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Alzamend Neuro Seeks FDA Nod For Dementia Immunotherapy Study

Alzamend Neuro Seeks FDA Nod For Dementia Immunotherapy Study

Alzamend Neuro 为痴呆免疫疗法研究寻求美国食品药品管理局点头
Benzinga Real-time News ·  2022/09/29 12:31
  • Alzamend Neuro Inc (NASDAQ: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.
  • Alzamend Neuro Inc 纳斯达克股票代码：ALZN）向美国食品药品管理局提交了其免疫疗法候选药物 ALZN002 的研究性新药申请。
  • 候选产品旨在治疗阿尔茨海默型的轻度至中度痴呆。
  • ALZN002 是一种专有的 “活性” 免疫疗法产品，这意味着每个患者的免疫系统都会产生这种产品。
  • 它由自体树突状细胞（DC）组成，这些自体树突状细胞（DC）是从每位患者身上提取的活化白细胞，因此可以在体外对其进行改造，以攻击与阿尔茨海默氏症相关的β淀粉样蛋白。
  • 相关： 在Biogen-Eisai出人意料的阿尔茨海默氏症试验获胜后，这些股票备受关注。
  • 这些DC由一种新的β淀粉样肽脉冲而成，旨在增强患者免疫系统对抗阿尔茨海默氏症的能力。
  • ALZN002-01 1/2A 期试验将评估在 20-30 名阿尔茨海默型轻度至中度痴呆受试者中，与安慰剂相比，多剂量递增剂量 ALZN002 的安全性、耐受性和有效性。
  • 价格走势： 周四的最后一张支票中，ALZN股价下跌6.78％，至1.10美元。
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