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Cassava Sciences Advances Alzheimer's Drug Through High-Stakes Phase 3 Trials

Cassava Sciences Advances Alzheimer's Drug Through High-Stakes Phase 3 Trials

cassava sciences通過高風險的3期試驗推進了治療阿爾茨海默病的藥物
Benzinga ·  14:03

On Monday, Rick Barry, the executive chairman of Cassava Sciences Inc (NASDAQ:SAVA), wrote a letter to shareholders and employees.

週一,Cassava Sciences公司(NASDAQ:SAVA)的執行主席Rick Barry致股東和員工的一封信。

He said the company is in the final stages of testing its Alzheimer's drug candidate, simufilam, with significant financial and emotional stakes.

他表示公司正在對阿爾茨海默病候選藥物simufilam進行最後階段的測試,這涉及到重大的財務和情感投入。

The company is conducting Phase 3 trials to demonstrate the drug's efficacy and safety.

該公司正在進行第3期試驗,以證明這種藥物的功效和安全性。

Related: Alzheimer's-Focused Cassava Sciences Faces Controversy as Key Collaborator Accused of Scientific Misconduct.

相關閱讀:以阿爾茨海默病爲焦點的 Cassava Sciences面臨着合作者被指控科學不端的爭議。

These trials, costing hundreds of millions of dollars, are essential for determining if simufilam can significantly impact the lives of Alzheimer's patients and their families.

這些耗資數億美元的試驗對於確定simufilam能否顯著改變阿爾茨海默病患者及其家屬的生活至關重要。

Cassava Sciences' executive chairman highlights that the first Phase 3 trial, involving 804 patients, is expected to report by December 2024.

Cassava Sciences的執行主席強調,第一期3期試驗涉及804名患者,預計將於2024年12月發佈報告。

The second Phase 3 trial will include 1,125 patients and is anticipated to conclude by June 2025. Both trials are designed to rigorously assess simufilam's effectiveness compared to a placebo. The outcome of these trials will be critical in determining the drug's future and its potential to alter Alzheimer's treatment.

第二期3期試驗將包括1,125名患者,並預計將於2025年6月結束。這兩個試驗都旨在嚴格評估simufilam與安慰劑的效果對比。這些試驗的結果將對決定該藥物未來及其改變阿爾茨海默病治療的潛力至關重要。

Recently, the Board of Directors appointed Richard (Rick) Barry as Executive Chairman and the company's principal executive officer, effective immediately. The company is searching for a new permanent CEO.

最近,董事會任命Richard (Rick) Barry爲執行主席和該公司的首席執行官,立即生效。該公司正在尋找新的永久性首席執行官。

In July, Cassava Sciences engaged the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange Commission (SEC) amid ongoing investigations into the company and two senior employees.

在7月份,Cassava Sciences公司在針對該公司和兩名高層員工的持續調查中請教了美國司法部和美國證券交易委員會。

Cassava's board formed an Ad Hoc Investigation Committee to oversee outside counsel conducting the investigation. The Committee also oversees the company's disclosures related to the investigation, the company said in an SEC filing.

Cassava的董事會成立了一個特別調查委員會來監督負責調查的外部律師。該委員會還監督公司與調查相關的披露,公司在SEC備案中表示。

The credibility of the clinical trial results for an experimental Alzheimer's drug has been called into question following a critical inspection report by the FDA.

FDA的一份關鍵檢查報告稱,一種實驗性阿爾茨海默病藥物的臨床試驗結果的可信度受到質疑。

The FDA report, which was released under the Freedom of Information Act, highlighted several issues with the clinical trial work conducted by pharmacologist Hoau-Yan Wang at the City University of New York (CUNY), reported Science.org.

由科學網站Science.org報道,根據《信息自由法》發佈的FDA報告強調了藥理學家王浩彥在紐約市立大學(CUNY)進行的臨床試驗工作存在幾個問題。

Price Action: SAVA stock is trading 22.7% higher at $12.37 at last check Monday.

股價動態:在週一的最後一次檢查中,SAVA股票以12.37美元的漲幅上漲22.7%。

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