Aspen Neuroscience Announces MRI-Guided
Transplantation Approach for ASPIRO Clinical Trial
with the ClearPoint® Navigation System
SAN
DIEGO, June 20, 2024 /PRNewswire/ -- Aspen
Neuroscience, Inc. announced today that it is utilizing the
MRI-guided ClearPoint® Navigation System for all patients enrolled
in the recently launched ASPIRO Phase 1/2a clinical trial for
transplantation of dopaminergic neuron precursor cells (DANPCs) in
patients with Parkinson's Disease (PD). ASPIRO is an open label
trial to assess safety and tolerability of ANPD001, an autologous,
dopaminergic neuron cell replacement therapy for participants with
moderate to severe PD.
"By the time of diagnosis, it is common for people with
Parkinson's to have lost the majority of dopaminergic neurons,
leading to progressive loss of motor and neurological function,"
explained Edward Wirth III, MD, PhD,
Chief Medical Officer of Aspen Neuroscience. "To replace these lost
cells, we must target a very specific area of the brain with a high
degree of surgical precision. Utilizing the latest advances in
intraoperative MRI guided techniques provided by the ClearPoint
system, the patient's new cells are transplanted, one microliter at
a time, to the exact area where they are most needed."
These DANPCs are transplanted to the putamen, a small section
located in the mid-brain, in a single transplantation procedure
under ClearPoint MRI guidance, using the SmartFlow® Cannula and the
Aspen Metered Delivery Syringe (AMDS). This surgical approach was
developed by the trial's lead neurosurgeon and renowned MRI-guided
stereotactic neurosurgery pioneer Paul
Larson, MD, FAANS, professor of neurosurgery at the
University of Arizona College of
Medicine – Tucson and neurosurgeon
at Banner University Medical Center, Tucson.
"We are honored to be a part of such an important and
groundbreaking study to demonstrate the ability of personalized
medical approaches for treating neurodegenerative conditions,"
explained Jeremy Stigall, Chief
Business Officer at ClearPoint Neuro. "The ClearPoint Neuro
Navigation System is being used successfully in more than 80
centers worldwide for multiple applications, and investigational
gene and cell therapy trials. We are thrilled to partner with
Aspen to support the first
multi-center trial for an autologous neuron replacement therapy for
Parkinson's disease."
The ClearPoint System utilizes intraprocedural MR images to
provide real-time navigational instruction for the neurosurgeon,
and confirmation that the desired anatomical target has been
reached with submillimetric accuracy. Combined with The SmartFlow®
Cannula, which is less than 2 millimeters in diameter, this allows
minimally-invasive delivery of therapeutic agents in a patient's
brain.
About the ASPIRO Trial
The Autologous-derived Study of
a Parkinson's Investigational Regenerative therapy in an Open-label
trial (ASPIRO) is a Phase 1/2a clinical trial to assess the safety,
tolerability, and potential efficacy of ANPD001 in patients with
moderate to severe Parkinson's disease. The dose escalation
study 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
ANPD001. Secondary endpoints include improvement in "on" time, when
patients experience periods of symptom control, and improvements in
motor symptoms and quality of life based on standard Parkinson's
disease rating scales.
About ANPD001
ANPD001 is an investigational autologous
neuronal replacement therapy being studied as a regenerative
therapy for PD. Aspen's
personalized approach means that patients do not require
immunosuppressive drugs to counteract the body's immune response
against foreign cells.
Aspen's manufacturing process
starts from a small sample of the patient's own skin cells,
followed by reprogramming to induced pluripotent stem cells (iPSCs)
and then differentiation of the iPSCs into DANPCs. These DANPCs are
transplanted into the putamen, replacing cells that were lost or
damaged due to disease. The quality of each person's cells is
assessed at every manufacturing stage
using Aspen's proprietary machine learning-based genomics
tests.
About ClearPoint Neuro
ClearPoint Neuro, Inc. (NASDAQ:
CLPT) is a device, cell, and gene therapy-enabling company offering
precise navigation to the brain and spine. The Company uniquely
provides both established clinical products as well as pre-clinical
development services for controlled drug and device delivery. The
Company's flagship product, the ClearPoint Neuro Navigation System,
has FDA clearance and is CE-marked. ClearPoint Neuro is engaged
with healthcare and research centers in North America, Europe, Asia,
and South America. The Company is
also partnered with the most innovative pharmaceutical / biotech
companies, academic centers, and contract research organizations,
providing solutions for direct CNS delivery of therapeutics in
pre-clinical studies and clinical trials worldwide. To date,
thousands of procedures have been performed and supported by the
Company's field-based clinical specialist team, which offers
support and services to our customers and partners worldwide. For
more information, please visit www.clearpointneuro.com.
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.
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SOURCE Aspen Neuroscience, Inc.