Award Will Support the First U.S.
Multi-center, Multi-patient Phase 1/2a Trial of an
Autologous Neurological Therapy
SAN
DIEGO, May 15, 2024 /PRNewswire/ -- Aspen
Neuroscience, Inc., a California-based private biotechnology company
developing personalized regenerative therapies, has received a
CLIN2 grant award of $8 million from
the California Institute for Regenerative Medicine (CIRM), the
world's largest institution dedicated to regenerative medicine, to
support clinical research aimed at treating Parkinson's disease
(PD).
Award will support the first U.S.
multi-center, multi-patient Phase 1/2a trial of an autologous
neurological therapy
The grant, a first for an autologous therapeutic for
degenerative neurological conditions, will help advance the
development of ANPD001, an investigational iPSC-derived
dopaminergic neuron replacement therapy.
ANPD001 is being studied in a First in Human Phase 1/2a clinical
trial for patients with moderate to advanced PD, to assess safety
and tolerability. This is the first use of the autologous
approach in a multi-patient and multi-center clinical trial.
"This clinical award represents a significant step forward in
the treatment landscape of Parkinson's disease by advancing
individualized therapy, which has the potential to restore motor
function in patients impacted by this devastating condition," said
Dr. Abla Creasey, PhD, Vice
President of Therapeutics Development at CIRM.
"We are honored to receive support from CIRM, an incredible
sponsor of innovation. ANPD001 was developed in California, and is now being produced and
studied here," said Damien McDevitt,
PhD, President and CEO of Aspen Neuroscience, Inc. "Providing
patients in this study with dopamine neurons made from their own
cells is a huge leap forward for personalized medicine, and has the
potential to impact the entire field of neurodegenerative
disorders."
Affecting more than one million Americans, PD is a
neurodegenerative disorder that causes walking and motor problems,
as well as impaired balance and coordination. Existing therapies
alleviate symptoms but do not treat the underlying disease process,
leading to a significant unmet medical need for those suffering
from this chronic condition.
"Parkinson's disease is the most common neurodegenerative
movement disorder, primarily by depleting dopamine neurons in the
midbrain. By the time of diagnosis, it is common for people
with Parkinson's to have lost the majority of dopaminergic (DA)
neurons, leading to progressive loss of motor and neurological
function," explained Edward Wirth
III, MD, PhD, Chief Medical Officer of Aspen Neuroscience.
"Our Phase 1/2a study has completed enrollment, the first patient
has been dosed and we will continue dosing patients this year."
About the California Institute for Regenerative Medicine
(CIRM)
At CIRM, we never forget that we were created by the
people of California to accelerate
stem cell treatments to patients with unmet medical needs, and act
with a sense of urgency to succeed in that mission.
To meet this challenge, our team of highly trained and
experienced professionals actively partners with both academia and
industry in a hands-on, entrepreneurial environment to fast track
the development of today's most promising stem cell
technologies.
With $5.5 billion in funding and
more than 150 active stem cell programs in our portfolio, CIRM is
one of the world's largest institutions dedicated to helping people
by bringing the future of cellular medicine closer to
reality. For more information go to www.cirm.ca.gov
About the ASPIRO Trial
ASPIRO is an open-label Phase
1/2a clinical trial to assess the safety and tolerability of
ANPD001 in patients with moderate to severe Parkinson's
disease. The trial includes patients 50–70 years of age, and
excludes patients with cognitive impairment and other comorbidities
that could preclude treatment. All enrolled patients are under the
care of a movement disorder specialist.
The primary study endpoint is safety and tolerability of two
sequential escalating doses of ANPD001. Secondary endpoints
include improvement in "on" time, when patients experience periods
of good symptom control, and improvements in motor symptoms and
quality of life based on standard Parkinson's disease rating
scales.
About Aspen Neuroscience
Headquartered in San Diego, Aspen Neuroscience, Inc. is a
clinical development-stage, private company focused on autologous
regenerative medicine. The company's patient-derived iPSC platform
is used to create personalized therapies to address diseases with
high unmet medical needs, beginning with autologous neuron
replacement for Parkinson's disease.
Aspen combines cell biology with the latest machine learning and
genomic approaches to investigate patient-specific, restorative
cell treatments. The company has developed a best-in-class platform
to create and optimize pluripotent-derived cell therapies, which
includes in-house bioinformatics, manufacturing and quality
control. For more information and important updates, please
visit https://www.aspenneuroscience.com.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/aspen-neuroscience-receives-clin2-grant-for-anpd001-from-california-institute-for-regenerative-medicine-cirm-302145692.html
SOURCE Aspen Neuroscience, Inc.