BioTime Announces Issuance of U.S. Patent for Method of Reducing Cavitation in Patients with Acute Spinal Cord Injury
May 06 2019 - 8:00AM
Business Wire
BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage
biotechnology company developing cellular therapies for unmet
needs, announced today the issuance of a Notice of Allowance for a
patent from the United States Patent and Trademark Office (USPTO)
for United States Patent Application No. 15/156,316 for a method of
reducing spinal cord injury (SCI)-induced parenchymal cavitation in
patients that have suffered an acute spinal cord injury. The
claimed method involves injecting oligodendrocyte progenitor cells
(OPCs) derived from human pluripotent stem cells into the SCI site
and covers both human embryonic and induced pluripotent stem
cell-derived OPCs. The issued patent would have a term that expires
no earlier than 2036.
“We believe OPC1 acts via several distinct mechanisms to aid the
recovery of SCI patients, one of which is the prevention or
reduction of cavitation, and we are pleased at having received an
allowance on this important patent, which we believe further
enhances our OPC1 cell therapy program,” stated Brian M. Culley,
Chief Executive Officer of BioTime. “Cavitation is a destructive
process that occurs within the spinal cord following injuries and
typically leads to permanent loss of motor and sensory function.
Patients with cavitation may develop a condition known as
syringomyelia, which results in additional neurological and
functional damage and can result in chronic pain. A key finding
from our Phase I/IIa SCiStar clinical study of OPC1 for treating
acute SCIs was that 95% of subjects showed evidence that OPC1 cells
engrafted at the injury site and helped to prevent cavitation,
which was confirmed via magnetic resonance imaging (MRI)
scans.”
About OPC1
OPC1 is currently being tested in Phase I/IIa clinical trial
known as SCiStar, for the treatment of acute spinal cord injuries.
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.
The clinical development of 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 for the treatment of acute SCI
and has been granted Orphan Drug designation from the U.S. Food and
Drug Administration (FDA).
About the SCiStar Trial
The SCiStar trial is an open-label, single-arm trial testing
three sequential escalating doses of OPC1 administered at up to 20
million OPC1 cells in 25 subjects with subacute motor complete
(AIS-A or AIS-B) cervical (C-4 to C-7) SCI. These individuals have
essentially lost all movement below their injury site and
experience severe paralysis of the upper and lower limbs. AIS-A
subjects have lost all motor and sensory function below their
injury site, while AIS-B subjects have lost all motor function but
may have retained some minimal sensory function below their injury
site. OPC1 is administered 21 to 42 days post-injury. Subjects will
be followed by neurological exams and imaging procedures to assess
the safety and activity of the product.
Improvements in upper extremity motor function are being
measured using the International Standards for Neurological
Classification of Spinal Cord Injury (ISNCSCI) scale, widely used
to quantify functional status of patients with spinal cord
injuries. Both subjects and physicians consistently report that
improvements in upper extremity motor function are the most
desirable functional improvement target in the quadriplegic
population, since even relatively modest changes can potentially
have a significant impact on functional independence, quality of
life and cost of care. The SCiStar study is monitoring two separate
ISNCSCI measurements of upper extremity motor function. The upper
extremity motor score (UEMS), is a linear scale used to quantify
motor function at each of five upper extremity muscle groups
driving arm and hand function; these scores are also used to
determine "motor levels", which define the level within the cord
above which a subject has normal function. As suggested by existing
research, patients with severe spinal cord injuries that show two
motor levels of improvement on at least one side may regain the
ability to perform daily activities such as feeding, dressing and
bathing, which significantly reduces the overall level of daily
assistance needed for the patient and associated healthcare
costs.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company developing new
cellular therapies for degenerative retinal diseases, neurological
conditions associated with demyelination, and aiding the body in
detecting and combating cancer. BioTime’s programs are based on its
proprietary cell-based therapy platform and associated development
and manufacturing capabilities. With this platform BioTime develops
and manufactures specialized, terminally-differentiated human cells
from its pluripotent and progenitor cell starting materials. These
differentiated cells are developed either to 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. BioTime’s clinical
assets include (i) OpRegen®, a retinal pigment epithelium
transplant therapy in Phase I/IIa development for the treatment of
dry age-related macular degeneration, the leading cause of
blindness in the developed world; (ii) OPC1, an oligodendrocyte
progenitor cell therapy in Phase I/IIa development for the
treatment of acute spinal cord injuries; and (iii) VAC2, an
allogeneic cancer immunotherapy of antigen-presenting dendritic
cells currently in Phase I development for the treatment of
non-small cell lung cancer. For more information, please visit
www.biotimeinc.com.
Forward-Looking Statements
BioTime 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 our belief
about the ability of OPC1 to act via several distinct mechanisms of
action to aid recovery of SCI injury patients, and about the
validation of our OPC1 cell therapy program as a result of the
receiving the Notice of Allowance for a patent. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause BioTime’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,
without limitation, risk and uncertainties related to: BioTime’s
ability to raise additional capital when and as needed, to advance
its product candidates; BioTime’s ability to develop and
commercialize product candidates; the failure or delay in starting,
conducting and completing clinical trials or obtaining FDA or
foreign regulatory approval for BioTime’s product candidates in a
timely manner; the therapeutic potential of BioTime’s product
candidates, and the disease indications for which BioTime intends
to develop its product candidates; BioTime’s ability to conduct and
design successful clinical trials, to enroll a sufficient number of
patients, to meet established clinical endpoints, to avoid
undesirable side effects and other safety concerns, and to
demonstrate sufficient efficacy of its product candidates;
developments by BioTime competitors that make BioTime’s product
candidates less competitive or obsolete; BioTime’s ability to
manufacture its product candidates for clinical development and, if
approved, for commercialization, and the timing and costs of such
manufacture; the performance of third parties in connection with
the development and manufacture of BioTime’s product candidates,
including third parties conducting clinical trials as well as
third-party suppliers and manufacturers; the potential of BioTime’s
cell therapy platform, and BioTime’s plans to apply its platform to
research, develop and commercialize our product candidates;
BioTime’s ability, and the ability of its licensors, to obtain,
maintain, defend and enforce intellectual property rights
protecting BioTime’s product candidates, and BioTime’s ability to
develop and commercialize its product candidates without infringing
the proprietary rights of third parties; BioTime’s ability to
recruit and retain key personnel; and BioTime’s ability to
successfully integrate the operations of Asterias into BioTime.
BioTime’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. For a detailed description of BioTime’s risks and
uncertainties, you are encouraged to review its documents filed
with the SEC including its recent filings on Form 8-K, Form 10-K
and Form 10-Q. You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date on
which they were made. BioTime 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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BioTime Inc. IRIoana C. Hone(ir@biotimeinc.com)(510)
871-4188
Solebury Trout IRGitanjali Jain
Ogawa(Gogawa@troutgroup.com)(646) 378-2949
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