- Use of the Neurgain PDI system could support later-stage
trials of OPC1 in cervical injury patients - OPC1 Investor
& Analyst Day planned for February 22, 2021
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing allogeneic cell
therapies for unmet medical needs, today announced that it has
entered into an exclusive option and license agreement with
Neurgain Technologies, Inc. (“Neurgain”), a medical device company
that is commercializing technology developed by neurosurgeons at
the University of California San Diego (“UC San Diego”). Under the
terms of the agreement, Lineage and Neurgain will collaborate on
the clinical testing of Neurgain’s novel Parenchymal Delivery
Injection (“PDI”) system, which is designed to allow for the
administration of cells to the spinal cord without stopping the
patient’s respiration. Elimination of the need to stop respiration
during surgery is expected to reduce the complexity, risk, and
variability of administering cells to the area of injury. Lineage
also will be hosting an OPC1 Investor and Analyst Day on February
22, 2021 to provide details on recent OPC1 milestones and plans for
2021.
Lineage will evaluate the Neurgain PDI system’s ability to
safely and effectively deliver OPC1, Lineage’s allogeneic
oligodendrocyte progenitor cell (OPC) transplant, to the spinal
cord in both preclinical and clinical studies beginning this year.
If results from the PDI system are positive, then Lineage may
exercise its option to enter into a pre-negotiated license and
commercialization agreement with Neurgain. Pursuant to that
agreement, Lineage may integrate the PDI system into a later-stage
clinical trial and if approved, commercial use of OPC1 for the
treatment of patients with a cervical spinal cord injury. There
currently are no U.S. Food and Drug Administration (“FDA”) approved
treatments for spinal cord injury.
Brian M. Culley, Lineage CEO stated, “Several months ago, we
announced we had significantly improved the process for
manufacturing OPC1, leading to large increases in purity and scale.
More recently, we successfully developed a new 'thaw-and-inject'
formulation, eliminating the commercially undesirable steps of
handling and preparing cells one day prior to their use. Today, we
are announcing another valuable improvement to the OPC1 program:
access to a novel and convenient delivery system, which reduces a
significant technical hurdle of conducting a larger-scale clinical
trial. The Neurgain PDI offers an easier, potentially safer, and
commercially more attractive option to treat SCI patients and is
preferable to the complicated gantry utilized in an earlier study.
It also will allow us to incorporate our new 'thaw-and-inject'
formulation of OPC1, thereby enabling faster patient enrollment via
access to a larger number of clinical trial sites. Most
importantly, the PDI can eliminate the need for a patient’s
respirator to be turned off during the procedure, facilitating a
measured and targeted transplantation of cells to the affected
area.”
“We look forward to collaborating with Lineage on their novel
OPC1 program and demonstrating the value that Neurgain’s PDI system
can provide for the effective delivery of cell therapies in general
and for the treatment of spinal cord injury in particular,” stated
Michael Krupp, Neurgain CEO.
Brian Culley added, “Similar to our alliance with Gyroscope
Therapeutics for the Orbit Subretinal Delivery System, this new
partnership with Neurgain delivers on our stated commitment to
identifying and deploying optimal combinations of allogeneic cell
therapies, modern manufacturing techniques, and superior delivery
solutions in pursuit of our goal of becoming the pre-eminent
allogeneic cell transplant company.”
The Neurgain PDI System has been designed to provide specific,
on-target delivery of cells with accurate dosing. The PDI system is
more compact than existing devices and it is attached directly to
the patient during the procedure. It is comprised of a platform and
manipulator with a disposable magnetic needle assembly. This novel
delivery system is expected to provide a significant improvement in
usability and precision when compared to the methods and tools
utilized to deliver OPC1 cells in the completed phase 1/2a SCiStar
study of OPC1 for the treatment of acute cervical SCI.
About Spinal Cord Injuries
A spinal cord injury (SCI) occurs when the spinal cord is
subjected to a severe crush or contusion and frequently 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. There are no FDA-approved drugs specifically
for the treatment of SCI. The cost of a lifetime of care for a
severe spinal cord injury can be as high as $5 million.
About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant
therapy designed to provide clinically meaningful improvements in
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. The OPC1 program has been partially funded by a
$14.3 million grant from the California Institute for Regenerative
Medicine (CIRM). OPC1 has received Regenerative Medicine Advanced
Therapy (RMAT) designation and Orphan Drug designation from the
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
administered 21 to 42 days post-injury in patients with subacute
motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal
cord injuries (SCI). Patient enrollment in this study is complete;
96% of patients reported one level of improved motor function and
33% of patients reported two levels of improved motor function.
Patients continue to be evaluated on a long-term basis. Patients
enrolled in the study had experienced severe paralysis of the upper
and lower limbs. The primary endpoint in the study was safety.
Secondary outcome measures included neurological function 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.
About Neurgain Technologies, Inc.
Neurgain Technologies (NGT) was founded in 2013 to develop
technologies focused on the treatment of neurodegenerative diseases
and neuropathic pain. Neurgain is developing a novel gene therapy
technology and delivery devices to treat chronic neuropathic pain
and spinal spasticity. 7-8% of the population suffers from
Neuropathic Pain. Current therapeutic management is not working:
Drugs in use have poor efficacy, and cause undesirable side effects
such as resistance, addiction, and other disorders. NGT’s mission
is to positively impact this problem by means of our patented
innovation to provide a therapy that works and improves the
patient’s quality of life. The Company is developing two assets: 1.
Spinal subpial gene delivery platform (device), 2. Pre-clinical
gene therapy for severe neuropathic pain. NGT plans to license the
platform delivery technologies to multiple pharma/biotech which are
developing gene or cell therapies in CNS. Neurgain’s business
strategy involves the out-licensing of spinal cord delivery
technology and clinical development of a gene therapy for
neuropathic pain and chronic spasticity. For more information,
please visit https://neurgaintech.com/.
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 the
potential benefits of using the Neurgain PDI device.
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/20210208005187/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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