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Alzamend Neuro Seeks FDA Nod For Dementia Immunotherapy Study

Alzamend Neuro Seeks FDA Nod For Dementia Immunotherapy Study

阿爾茲修正神經尋求 FDA 為癡呆症免疫療法研究點頭
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.
  • 修正神經公司 （納斯達克：阿爾 ZN）向 FDA 提交了一份研究性新藥申請，用於其免疫治療候選人 ALZN002。
  • 候選產品旨在治療輕度至中度阿爾茨海默氏症類型的癡呆症。
  • ALZN002 是一種專有的「活性」免疫療法產品，這意味著每個患者的免疫系統都會產生它。
  • 它由自體樹突狀細胞（DC）組成，這些細胞是從每個患者中獲取的激活白細胞，以便它們可以在身體外部進行工程設計，以攻擊阿爾茨海默氏相關的澱粉樣蛋白 β 蛋白。
  • 相關： 在 Biogen-Eisai 令人驚訝的阿爾茨海默氏症試驗獲勝後，這些股票正處於雷達狀態。
  • 這些 DC 是用新穎的澱粉樣蛋白 β 肽脈衝而成，旨在增強患者的免疫系統對抗阿爾茨海默氏症的能力。
  • ALZN002-01 1/2A 期試驗將評估與患有輕度至中度阿爾茨海默氏症癡呆症的 20 至 30 名安慰劑相比，多劑量 ALZN002 的安慰劑的安全性，耐受性和有效性。
  • 價格行動： 在上次檢查星期四，阿爾 ZN 股價下跌了 6.78％，至 1.10 美元。
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