Too Lazy progress: Aspen Neuroscience Announces FDA Clearance of Investigational New Drug Application for ANPD001

[Farooqji]

Aspen plans to initiate a first-in-patient Phase 1/2a clinical trial for people with moderate to severe Parkinson’s Disease (PD). This follows the company’s 2022 Trial-Ready Screening Cohort Study to screen, enroll and begin manufacturing cells for potential patient candidates for the clinical trial. This study will be the first multicenter Phase 1/2a trial of an autologous iPSC-derived therapy in the U.S.

aspenneuroscience.com/aspen...

[Bolt_Upright]

About ANPD001

ANPD001 is an investigational cell therapy product being studied as an autologous neuron replacement for Parkinson’s disease. Aspen’s personalized 3-step manufacturing approach starts from a small sample of the patient’s own skin cells, followed by reprogramming to iPSCs and then differentiation into DANPCs. The DANPCs are then provided to the patient via surgery to replace their 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 artificial intelligence-based genomics tests.

About the Phase 1/2a Clinical Trial

The ANPD001 clinical trial is a Phase 1/2a, single-arm, open-label study. The planned dose escalation clinical trial will evaluate the safety, tolerability and preliminary efficacy of ANPD001 in patients with moderate to severe PD.

[Boscoejean]

aspenneuroscience.com/techn...

[Bluebell2022]

I wonder if there is any way to participate in their trial? I scoured their website and. Filled their contact form but no response from them. They say on their website that candidate selection is not done by aspen but no other information about it