MENLO PARK, Calif.,
Oct. 20, 2014 /PRNewswire/ --
Asterias Biotherapeutics, Inc. (NYSE MKT: AST) announced today that
the Company has signed a Notice of Grant Award (NGA) with the
California Institute of Regenerative Medicine (CIRM), effective
October 1, 2014. The NGA
provides for the immediate release of Clinical Development payments
and the release of additional grant funds pursuant to the
previously announced $14.3 million
CIRM grant award for clinical development of Asterias' product,
AST-OPC1. The grant provides non-dilutive funding to initiate a
Phase 1/2a clinical trial of AST-OPC1 in patients with complete
cervical spinal cord injury and other product development
activities for AST-OPC1.
"We are delighted to formally launch our collaboration with CIRM
for the development of AST-OPC1 neural cells as a potential
pluripotent stem-cell based therapy for spinal cord injury," stated
Pedro Lichtinger, President and CEO
of Asterias. "The signing of the Notice of Grant Award was the last
in a series of milestones required to begin the release of funds
under the CIRM grant."
In August 2014, Asterias received
clearance from the U.S. Food and Drug Administration (FDA) to
initiate the Phase 1/2a clinical trial of AST-OPC1. The approved
trial follows the successful completion of the Phase 1 clinical
study of the product, which met its primary endpoints of safety and
feasibility when administered to five patients with
neurologically-complete, thoracic spinal cord injury.
"There are currently no approved therapies for the more than
12,000 individuals who suffer a spinal cord injury each year in
the United States alone, or for
the approximately 1.3 million Americans who are estimated to be
living with a spinal cord injury," Mr. Lichtinger continued.
"Individuals with spinal cord injury have impaired limb function,
and often suffer from a wide range of additional disabilities that
can each significantly impact quality of life. AST-OPC1 has been
shown to have three potentially reparative functions that address
the complex pathologies observed at the spinal cord injury
site: production of neurotrophic factors, stimulation of
vascularization, and induction of remyelination of denuded axons.
With the Phase 1/2a clinical trial, we look forward to generating
additional data that could further support the potential for
AST-OPC1 to serve as a new therapy for patients with spinal cord
injury."
The new Phase 1/2a clinical trial is designed to assess safety
and activity of escalating doses of AST-OPC1 for complete cervical
spinal cord injuries, the first targeted indication for AST-OPC1.
The trial will be an open-label, single-arm study testing three
escalating doses of AST-OPC1 in 13 patients with subacute, C5-C7,
neurologically-complete cervical spinal cord injury. These
individuals have essentially lost all sensation and movement below
their injury site with severe paralysis of the upper and lower
limbs. AST-OPC1 will be administered 14 to 30 days post-injury.
Patients will be followed by neurological exams to assess the
safety and activity of the product. Selection of the clinical
trial sites is well underway, and the Company expects to begin
patient enrollment during the first quarter of 2015.
About Asterias Biotherapeutics
Asterias' core technologies center on stem cells capable of
becoming all of the cell types in the human body, a property called
pluripotency. Asterias plans to develop therapies based on
pluripotent stem cells to treat diseases or injuries in a variety
of medical fields having major unmet needs and without adequate
therapies available. Asterias initial focus is on two clinical
stage programs including oligodendrocyte progenitor cells
(AST-OPC1) for spinal cord injuries and antigen-presenting
allogeneic dendritic cells (AST-VAC2) for lung cancer.
In October 2013, Asterias acquired
the cell therapy assets of Geron Corporation. These assets included
INDs for the clinical stage AST-OPC1 and AST-VAC1 programs, banks
of cGMP-manufactured AST-OPC1 drug product, cGMP master and working
cell banks of human embryonic stem cells, over 400 patents and
patent applications filed worldwide including broad issued claims
to fundamental platform technologies for the scalable growth of
pluripotent stem cells and compositions of matter for several
hESC-derived therapeutic cell types, research cell banks,
customized reagents and equipment, and various assets relating to
the AST-VAC2 program and preclinical programs in cardiology, and
orthopedics.
Asterias is a majority-owned subsidiary of BioTime, Inc., (NYSE
MKT: BTX), a biotechnology company engaged in research and product
development in the field of regenerative medicine. Additional
information about Asterias can be found at
www.asteriasbiotherapeutics.com.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating
results, future growth in research, technology, clinical
development, and potential opportunities for Asterias, along with
other statements about the future expectations, beliefs, goals,
plans, or prospects expressed by management constitute
forward-looking statements. Any statements that are not historical
fact (including, but not limited to statements that contain words
such as "will," "believes," "plans," "anticipates," "expects,"
"estimates") should also be considered to be forward-looking
statements. Forward-looking statements involve risks and
uncertainties, including, without limitation, risks inherent in the
development and/or commercialization of potential products,
uncertainty in the results of clinical trials or regulatory
approvals, need and ability to obtain future capital, and
maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the businesses of Asterias,
particularly those mentioned in the cautionary statements found in
Asterias' filings with the Securities and Exchange Commission.
Asterias disclaims any intent or obligation to update these
forward-looking statements.
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SOURCE Asterias Biotherapeutics, Inc.