Aspen Neuroscience's ANPD001 Gets FDA Fast Track for Parkinson's Trial
Aspen Neuroscience, Inc. has received a Fast Track designation from the U.S. Food & Drug Administration (FDA) for its ANPD001 therapy, a personalized treatment for Parkinson's disease. This marks a significant step forward in the company's ASPIRO Phase 1/2a clinical trial.
The ASPIRO trial is currently in its Cohort 3, which uses Aspen's new commercial formulation of ANPD001. This formulation allows for immediate dosing upon arrival at the institution, significantly streamlining surgical workflow. The trial is evaluating the safety, tolerability, and preliminary efficacy of ANPD001 in levodopa-responsive patients aged 50-70 with moderate to advanced Parkinson's disease.
ANPD001 is the most advanced autologous investigational cell therapy in the U.S. for treating Parkinson's disease. Aspen's approach uses a patient's own cells, avoiding immune rejection and offering a tailored treatment. The primary endpoints of the ASPIRO trial will be reported at 12 months, with long-term follow-up extending to 15 years.
Aspen Neuroscience, Inc. has initiated Cohort 3 in its ASPIRO Phase 1/2a clinical trial, utilizing a new commercial formulation of ANPD001. This formulation's immediate dosing capability and the trial's promising early results indicate a potential breakthrough in Parkinson's disease treatment.
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