ImmunoCellular Brings Second Manufacturing Site On-line
April 04 2012 - 8:00AM
Business Wire
ImmunoCellular Therapeutics, Ltd. (“IMUC” or the “Company”)
(OTCBB: IMUC), a clinical-stage biotechnology company that is
focused on developing new immune-based products to treat and
diagnose cancer, announced today that the transfer of technology
from the University of Pennsylvania to a second manufacturing site
is complete. Last October, IMUC entered into an arrangement with
Progenitor Cell Therapy, LLC,(PCT) a wholly owned subsidiary of
NeoStem, Inc. (NYSE AMEX: NBS), to produce ICT-107, a dendritic
cell-based vaccine targeting multiple tumor-associated antigens for
glioblastoma (GBM), for IMUC’s Phase II clinical trial.
Technology was transferred from the University of Pennsylvania
to the second manufacturing site at PCT’s Mountain View, California
facility, and qualification runs demonstrated equivalent processes
and the ability to produce ICT-107 at multiple locations. This will
allow for significantly increased production, and will mitigate
site-specific risks by spreading the manufacturing process to
multiple locations. Most importantly, this will allow more patients
to be treated each week. PCT’s California facility may also be used
to support a Phase III trial as well as the commercialization of
ICT-107, if needed.
“We are pleased to bring our second manufacturing site online,
which will increase our ability to produce ICT-107,” said Manish
Singh, PhD, President and Chief Executive Officer of IMUC. “We
continue to focus on enrolling and dosing patients
efficiently.“
Robert Preti, PhD, President and Chief Scientific Officer of PCT
added, “We're very proud of the successful ICT-107 technology
transfer to PCT, and are excited to provide expertise and
manufacturing support to IMUC for their current and future trials,
as well as any future commercial efforts."
IMUC has 166 patients enrolled in its ongoing Phase II Clinical
Trial of ICT-107 in GBM. The trial expects to enroll about 200
patients in order to treat 102 patients with HLA-A1/A2
immunological subtypes. In the Phase I clinical study of ICT-107 in
GBM, 16 newly diagnosed patients who received the vaccine in
addition to standard of care treatment of surgery, radiation and
chemotherapy demonstrated two-year overall survival of 80 percent
and a three-year overall survival of 55 percent. These figures
compare favorably to the current 26 percent two-year overall
survival and 16 percent three-year overall survival based on the
historical standard of care treatment alone. The median overall
survival was 38.4 months compared to the current 14.6 months for
the historical standard of care treatment. The study's median
progression free survival (PFS) of 16.9 months compared favorably
to the historic median PFS of 6.9 months. Six out of the 16 (37.6%)
newly diagnosed patients who received ICT-107 in the Phase I
Clinical Trial continued to show no tumor recurrence at the last
analysis, with 3 of these patients (18.8%) remaining disease-free
for more than 4 years, while the other 3 patients had gone more
than 3 years disease-free. There have been no serious adverse
treatment related symptoms observed in any of the patients. The
clinical centers currently recruiting for this clinical trial and
enrollment criteria are listed at:
http://clinicaltrials.gov/ct2/show/study/NCT01280552?term=ICt-107&rank=1.
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 recently
commenced a Phase II trial of its lead product candidate, ICT-107,
a dendritic cell-based vaccine targeting multiple tumor-associated
antigens for glioblastoma. To learn more about IMUC, please
visit www.imuc.com.
About NeoStem, Inc.
NeoStem, Inc. ("NeoStem" or the "Company") continues to develop
and build on its core capabilities in cell therapy to capitalize on
the paradigm shift that the Company sees occurring in medicine. In
particular, NeoStem anticipates that cell therapy will have a large
role in the fight against chronic disease and in lessening the
economic burden that these diseases pose to modern society.
NeoStem’s January 2011 acquisition of Progenitor Cell Therapy, LLC
("PCT") provides NeoStem with a foundation in both manufacturing
and regulatory affairs expertise. The Company believes this
expertise, coupled with its existing research capabilities and
collaborations, will allow the Company to achieve our mission of
becoming a premier cell therapy company. NeoStem’s PCT subsidiary's
manufacturing base is one of the few current Good Manufacturing
Practices ("cGMP") facilities available for contracting in the
burgeoning cell therapy industry. For more information on NeoStem,
please visit www.neostem.com.
Forward-Looking Statements
This press release contains certain forward-looking statements
that are subject to a number of risks and uncertainties, including
the risk that the new manufacturing site may not meet expectations;
the risk that IMUC will not be able to secure a licensee for
development and commercialization of ICT-107 on favorable terms or
at all; the need for substantial additional capital to fund
development of ICT-107 through to commercialization; the risk that
safety and efficacy results for the dendritic cell-based vaccine
will not be confirmed in subsequent trials; the risk that previous
results will not be reflected in statistically significant larger
patient populations; the risks associated with adhering to
projected preclinical or clinical timelines and the uncertainties
of outcomes of development work for product candidates; and the
risk of obtaining patent coverage for the dendritic cell-based
vaccine or that any patents covering this vaccine will provide
commercially significant protection for this product candidate.
Additional risks and uncertainties are described in IMUC's most
recently filed SEC documents, such as its most recent annual report
on Form 10-K, all quarterly reports on Form 10-Q and any current
reports on Form 8-K. IMUC undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
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