeline also includes: ICT-121, a
patient-specific, dendritic cell-based immunotherapy targeting
CD133 found in recurrent glioblastoma; ICT-140, a patient-specific,
dendritic cell-based immunotherapy targeting ovarian cancer; and
the Stem-to-T-cell research program which engineers hematopoietic
stem cells to generate cytotoxic T cells. To learn more about
ImmunoCellular Therapeutics, 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 and
current expectations concerning, among other things, whether
ImmunoCellular will be able to enter into an agreement with a
strategic partner or be able to continue its Phase 3 clinical trial
of ICT-107, and if it continues development of ICT-107, the timing
for enrollment and randomization of patients, the activation of
clinical sites, the receipt and announcement of clinical data; the
development and commercialization of ICT-107; the likelihood,
timing and outcome of ImmunoCellular's evaluation of strategic
alternatives, including a partnership or restructuring;
ImmunoCellular's ability to defend, and the potential outcome of,
the purported securities class action lawsuit; the potential for
further development of ICT-121; the availability of financing; and
ImmunoCellular's ability to achieve its other clinical,
operational, strategic and financial goals. 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 continue to develop ImmunoCellular's product
candidates, the uncertain timing of completion and success of
clinical trials, and the risk that ICT-107 can be further
successfully developed or commercialized. Additional risks and
uncertainties are described under the heading "Risk Factors" in
ImmunoCellular's most recently filed quarterly report on Form 10-K
for the period ended December 31,
2016. 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
415.652.4819
jane@jmgcomm.com
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SOURCE ImmunoCellular Therapeutics, Ltd.