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XBiotech Announces First Subject Enrollment in Phase I Clinical Trial for Hutrukin, a Novel Candidate Therapy for Stroke

XBiotech Announces First Subject Enrollment in Phase I Clinical Trial for Hutrukin, a Novel Candidate Therapy for Stroke

xBiotech 宣佈首次受試者參加中風新候選療法 Hutrukin 的 I 期臨床試驗
GlobeNewswire ·  2023/04/17 21:08

Hutrukin, A Therapy Discovered and Manufactured at XBiotech, Is Aimed to Reduce Brain Injury after Stroke

Hutrukin是xBiotech發現和製造的一種療法,旨在減少中風後的腦損傷

AUSTIN, Texas, April 17, 2023 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) has enrolled the first subject in a randomized, open-label, placebo-controlled dose escalation clinical study to evaluate safety and pharmacokinetics of Hutrukin.

德克薩斯州奧斯汀,2023年4月17日(GLOBE NEWSWIRE)——xBiote Inc.(納斯達克股票代碼:XBIT)已在一項隨機、開放標籤、安慰劑對照劑量遞增臨床研究中註冊了第一名受試者,該研究旨在評估Hutrukin的安全性和藥代動力學。

Hutrukin is being developed as a novel treatment to reduce brain injury following ischemic stroke. There are more than 10 million ischemic strokes each year—the leading cause of death and morbidity in the world today. An ischemic stroke occurs when a blood clot forms in a blood vessel that supplies blood flow to brain. Blockage of blood flow to the brain results in brain injury, loss of brain function or death.

Hutrukin作爲一種減少缺血性中風後腦損傷的新療法正在開發中。每年有超過1000萬例缺血性中風,這是當今世界的主要死亡和發病原因。當向大腦提供血液的血管中形成血塊時,就會發生缺血性中風。阻塞流向大腦的血液會導致腦損傷、腦功能喪失或死亡。

Emergency use of "clot-busting" drugs or mechanical catheters to re-open arteries after a stroke is associated with a phenomenon known as reperfusion injury. Reperfusion injury is where the return of blood supply after removing the clot from the artery results in increased brain injury or death. Reperfusion injury is believed to be the result of a massive inflammatory response caused by blood cells as they flow back into the region of the brain that was deprived of blood supply (and oxygen).

中風後緊急使用 “破壞血塊” 的藥物或機械導管重新開放動脈與一種現象有關 再灌注損傷。再灌注損傷是指從動脈中切除血塊後血液供應的恢復會導致腦損傷或死亡人數增加。據信,再灌注損傷是血細胞流回被剝奪血液供應(和氧氣)的大腦區域時引起的大規模炎症反應的結果。

Hutrukin therapy is intended to be provided immediately prior to the clot-busting procedure, where the drug may reduce inflammatory injury associated with reperfusion. There is currently no drug known to be effective to reduce reperfusion injury. Hutrukin could, therefore, potentially represent a significant advance in the management of stroke patients.

Hutrukin療法旨在在血栓破壞手術之前立即提供,在這種手術中,該藥物可以減少與再灌注相關的炎症損傷。目前尚無已知可有效減少再灌注損傷的藥物。因此,Hutrukin可能代表中風患者管理的重大進步。

The current Phase I study will evaluate three dose levels of Hutrukin for safety and will measure the corresponding blood levels of Hutrukin with increasing doses. Findings will guide dosing and safety expectations for the next phase of studies.

當前的I期研究將評估Hutrukin的三個劑量水平以確保安全性,並將隨着劑量的增加測量Hutrukin的相應血液水平。研究結果將指導下一階段研究的劑量和安全預期。

About True Human Therapeutic Antibodies
XBiotech's True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech's True Human antibodies have the potential to harness the body's natural immunity to fight disease with increased safety, efficacy and tolerability.

關於真正的人類治療性抗體
xBiotech 的 True Human 抗體未經修改源自對某些疾病具有天然免疫力的個體。通過跨多個疾病領域的發現和臨床項目,xBiotech的True Human抗體有可能利用人體的自然免疫來對抗疾病,同時提高安全性、有效性和耐受性。

About XBiotech
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit .

關於 xBiotech
xBiotech是一家完全整合的全球生物科學公司,致力於開創基於其True Human專有技術的治療性抗體的發現、開發和商業化。xBiotech目前正在推進強大的抗體療法產品線,以重新定義腫瘤學、炎症性疾病和傳染病的護理標準。xBiotech總部位於德克薩斯州奧斯汀,還領導着創新的生物技術製造技術的開發,旨在更快、更具成本效益和靈活地生產全球患者迫切需要的新療法。欲瞭解更多信息,請訪問。

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,包括有關管理層信念和期望的聲明,這些信念和期望涉及重大風險和不確定性。在某些情況下,您可以通過 “可能”、“將”、“應該”、“可以”、“期望”、“計劃”、“考慮”、“預期”、“相信”、“估計”、“預測”、“項目”、“打算” 或 “繼續” 等術語或其他類似術語的否定詞來識別前瞻性陳述,儘管並非所有前瞻性陳述都包含這些識別性詞語。前瞻性陳述在預測未來業績和條件時受固有的風險和不確定性的影響,這些風險和條件可能導致實際結果與這些前瞻性陳述中的預測存在重大差異。這些風險和不確定性受我們在美國證券交易委員會某些文件的 “風險因素” 部分中規定的披露的約束。前瞻性陳述不能保證未來的業績,我們的實際經營業績、財務狀況和流動性以及我們運營所在行業的發展可能與本新聞稿中包含的前瞻性陳述存在重大差異。我們在本新聞稿中發表的任何前瞻性陳述僅代表截至本新聞稿發佈之日。在本新聞稿發佈之日之後,我們沒有義務更新我們的前瞻性陳述,無論是由於新信息、未來事件還是其他原因。

Contact

聯繫我們

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

魏文義
wwei@xbiotech.com
電話 512-386-2900


譯文內容由第三人軟體翻譯。


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