Asterias Biotherapeutics, Inc. (NYSE MKT:AST) today announced that
Lucas Lindner of Eden, Wisconsin, a quadriplegic patient who has
regained functional use of his fingers, hands and lower arms after
receiving the company’s investigational stem cell therapy for
complete cervical spinal cord injury, AST-OPC1, will throw out the
ceremonial first pitch of a Major League Baseball game in Milwaukee
on Sunday, August 13th.
“Lucas has been an inspiration to our employees at Asterias who
have worked so hard to bring AST-OPC1 to where it is now being
administered to patients in a clinical trial, as well as to
thousands of others who have seen his story on the internet or on
television,” said Mike Mulroy, President and CEO of Asterias.
“We are excited about the progress he has made since
receiving 10 million cells of AST-OPC1 and look forward to cheering
him on as he takes the field before the game.”
Lucas suffered a severe spinal cord injury when his car swerved
off the road into a tree to avoid hitting a deer in May 2016. He
was flown to the hospital and received immediate surgery to
stabilize his spine. He was left without the ability to move his
limbs below the neck and upper arms.
In June 2016, Lucas received 10 million cells of AST-OPC1 in
Asterias’ ongoing SCiStar Phase 1/2a clinical study by Shekar N.
Kurpad, MD, PhD, Sanford J. Larson Professor and Chairman,
Department of Neurosurgery at the Medical College of Wisconsin and
Director of the Froedtert & Medical College of Wisconsin Spinal
Cord Injury Program. Lucas has since regained the ability to move
triceps, hands and fingers.
As of his latest follow-up visit (12 months following
administration of AST-OPC1), Lucas has achieved two motor levels of
improvement on one side of his body. 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.
"Throwing out the first pitch at a Major League game is not
something I could have imagined a year ago,” said Lucas. “I want to
show everyone that there is hope that spinal cord injury patients
can regain function. I am looking forward to going back to school,
pursuing my dream of working in the IT field and living
independently someday."
“When I first met Lucas about a year ago, he had some use of his
arms and little to no use of his hands or fingers,” said Dr.
Kurpad. “The fact that he is throwing out the first pitch at a
Major League Baseball game is amazing. It illustrates the strides
medical science is starting to make in helping paralyzed patients
regain useful function. I'm very encouraged by the early
results we are seeing with AST-OPC1 and am grateful for the
improvement Lucas has made.”
Asterias has now completed enrollment and dosing in four of the
five planned SCiStar study cohorts and enrolled twenty-two patients
in the SCiStar study. Twenty-seven patients have been administered
AST-OPC1 after including patients from a previous Phase 1 safety
trial and results-to-date continue to support the safety of
AST-OPC1. In June 2017, Asterias reported 9 month data from the
AIS-A 10 million cell cohort that showed improvements in arm, hand
and finger function observed at 3-months and 6-months following
administration of AST-OPC1 were confirmed and in some patients
further increased at 9-months. The company intends to complete
enrollment of the entire SCiStar study later this year, with
multiple safety and efficacy readouts anticipated during the
remainder of 2017 and 2018.
To view a video on Lucas’ story, click on the following link:
https://youtu.be/1DerDpM_FO4.
Broadcast quality b-roll footage is available for news media use
by request by contacting mark@reachthenextlevel.com.
About the SCiStar Trial
The SCiStar trial is an open-label, single-arm
trial testing three sequential escalating doses of AST-OPC1
administered at up to 20 million AST-OPC1 cells in as many as 35
patients with subacute, C-4 to C-7, motor complete (AIS-A or AIS-B)
cervical SCI. These individuals have essentially lost all movement
below their injury site and experience severe paralysis of the
upper and lower limbs. AIS-A patients have lost all motor and
sensory function below their injury site, while AIS-B patients have
lost all motor function but may have retained some minimal sensory
function below their injury site. AST-OPC1 is being administered 21
to 42 days post-injury. Patients will be followed by neurological
exams and imaging procedures to assess the safety and activity of
the product.
The study is being conducted at eight centers in
the U.S. and the company plans to increase this to up to 12 sites
to accommodate the expanded patient enrollment. Clinical sites
involved in the study include the Medical College of Wisconsin in
Milwaukee, Shepherd Medical Center in Atlanta, University of
Southern California (USC) jointly with Rancho Los Amigos National
Rehabilitation Center in Los Angeles, Indiana University, Rush
University Medical Center in Chicago, Santa Clara Valley Medical
Center in San Jose jointly with Stanford University, Thomas
Jefferson University Hospital, in partnership with Magee
Rehabilitation Hospital, in Philadelphia, and UC San Diego Health
in San Diego.
Asterias has received a Strategic Partnerships
Award grant from the California Institute for Regenerative
Medicine, which provides $14.3 million of non-dilutive funding for
the Phase 1/2a clinical trial and other product development
activities for AST-OPC1.
Additional information on the Phase 1/2a trial,
including trial sites, can be found at www.clinicaltrials.gov,
using Identifier NCT02302157, and at the SCiStar Study Website
(www.SCiStar-study.com).
About AST-OPC1
AST-OPC1, an oligodendrocyte progenitor
population derived from human embryonic stem cells originally
isolated in 1998, has been shown in animals and in vitro to have
three potentially reparative functions that address the complex
pathologies observed at the injury site of a spinal cord injury.
These activities of AST-OPC1 include production of neurotrophic
factors, stimulation of vascularization, and induction of
remyelination of denuded axons, all of which are critical for
survival, regrowth and conduction of nerve impulses through axons
at the injury site. In preclinical animal testing, AST-OPC1
administration led to remyelination of axons, improved hindlimb and
forelimb locomotor function, dramatic reductions in injury-related
cavitation and significant preservation of myelinated axons
traversing the injury site.
In a previous Phase 1 clinical trial, five
patients with neurologically complete, thoracic spinal cord injury
were administered two million AST-OPC1 cells at the spinal cord
injury site 7-14 days post-injury. Based on the results of this
study, Asterias received clearance from FDA to progress testing of
AST-OPC1 to patients with cervical spine injuries in the current
SCiStar study, which represents the first targeted population for
registration trials. Asterias has completed enrollment in the
first four cohorts of this study. Results to date have continued to
support the safety of AST-OPC1. Additionally, Asterias has
recently reported results suggesting reduced cavitation and
improved motor function in patients administered AST-OPC1 in the
SCiStar trial.
About Asterias
Biotherapeutics
Asterias Biotherapeutics, Inc. is a
biotechnology company pioneering the field of regenerative
medicine. The company's proprietary cell therapy programs are based
on its pluripotent stem cell and immunotherapy platform
technologies. Asterias is presently focused on advancing three
clinical-stage programs which have the potential to address areas
of very high unmet medical need in the fields of neurology and
oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently
in a Phase 1/2a dose escalation clinical trial in spinal cord
injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is
undergoing continuing development by Asterias based on promising
efficacy and safety data from a Phase 2 study in Acute Myeloid
Leukemia (AML), with current efforts focused on streamlining and
modernizing the manufacturing process. AST-VAC2 (antigen-presenting
allogeneic dendritic cells) represents a second generation,
allogeneic cancer immunotherapy. The company's research partner,
Cancer Research UK, plans to begin a Phase 1/2a clinical trial of
AST-VAC2 in non-small cell lung cancer in 2017. Additional
information about Asterias can be found at
www.asteriasbiotherapeutics.com.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or
operating and/or clinical research 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.
Contacts:
Investor Relations
(510) 456-3892
InvestorRelations@asteriasbio.com
or
EVC Group, Inc.
Michael Polyviou/Greg Gin
(646) 445-4800
mpolyviou@evcgroup.com
Media
Thomas D. Gibson
GIBSON Communications, LLC
(201) 476-0322 – Main
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Corporate B-Roll available upon request by contacting Mark Leonard at: mark@reachthenextlevel.com
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