LOS ANGELES, Aug. 21, 2015 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today issued
the following letter to shareholders.
To Our Shareholders:
As we work toward building a leading cancer immunotherapy
company, the management and board of directors of ImmunoCellular
would like to thank you for your ongoing support of our programs
and strategies. Our intention in this brief communication is not to
address the vagaries of the stock market, over which we have no
control. Rather, we would like to highlight the progress we are
making as ICT-107 advances toward initiation of a registrational
phase 3 trial in newly diagnosed glioblastoma and we build the
Stem-to-T cell platform to create our future pipeline.
- ICT-107 is advancing to its final stage of development.
Reaching agreement with the FDA on the Special Protocol Assessment
is a significant achievement and means we have lower regulatory
risk than completing phase 3 without this up-front FDA
review. To our knowledge, ICT-107 will be the only therapy
currently in phase 3 testing for newly diagnosed glioblastoma with
this advantage.
- Since our oral presentation at ASCO in 2014, in which our
analysis of the phase 2 results identified the patient population
that appears to benefit from ICT-107, management has delivered on a
set of critical milestones in the areas of regulatory,
manufacturing, trial design and trial execution.
- We are positioned to initiate clinical trial sites within 3
months in the US, with plans to enroll the first patient in the
trial soon thereafter.
In addition to advancing the ICT-107 program, we are
establishing a research capability based on our Stem-to-T cell
platform, which originated at Caltech.
- Achieving T cell killing of tumors based on an engineered stem
cell therapy has potential advantages over T cell cancer
immunotherapy approaches.
- We are working to establish key research collaborations with
experts in the field to obtain pre-clinical proof of concept for
this platform technology.
- While ICT-107 advances through phase 3, we intend to generate a
pipeline of programs from this exciting technology and potentially
from other adjacent technologies we are evaluating for in-license
or acquisition.
In the future, we plan to continue to communicate our
achievements, and will look forward to announcing the start of the
phase 3 program. We also are working to evaluate options for
continued financing of the phase 3 trial. Finally, our Board,
focused on identifying and appointing qualified candidates, intends
to remedy our non-compliance with the NYSE policies on the
proportion of independent board members and the constitution of our
Audit Committee.
We cannot control external market conditions or the volatility
of the stock market. We are endeavoring to bring a potential
clinically meaningful treatment to patients in need and, in doing
so, seeking to build shareholder value. That is what we are working
to achieve every day.
Sincerely,
Andrew Gengos
President and Chief Executive Officer
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 has concluded a phase 2 trial of its
lead product candidate, ICT-107, a dendritic cell-based
immunotherapy targeting multiple tumor-associated antigens on
glioblastoma stem cells. ImmunoCellular's pipeline also includes:
ICT-121, a dendritic cell immunotherapy targeting the CD133 antigen
on stem cells in recurrent glioblastoma; ICT-140, a dendritic cell
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 the development and
commercialization of ICT-107, initiation of a phase 3 study of
ICT-107, the advancement of the ICT-121 phase 1 trial, the
development of our preclinical Stem-to-T-cell program and our
ability to achieve our other clinical, operational and financial
goals. These statements are based on ImmunoCellular's current
expectations and involve significant risks and uncertainties,
including those described under the heading "Risk Factors" 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.