Study Achieves Progression-free Survival
Endpoint with Statistical Significance; Primary Endpoint of Overall
Survival Not Statistically Significant
Conference Call Today at 5:00 pm ET/2:00 pm
PT
ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE
MKT:IMUC) announced that ICT-107, its dendritic cell-based vaccine,
demonstrated a statistically significant increase in
progression-free survival (PFS) in patients with newly diagnosed
glioblastoma multiforme (GBM) in its randomized, placebo-controlled
phase II trial. A comparison of PFS between ICT-107 and placebo
showed a statistically significant difference in the Kaplan-Meier
(K-M) curves favoring ICT-107 (p=0.014 two-sided, hazard ratio
(HR)=0.56) in the intent-to-treat population of all 124 randomized
patients. The difference in the median progression-free survival
times between ICT-107 and placebo favored ICT-107 and was two
months in duration. For the per-protocol population (117 of 124
patients receiving at least four induction vaccinations), the K-M
comparison p-value improved in treated patients to 0.0074 two-sided
(HR=0.53) and the difference in median progression-free survival
times increased to three months in favor of ICT-107.
The differences in the overall survival (OS) K-M curves did not
reach statistical significance in the intent-to-treat population
(the primary endpoint) or the per-protocol population, with
p-values and HRs of p=0.58 two-sided, HR=0.87, and p=0.40
two-sided, HR=0.79, respectively. However, there were numerical
differences in the median survivals favoring ICT-107 of two months
in the intent-to-treat population and three months in the
per-protocol population.
The OS analysis includes data on 67 events (patient deaths) out
of a possible 124, whereas the PFS analysis includes data from 103
events. ImmunoCellular Therapeutics plans to continue following
patients in this trial to collect more mature OS data. In the
matured data from the open label, phase I trial, the Company
observed a consistent benefit in both PFS and OS compared with
historical controls, and on this basis thinks that it is possible
that the primary OS benefit could be clarified as the phase II data
mature.
In this phase II study, ICT-107 was generally safe and well
tolerated, with no imbalance of adverse events between the active
and placebo groups.
GBM is the most common and aggressive primary cancer of the
brain. Patients with this disease have few therapeutic options;
temozolomide is currently the only FDA-approved systemic
chemotherapy for newly diagnosed GBM.
Patrick Wen, MD, Director of the Center for Neuro-Oncology at
The Dana Farber Cancer Institute and Professor of Neurology at
Harvard Medical School, and an investigator on this trial, said,
“The progression-free survival data look promising in this study.
To my knowledge, this is the first time a placebo-controlled
immunotherapy trial in glioblastoma has demonstrated a
statistically significant improvement in a clinically relevant
measure, such as progression-free survival. We await additional
data to evaluate the effect on overall survival.”
John Yu, MD, Founder, Chairman and Chief Scientific Officer of
ImmunoCellular Therapeutics, said, “We are quite pleased to see
such a strongly statistically significant result in PFS in this
exploratory trial, and believe that in conjunction with the
indications of a survival benefit, these results provide a strong
medical rationale for continued development of ICT-107 as a
potential treatment for glioblastoma. We look forward to discussing
this important clinical outcome, and what next steps, including a
phase III trial, might entail, with the FDA in an end-of-phase-II
meeting.”
Andrew Gengos, ImmunoCellular Therapeutics Chief Executive
Officer, said, “Although we missed the primary OS endpoint, it is
encouraging that the OS and PFS results are consistent and that
most of the predefined secondary endpoints in the OS subgroups
numerically favor ICT-107 over placebo, although none has reached
statistical significance. These phase II results, in conjunction
with the phase I results which have indicated the potential for
long-term survival, support our view that ICT-107 has a biological
and clinically relevant effect in GBM, and potentially may provide
a long-term survival benefit. We plan to analyze the results
further in the coming weeks and learn more with the goal of
informing our next development and regulatory steps. We want to
thank the patients who participated in this trial, and our trial
site collaborators and dedicated clinical team for their high
quality work.”
ImmunoCellular anticipates presenting the results of the ICT-107
phase II trial at an upcoming national scientific or medical
forum.
About the ICT-107 Phase II
Trial
The ICT-107 phase II trial is a randomized, double-blind,
placebo-controlled phase II study of the safety and efficacy of
ICT-107 in newly diagnosed patients with glioblastoma multiforme
following resection and chemoradiation. ICT-107 is an intradermally
administered autologous vaccine consisting of the patient’s
dendritic cells pulsed with six synthetic tumor-associated
antigens: AIM-2, MAGE-1, TRP-2, gp100, HER-2, IL-13Rα2. The control
consists of the patient’s unpulsed dendritic cells.
A total of 124 patients were randomized at 25 clinical trial
sites in the US. One third of the patients or 43 patients were
treated with placebo (their own dendritic cells not exposed to
antigen), and the treatment arm included two thirds or 81 patients
who received the ICT-107 vaccine. All patients in the trial
received standard-of-care temozolamide. The regimen is four
induction doses of ICT-107 after chemoradiation, and then
maintenance doses until the patient progresses. The primary
endpoint of the trial is OS, defined as the time from randomization
until date or death or the last date the patient is known to be
alive. Secondary endpoints include PFS, defined as the time from
randomization until the date of documented progressive disease or
death, whichever occurs first, or the last date the patient is
known to be alive and progression-free if progression or death is
not observed. Other secondary endpoints include the rates of OS and
PFS at six months after surgery, then assessed every three months
until the end of the study. Safety and immune response are
additional secondary endpoints. The phase II trial is powered at
80% to show a nine-month overall survival benefit assessed after
reaching 64 events.
Patients who have not yet progressed will continue in the trial
until an appropriate termination point can be determined.
For patient related information about the ICT-107 clinical
program in glioblastoma (brain cancer), please visit the
ImmunoCellular website at www.imuc.com and access the ICT-107
“Frequently Asked Questions.” The email address to contact the
company directly is clintrials@imuc.com.
Conference Call Today
ImmunoCellular is holding a conference call and webcast today at
5:00 pm ET to discuss the ICT-107 phase II results. The call will
be hosted by Andrew Gengos, President and CEO.
LIVE CALL: (877) 853-5636 (toll-free)
Conference code: 23984187 REPLAY: (855) 859-2056 (toll-free)
(404) 537-3406 Conference code: 23984187
(Replay available from Wednesday, December
11, 2013 at 8:00 pm ET until Tuesday, December 17, 2013 at 11:59 pm
ET.)
The conference call will contain forward-looking statements.
Interested parties who wish to listen to the webcast should visit
the Investor Relations, Events & Presentations section of
ImmunoCellular's website at www.imuc.com. The information provided
on the teleconference and webcast is accurate only at the time of
the conference call, and ImmunoCellular will take no responsibility
for providing updated information except as required by law.
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. ImmunoCellular is
conducting a phase II trial of its lead product candidate, ICT-107,
a dendritic cell-based vaccine targeting multiple tumor-associated
antigens for glioblastoma. ImmunoCellular’s pipeline also includes
ICT-121, a dendritic cell vaccine targeting CD133, and ICT-140, a
dendritic cell vaccine targeting ovarian cancer antigens and cancer
stem 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
that are subject to a number of risks and uncertainties, including
the risk that ICT-107 can be further successfully developed or
commercialized, the outcome of the post-phase II meeting with the
FDA and whether further studies may confirm the successful PFS
results to date. Additional risks and uncertainties are described
in IMUC’s most recently filed quarterly report on Form 10-Q and
annual report on Form 10-K. Except as permitted by law, IMUC
undertakes no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise. In this press release, you can identify
forward-looking statements by terms such as “may,” “will,”
“should,” “could,” “would,” “expect,” “plan,” “anticipate,”
“believe,” “estimate,” “project,” “predict,” “potential,” “future,”
“intend,” “certain,” and similar expressions intended to identify
forward-looking statements. You can identify forward-looking
statements by terms such as “may,” “will,” “should,” “could,”
“would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,”
“project,” “predict,” “potential,” “future,” “intend,” “certain,”
and similar expressions intended to identify forward-looking
statements.
ImmunoCellular Therapeutics, Ltd.Investor RelationsJane
Green415.348.0010 direct415.652.4819 mobilejane@jmgcomm.com
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