ALAMEDA, Calif.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24BTX&src=ctag" target="_blank"gt;$BTXlt;/agt; lt;a href="https://twitter.com/hashtag/SCI?src=hash" target="_blank"gt;#SCIlt;/agt;–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.
Contacts
BioTime Inc. IR
Ioana C. Hone
(ir@biotimeinc.com)
(510)
871-4188
Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@troutgroup.com)
(646)
378-2949