Lineage Cell Therapeutics Proudly Supports Patients’ Access to Innovative Cell Therapy Treatments & Research Through Passag...
November 13 2020 - 8:30AM
Business Wire
Voters Authorize California Institute
for Regenerative Medicine to Fund $5.5 Billion in Grants for Stem
Cell Research and Development
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing novel cell
therapies for unmet medical needs, strongly endorses the recent
passing of Proposition 14 in California. This bill will enhance
patients’ access to groundbreaking stem cell therapy treatments by
authorizing the California Institute for Regenerative Medicine
(CIRM) the ability to fund up to $5.5 billion in grants to support
therapeutic development, medical research, and facilities based on
stem cell technologies. This initiative builds upon the success of
Proposition 71, which issued approximately $3 billion for the
funding of stem cell research and led to important medical
advances, including functional cures in some patients receiving
cell therapy treatments. The development of Lineage’s OPC1
oligodendrocyte progenitor cell therapy for the treatment of acute
spinal cord injury (SCI), was one of the first clinical trials
supported by CIRM and has showed durable and encouraging results in
some patients.
“At Lineage, the patients and their families inspire us to
advance cell therapy products and this recent approval of
Proposition 14 ensures that access to cutting edge cell-based
therapies can continue from companies like ours,” stated Brian M.
Culley, Lineage CEO. “Cell therapy has the ability to make a
profound impact on millions of lives and the passage of Proposition
14 reflects California’s serious commitment to supporting
innovative local companies through the expensive and time-consuming
process required to discover and test new cell-based therapies and
will drive further innovation in stem cell development and
research. Of note, our clinical study of OPC1 for the treatment of
acute spinal cord injury was one of the first cell therapy clinical
trials supported by CIRM under Prop 71. It was tremendously
meaningful for some of our patients’ success stories to be featured
in the Prop 14 campaign this year, along with others who have
experienced life-changing benefits from stem cell therapy
innovation in California. We are extremely thankful to CIRM for
their partnership and valuable contributions, not only to Lineage,
but also for other companies working in this exciting and rapidly
growing field. We believe that all three of our clinical-stage
programs could be considered for future grant funding under this
new initiative.”
About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant
therapy designed to provide clinically meaningful improvements to
motor recovery in individuals with acute spinal cord injuries
(SCI). OPCs are naturally occurring precursors to the cells which
provide electrical insulation for nerve axons in the form of a
myelin sheath. SCI occurs when the spinal cord is subjected to a
severe crush or contusion injury and typically results in severe
functional impairment, including limb paralysis, aberrant pain
signaling, and loss of bladder control and other body functions.
There are approximately 18,000 new spinal cord injuries annually in
the U.S. and there currently are no FDA-approved drugs specifically
for the treatment of SCI. The OPC1 program has been partially
funded by a $14.3 million grant from the California Institute for
Regenerative Medicine. OPC1 has received Regenerative Medicine
Advanced Therapy (RMAT) designation and Orphan Drug designation
from the U.S. Food and Drug Administration (FDA).
About the OPC1 Clinical Study
The SCiStar Study of OPC1 is an open-label, 25-patient,
single-arm trial testing three sequential escalating doses of OPC1
which was administered 21 to 42 days post-injury, at up to 20
million OPC1 cells in patients with subacute motor complete (AIS-A
or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI).
These individuals had experienced severe paralysis of the upper and
lower limbs. The primary endpoint in the SCiStar study was safety
as assessed by the frequency and severity of adverse events related
to OPC1, the injection procedure, and immunosuppression with
short-term, low-dose tacrolimus. Secondary outcome measures
included neurological functions measured by upper extremity motor
scores (UEMS) and motor level on International Standards for
Neurological Classification of Spinal Cord Injury (ISNCSCI)
examinations through 365 days post-treatment. Enrollment is
complete in this study; patients will continue to be evaluated on a
long-term basis.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology
company developing novel cell therapies for unmet medical needs.
Lineage’s programs are based on its robust proprietary cell-based
therapy platform and associated in-house development and
manufacturing capabilities. With this platform Lineage develops and
manufactures specialized, terminally differentiated human cells
from its pluripotent and progenitor cell starting materials. These
differentiated cells are developed to either replace or support
cells that are dysfunctional or absent due to degenerative disease
or traumatic injury or administered as a means of helping the body
mount an effective immune response to cancer. Lineage’s clinical
programs are in markets with billion dollar opportunities and
include three allogeneic (“off-the-shelf”) product candidates: (i)
OpRegen®, a retinal pigment epithelium transplant therapy in Phase
1/2a development for the treatment of dry age-related macular
degeneration, a leading cause of blindness in the developed world;
(ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a
development for the treatment of acute spinal cord injuries; and
(iii) VAC, an allogeneic dendritic cell therapy platform for
immuno-oncology and infectious disease, currently in clinical
development for the treatment of non-small cell lung cancer. For
more information, please visit www.lineagecell.com or follow the
Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements
of historical facts, contained in this press release, are
forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,”
“could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,”
“contemplate,” project,” “target,” “tend to,” or the negative
version of these words and similar expressions. Such statements
include, but are not limited to, statements relating to Lineage’s
expected eligibility for grants. Forward-looking statements involve
known and unknown risks, uncertainties and other factors that may
cause Lineage’s actual results, performance or achievements to be
materially different from future results, performance or
achievements expressed or implied by the forward-looking statements
in this press release, including risks and uncertainties inherent
in Lineage’s business and other risks in Lineage’s filings with the
Securities and Exchange Commission (the SEC). Lineage’s
forward-looking statements are based upon its current expectations
and involve assumptions that may never materialize or may prove to
be incorrect. All forward-looking statements are expressly
qualified in their entirety by these cautionary statements. Further
information regarding these and other risks is included under the
heading “Risk Factors” in Lineage’s periodic reports with the SEC,
including Lineage’s Annual Report on Form 10-K filed with the SEC
on March 12, 2020 and its other reports, which are available from
the SEC’s website. You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date on
which they were made. Lineage undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20201113005202/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963 Solebury Trout IR
Gitanjali Jain Ogawa (Gogawa@troutgroup.com) (646) 378-2949
Russo Partners – Media Relations Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com David.schull@russopartnersllc.com
(212) 845-4242
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