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Aspen Neuroscience Begins Phase 1/2a Clinical Trial for Parkinson's Disease Treatment with Autologous Neuronal Cell Replacement Therapy, Administering First Patient Dose

Thursday, April 18, 2024

Aspen Neuroscience, Inc. recently announced a significant milestone in Parkinson's disease (PD) treatment with the commencement of the ASPIRO trial and the dosing of its first patient. This Phase 1/2a open-label clinical trial aims to evaluate the safety and tolerability of ANPD001, a personalized autologous dopaminergic neuron cell replacement therapy designed for individuals with moderate to severe PD. Aspen Neuroscience, a private biotechnology company, specializes in developing regenerative therapies.

The initial transplantation procedure for the ASPIRO study was performed by Dr. Paul Larson, a distinguished neurosurgeon at Banner – University Medical Center Tucson and a professor of neurosurgery at the University of Arizona College of Medicine – Tucson. Dr. Larson, known for his expertise in interventional MRI-guided stereotaxy, has led numerous innovative efforts in intracranial delivery of novel therapeutics for neurodegenerative disorders.

Dr. Larson emphasized the urgent need for effective treatments in PD, citing the depletion of dopamine neurons in the midbrain as a primary pathology. He highlighted the groundbreaking nature of utilizing an autologous approach in a formal clinical trial, expressing his honor in contributing to this vital research.

Dr. Damien McDevitt, President and CEO of Aspen Neuroscience, hailed the initiation of the ASPIRO trial as a significant milestone in their mission to develop personalized neurologic therapies for conditions like PD. He underscored the current lack of disease-modifying therapies, emphasizing the urgency of their endeavor.

Dr. Edward Wirth III, Chief Medical Officer of Aspen Neuroscience, expressed optimism about the potential of ANPD001 to improve the lives of PD patients. He noted the completion of enrollment for their Trial Ready Cohort Screening Study in 2022 and outlined plans to begin dosing patients in the ASPIRO Phase 1/2a study within the year.

The ASPIRO trial, designed as an open-label Phase 1/2a clinical investigation, focuses on assessing ANPD001's safety and tolerability in individuals aged 50–70 with moderate to severe PD. Notably, patients under study are managed by movement disorder specialists to ensure comprehensive care.

ANPD001 represents a novel approach to PD treatment, offering an investigational autologous neuronal replacement therapy. Aspen's innovative methodology involves deriving dopaminergic neuron precursors (DANPCs) from the patient's own skin cells, eliminating the need for immunosuppressive drugs. This personalized manufacturing process, combined with proprietary machine learning-based genomics tests, ensures the quality and compatibility of the transplanted cells.

The ASPIRO trial's primary endpoint is evaluating the safety and tolerability of two escalating doses of ANPD001, while secondary endpoints include assessing improvements in "on" time, motor symptoms, and overall quality of life using established Parkinson's disease rating scales. This pioneering initiative holds promise for advancing PD treatment paradigms and addressing critical unmet medical needs in the field.



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