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XBiotech Announces Enrollment Completion of Phase I Clinical Trial for Hutrukin, a Novel Candidate Therapy for Stroke

XBiotech Announces Enrollment Completion of Phase I Clinical Trial for Hutrukin, a Novel Candidate Therapy for Stroke

xBiotech宣佈Hutrukin的I期臨床試驗註冊完成,Hutrukin是一種新型的中風候選療法
XBiotech ·  2023/09/26 12:00

AUSTIN, Texas, Sept. 26, 2023 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) Announces that Hutrukin is being developed by XBiotech as a breakthrough therapy to reduce brain injury after stroke. The last subject in a randomized, open-label, placebo-controlled Phase I dose escalation clinical study has been enrolled. XBiotech discovered, manufactures, and is conducting this clinical study of Hutrukin.

得克薩斯州奧斯汀,9月2023年26日(環球通訊社)--XBiotech Inc.(納斯達克代碼:XBIT)宣佈,XBiotech正在開發Hutrukin,作為減少中風後腦損傷的突破性療法。一項隨機、開放標籤、安慰劑對照的I期劑量遞增臨床研究的最後一個受試者已經入選。XBiotech發現、製造並正在進行這項Hutrukin的臨床研究。

The primary objective of the Phase I study is to evaluate safety and pharmacokinetics of Hutrukin in healthy volunteers. Sequential dose escalation was conducted using three cohorts of subjects, each receiving a single intravenous infusion of either placebo or Hutrukin, with eight subjects in each cohort.

第一階段研究的主要目標是評估Hutrukin在健康志願者中的安全性和藥代動力學。使用三組受試者進行連續劑量遞增,每組受試者接受一次安慰劑或Hutrukin靜脈輸注,每組八名受試者。

Hutrukin is a candidate drug being developed to reduce brain injury following ischemic stroke. Globally, one in four people over age 25 will experience a stroke—the leading cause of disability and second leading cause of death in the world. An ischemic stroke occurs when a blood clot obstructs a blood vessel that supplies the blood to the brain. Blockage of blood flow to the brain results in brain injury, loss of brain function, or death.

Hutrukin是一種正在開發的候選藥物,用於減少缺血性中風後的腦損傷。在全球範圍內,25歲以上的人中有四分之一將經歷中風--中風是世界上導致殘疾的主要原因和第二大死亡原因。當血液凝塊阻塞向大腦供應血液的血管時,就會發生缺血性中風。腦血流受阻會導致腦損傷、腦功能喪失或死亡。

Emergency treatment for stroke includes "clot-busting" drugs or mechanical catheters to re-open arteries, both of which are associated with a phenomenon known as reperfusion injury. Reperfusion injury is the damage that occurs to previously healthy brain tissue after a clot is removed from the artery and blood supply is returned to the healthy but hypoxic brain tissue. This secondary damage is believed to be the result of an inflammatory response resulting from the return of blood cells to the region of the brain that had been previously deprived of blood and oxygen (which is the hypoxic brain tissue).

中風的緊急治療包括“溶解血栓”藥物或機械導管以重新開放動脈,這兩者都與一種被稱為再灌流損傷。再灌注損傷是指在血栓從動脈中移除,血液供應恢復到健康但缺氧的腦組織後,對以前健康的腦組織造成的損害。這種二次損傷被認為是由於血細胞返回到之前失去血液和氧氣的大腦區域(即缺氧性腦組織)而引起的炎症反應的結果。

When administered immediately prior to artery-opening procedures, Hutrukin may reduce the inflammatory injuries associated with reperfusion. No drug or treatment is currently available to reduce or prevent reperfusion injury. Hutrukin potentially represents a unique and major advance for stroke victims.

如果在動脈開放手術前立即給藥,Hutrukin可能會減少與再灌注相關的炎症損傷。目前還沒有藥物或治療方法可以減少或防止再灌注損傷。Hutrukin可能代表著中風患者的獨特和重大進步。

About True Human Therapeutic Antibodies

關於真正的人類治療性抗體

XBiotech's True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. By harnessing the body's natural immunity to cure disease, True Human antibodies have the potential to revolutionize medicine.

XBiotech的True Human抗體未經修改就來自對某些疾病具有天然免疫力的個人。通過利用人體的自然免疫力來治療疾病,真正的人類抗體有可能給醫學帶來革命性的變化。

About XBiotech
XBiotech is dedicated to pioneering the development of breakthrough therapies derived from natural human immunity. XBiotech discovered genetic engineering tools that enabled identification of rare antibodies present in human donor blood, and has built a pipeline of antibody therapies, including a candidate therapy that could revolutionize arthritis treatment. Headquartered in Austin, Texas, XBiotech has also lead innovation in biomanufacturing technology. For more information, visit www.xbiotech.com.

關於XBiotech
XBiotech致力於開拓源於自然人類免疫的突破性療法的開發。XBiotech發現了基因工程工具,能夠識別存在於人類捐贈者血液中的罕見抗體,並建立了一系列抗體療法,包括一種可能徹底改變關節炎治療的候選療法。總部設在得克薩斯州奧斯汀的XBiotech還引領著生物製造技術的創新。如需更多資訊,請訪問Www.xbiotech.com

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

關於前瞻性陳述的警示說明
本新聞稿包含前瞻性陳述,包括有關涉及重大風險和不確定性的管理層信念和期望的聲明。在某些情況下,您可以通過諸如“可能”、“將”、“應該”、“將”、“可能”、“預期”、“計劃”、“考慮”、“預期”、“相信”、“估計”、“預測”、“專案”、“打算”或“繼續”或這些術語或其他類似術語的否定來識別前瞻性表述,儘管並不是所有的前瞻性表述都包含這些識別詞語。前瞻性陳述在預測未來結果和條件時會受到固有風險和不確定性的影響,這些風險和不確定性可能會導致實際結果與這些前瞻性陳述中預測的結果大相徑庭。這些風險和不確定性受我們提交給美國證券交易委員會的某些檔案中“風險因素”部分所述的披露的影響。前瞻性陳述不是對未來業績的保證,我們的實際運營結果、財務狀況和流動性,以及我們經營的行業的發展,可能與本新聞稿中包含的前瞻性陳述大不相同。我們在本新聞稿中所作的任何前瞻性陳述僅限於本新聞稿發佈之日。我們沒有義務在本新聞稿發佈之日之後根據新資訊、未來事件或其他情況更新我們的前瞻性陳述。

Contact

聯繫方式

Wenyi Wei
wwei@xbiotech.com
Tel. 512-386-2900

魏文儀
郵箱:wwei@xBiotech.com
電話。512-386-2900

譯文內容由第三人軟體翻譯。


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