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FDA Grants Fast Track Designation to ANPD001 for Parkinson’s Disease Treatment

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Aspen Neuroscience, a clinical development-stage company, recently announced a significant milestone in the fight against Parkinson’s disease (PD).

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ANPD001, an autologous (personalized) investigational cell therapy designed to treat Parkinson’s disease by replacing lost dopamine neurons.

This designation aims to accelerate the development and review of drugs that address serious conditions and unmet medical needs.

Key Highlights:

  1. Purpose of Fast Track Designation: The FDA’s Fast Track Designation is intended to bring crucial new drugs to patients sooner. This designation facilitates the drug’s development and expedites its review. It also offers benefits like early and frequent interactions with the FDA during the clinical development process and eligibility for accelerated approval and priority review.
  2. ANPD001’s Potential: ANPD001 is under investigation as a treatment for PD by replacing the dopamine neurons that are lost due to the disease. Damien McDevitt, PhD, the president and CEO of Aspen Neuroscience, expressed his gratitude for the FDA’s recognition of the potential of ANPD001 as an autologous dopamine replacement therapy. He emphasized the significant unmet medical need for advanced treatment options for Parkinson’s disease patients.
  3. Upcoming Clinical Trial: Aspen Neuroscience is gearing up to launch a Phase 1/2a clinical trial for ANPD001, targeting participants with moderate to severe PD. This decision follows the company’s 2022 Trial-Ready Screening Cohort Study, which aimed to screen, enroll, and begin cell manufacturing for potential patient candidates. This upcoming study will be the first multicenter Phase 1/2a trial of an autologous iPSC-derived therapy in the U.S.
  4. About ANPD001: ANPD001 is an investigational cell therapy product that uses a patient’s own skin cells to create dopamine neuronal precursor cells (DANPCs). These cells are then implanted into the patient to replace cells lost or damaged by Parkinson’s disease. Aspen’s unique approach involves using artificial intelligence-based genomics tests to assess the quality of each patient’s cells at every manufacturing stage.
  5. Parkinson’s Disease Overview: Parkinson’s disease is the second most common neurodegenerative disease globally. It is characterized by both non-motor symptoms, such as mental and behavioral changes, and motor symptoms resulting from the loss of dopamine neurons in the brain. Currently, there is no therapy that can halt, replace, or prevent the loss of dopamine neurons or slow PD’s progression.
  6. About Aspen Neuroscience: Based in San Diego, Aspen Neuroscience focuses on autologous regenerative medicine. The company is at the forefront of developing patient-derived iPSCs to create personalized cell therapies for diseases with high unmet medical needs, starting with Parkinson’s disease.

For more information about Aspen Neuroscience and its groundbreaking work, you can visit their official website.

*** All content on is for informational purposes only. All medical questions and concerns should always be consulted with your licensed healthcare provider.

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