LOS ANGELES, Nov. 14, 2014 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT:IMUC) announces the
presentation today of updated efficacy data from the phase II trial
of dendritic cell-based immunotherapeutic vaccine ICT-107 at the
19th Annual Scientific Meeting and Education Day of the
Society for Neuro-Oncology, being held in Miami, FL. Patrick Y.
Wen, MD, Director of the Center for Neuro-Oncology at Dana
Farber Cancer Institute and Professor of Neurology at Harvard Medical School, and principal investigator
on the trial, will present the maturing data set in patients with
newly diagnosed glioblastoma multiforme (GBM) in an oral
presentation.
Consistent with prior data presentations in December 2013 and June
2014, the results demonstrate a statistically significant
progression-free survival (PFS) benefit, and a numeric overall
survival (OS) benefit in ICT-107 treated patients compared to the
control group. The ICT-107 treatment effect continues to be
strongest in the pre-defined HLA-A2 subgroup of patients in which
the MGMT methylated patients showed the largest treatment effect,
with a significant PFS advantage over the control group, and
continued potential for the OS advantage to move toward
significance as more events occur. There were no differences
in adverse events between the ICT-107 treated group and the control
group.
"ICT-107 continues to hold promise for patients with newly
diagnosed glioblastoma, as no other immunotherapy has shown
statistical benefit for a clinical outcome in a controlled trial in
this patient population," said Dr. Wen. "I think that the data from
the phase II trial strongly support advancing to a registrational
program."
"With this second update of the original trial results, we
remain confident that there is a meaningful treatment benefit in
HLA-A2 patients. In the per-protocol population, OS hazard
ratios are in the 0.6-0.7 range for all HLA-A2 patients as a group
as well as for each of the MGMT subgroups. If our upcoming
phase III program generates statistically significant results in
this range, ICT-107 could represent a clinically meaningful advance
for GBM patients," said Andrew
Gengos, ImmunoCellular's Chief Executive Officer. "The US
FDA and three national European regulators have indicated support
for phase III testing. We anticipate hearing shortly from the
EMA, and then expect to be in position to finalize our phase III
design and move into trial execution in 2015."
Updated ICT-107 Phase II OS and PFS Results
- As of October 2014, a total of 88
events (patient deaths) had been recorded from the 124 randomized
patients, representing 9 additional events since these data from
the phase II trial were last updated in June
2014. There were 25 active and 11 control patients alive for
a total of 36 patients available for additional follow-up.
- Median PFS for the HLA-A2 methylated MGMT per-protocol (PP)
population was 24.1 months for the ICT-107 treated group and 8.5
months for control, representing a statistically significant
15.6-month PFS benefit for the ICT-107 treated group (age
stratified HR = 0.257 [0.095-0.697], p = 0.004).
- Median OS for the HLA-A2 methylated MGMT PP population was 23.9
months for the control group, and the median has not yet been
reached for the ICT-107 treated group. At the time of the analysis,
65% of ICT-107 patients and 50% of the control patients were alive
(age stratified HR = 0.631 [0.212-1.880], p = 0.404), suggesting
the potential for long-term survival with ICT-107 treatment.
- Median PFS for the HLA-A2 unmethylated MGMT PP population was
10.5 months for the ICT-107 treated group and 6.0 months for
the control group, representing a 4.5-month median PFS benefit for
the ICT-107 treated group (age stratified HR = 0.720 [0.351-1.474],
p = 0.364).
- Median OS for the HLA-A2 unmethylated MGMT PP population, was
15.8 months for ICT-107 patients, and 11.8 months for the control
group, representing a 4-month median OS benefit for the
ICT-107 treated group (age stratified HR = 0.652 [0.320-1.325], p =
0.233).
- Median PFS in the intent-to-treat (ITT) population (all phase
II patients) was 11.4 months for the ICT-107 treated group and 10.1
months for the control group, representing a statistically
significant benefit in the ICT-107 treated group (age stratified HR
= 0.640 [0.423-0.968], p = 0.033).
- Median OS in the ITT population was 18.3 months for the ICT-107
treated group and 16.7 for the control group, representing a
numeric, but not statistically significant, advantage for the
treatment group (age stratified HR = 0.854 [0.547-1.334], p =
0.487).
The Company is utilizing all available information from the
controlled phase II trial to design phase III testing in order to
increase its probability of success, including the timing of
randomization within the standard-of-care treatment these patients
receive, in an attempt to limit the number of patients who are
"early progressors" and unlikely to respond to therapy.
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 patients with newly diagnosed glioblastoma multiforme
following resection and chemoradiation. ICT-107 is an intradermally
administered autologous vaccine consisting of the patient's own
dendritic cells pulsed with six synthetic tumor-associated
antigens: AIM-2, MAGE-1, TRP-2, gp100, HER-2, IL-13Rα2. The placebo
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, and the treatment arm included two thirds or
81 patients. All patients in the trial received standard-of-care
temozolomide. 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 of 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.
Both the OS and PFS median results in the ICT-107 phase II trial
were measured from the time of randomization (at the start of
vaccination after standard-of-care surgery and
chemoradiation). In historical studies of newly diagnosed GBM
patients (e.g., Stupp, et al.), OS and PFS measurements were likely
assessed from the time of surgery. In the ICT-107 phase II
trial, there was an average of about 83 days from surgery to
randomization.
The subgroups analyzed in the phase II trial were based on age,
gender, HLA type, MGMT status, performance status and resection
status.
HLA (human leukocyte antigens) are cell-surface
antigen-presenting proteins. These molecules are on dendritic cells
and present the tumor-associated antigens to T-cells to induce the
immune response to the ICT-107 vaccine. HLA-A2 was one of two HLA
types that were treated in the phase II trial. Of the two types,
HLA-A2 is twice as common in the population as HLA-A1, and is the
most common HLA type in North
America and the EU.
HLA-A2 patients comprised about 62% of all patients randomized
in the trial, meaning that these numeric and statistical outcome
benefits were conveyed to a majority of treated patients.
MGMT status has been demonstrated to be predictive of response
to radiation or chemotherapy. The O(6)-methylguanine-DNA
methyltransferase, or MGMT, gene is responsible for a DNA repair
mechanism in cells. Methylation of MGMT impedes the DNA repair
mechanism in cancer cells, making them susceptible to radiation or
chemotherapy, such as temozolomide. The DNA repair mechanism in
cancer cells with unmethylated MGMT is intact, enabling them to
survive and proliferate. 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.
For patient-related information about the ICT-107 clinical
program in glioblastoma, 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.
ImmunoCellular to Host Conference Call on Tuesday, November 18th
ImmunoCellular plans to host a conference call and webcast to
discuss the ICT-107 updated data presented at SNO and other
corporate matters on Tuesday, November 18,
2014, at 5:00 pm EST. The call
will be hosted by Andrew Gengos,
President and CEO.
LIVE CALL:
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(877) 853-5636
(toll-free); international dial-in: (631) 291-4544; conference code
35132957
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WEBCAST:
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Interested parties
who wish to listen to the webcast should visit the Investor
Relations section of ImmunoCellular's website at www.imuc.com,
under the Events and Presentations tab. A replay of the webcast
will be available one hour after the conclusion of the
event.
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The conference call will contain forward-looking statements. The
information provided on the teleconference 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 timing and outcome of the post-phase II meeting
with the FDA and EU regulatory authorities, the status of the
current data and whether further analyses or later studies may
confirm the successful PFS results to date, the potential for
initiation and design of phase III trials and possibility of
successful results from such studies. 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.
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.