Alzamend Neuro Seeks FDA Nod For Dementia Immunotherapy Study

  • Alzamend Neuro Inc ALZN submitted an investigational new drug application to the FDA for its immunotherapy candidate, ALZN002. 
  • The product candidate is designed to treat mild to moderate dementia of the Alzheimer's type. 
  • ALZN002 is a proprietary "active" immunotherapy product, which means each patient's immune system produces it. 
  • It consists of autologous dendritic cells (DCs) that are activated white blood cells taken from each patient so that they can be engineered outside of the body to attack Alzheimer's-related amyloid-beta proteins. 
  • Related: These Stocks Are On The Radar After Biogen-Eisai's Surprising Alzheimer's Trial Win.
  • These DCs are pulsed with a novel amyloid-beta peptide designed to bolster the ability of the patient's immune system to combat Alzheimer's. 
  • The ALZN002-01 Phase 1/2A trial will assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared to placebo in 20‑30 subjects with mild to moderate dementia of the Alzheimer's type. 
  • Price Action: ALZN shares are down 6.78% at $1.10 on the last check Thursday.
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