Aspen Neuroscience has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ANPD001, an autologous cell therapy designed to treat Parkinson’s Disease (PD) by replacing lost dopamine neurons.
The clearance enables Aspen to initiate a first-in-patient Phase 1/2a clinical trial for individuals with moderate to severe PD. This follows a 2022 Trial-Ready Screening Cohort Study to screen and enroll potential patient candidates.
ANPD001 uses induced pluripotent stem cells (iPSCs) derived from the patient’s own skin cells to create dopamine neuronal precursor cells (DANPCs), which are then evaluated using quality control assays, including Aspen’s proprietary AI-based genomics tests, before implantation. The Phase 1/2a clinical trial will be the first multicenter trial of an autologous iPSC-derived therapy in the U.S.
The company’s leadership expressed excitement about this major milestone, emphasizing its potential to pave the way for a new treatment for over one million Americans and 10 million people worldwide affected by PD.
The autologous cell therapy approach was developed by Aspen’s co-founders, and the company is focused on personalized regenerative medicine, starting with Parkinson’s disease and extending across the brain and affected organs.
- Personalized Approach: Aspen’s therapy is unique in that it uses the patient’s own cells, reducing the risk of rejection and potentially offering a more targeted treatment for PD.
- Potential Impact: With no current disease-modifying therapy that can stop or slow the progression of PD, Aspen’s ANPD001 could represent a significant advancement in the treatment of this debilitating disease.
- Innovation in Regenerative Medicine: The combination of stem cell biology, artificial intelligence, and genomic approaches in Aspen’s platform showcases the cutting-edge nature of their research and the potential for personalized, restorative treatments in neurodegenerative diseases.
SOURCE Aspen Neuroscience, Inc.