Improvement in Patient With Decompensated Liver Cirrhosis Upon Treatment With Namodenoson
Improvement in Patient With Decompensated Liver Cirrhosis Upon Treatment With Namodenoson
Liver cirrhosis treatment global market is estimated to reach $29.2 billion by 2030
到2030年,全球肝硬化治療市場預計將達到292億美元
Ramat Gan, Israel, July 01, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, announced today that a patient with liver decompensated cirrhosis who was treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use showed an improvement in liver indices. This drug candidate is currently used in a pivotal Phase III study for patients with advanced liver cancer and a Phase IIb study for MASH (metabolic dysfunction-associated steatohepatitis).
以色列拉馬特甘,2024年7月01日(全球新聞社)--can-fite biopharma生物技術公司Can-Fite(紐交所美國:CANF,TASE:CFBI)擁有一系列旨在治療腫瘤和炎症性疾病的專有小分子藥物,今天宣佈,在以色列索洛卡醫學中心進行同情使用的Namodenoson治療的肝失代償性肝硬化患者顯示了肝功能指標的改善。這種藥物候選目前被用於對付晚期肝癌的關鍵三期研究和MASH(代謝障礙相關脂肪肝炎)的二期b研究。
Decompensated cirrhosis is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression.
失代償性肝硬化定義爲肝硬化患者肝功能急劇惡化,其特徵爲黃疸,腹水,肝性腦病,肝腎綜合症或靜脈曲張出血。雖然一些藥物可以治療症狀,但目前沒有治療方法證明其能夠有效減緩疾病的進展。
In the past year Can-Fite has initiated a compassionate use program at the Soroka Medical Center, Beersheva, Israel, for the treatment of decompensated patients with Namodenoson. The first patient, a 63-year-old female with a history of decompensated primary biliary cirrhosis is now treated for one year with Namodenoson. Prior to the treatment with Namodenoson and despite best medical care for her underlying disease, she developed ascites and was admitted to the hospital with acute variceal bleeding. Currently, the patient shows improvement in liver function tests hematological parameters and FibroScan values and has not experienced any event of decompensation since starting treatment with Namodenoson. Namodenoson is known to induce liver protective effects in other liver pathologies, and Phase IIa data in patients suffering from MASH (metabolic dysfunction-associated steatohepatitis), responded positively to the drug, showing anti-inflammatory, anti-steatotic, and antifibrotic effects with a very favorable safety profile.
在過去的一年裏,Can-Fite在以色列Beer Sheva索洛卡醫療中心啓動了一個同情使用計劃,用於治療失代償患者的Namodenoson。第一位患者是一位63歲的女性,曾患失代償性原發性膽汁性肝硬化,並接受了一年的Namodenoson治療。在接受Namodenoson治療之前,儘管其患有潛在疾病的最佳醫學護理,但她發展出腹水並因急性靜脈曲張出血而入院治療。目前,該患者在接受Namodenoson治療後,肝功能測試,血液學參數和FibroScan值均有所改善,並且自開始治療以來沒有經歷失代償事件。Namodenoson已被證明在其他肝病中具有誘導肝保護作用,並且對患有MASH(代謝障礙相關脂肪肝炎)的患者的IIa期數據對藥物作出了積極反應,顯示出具有很好安全性的抗炎,抗脂肪肝和抗纖維化作用。
Ohad Etzion, MD, Director, Department of Gastroenterology and Liver Diseases at the Soroka Medical Center, Beer Sheva, Israel, the Investigator and Initiator of this study commented, "We were very much encouraged by the response of the first patient with decompensated liver cirrhosis who showed a rapid and sustained response to the drug with an improvement with liver indices. We plan to treat more patients and hopefully see an improvement of liver function in this devastating disease.
我非常鼓舞對於第一位患有失代償性肝硬化的患者所顯示的快速和持續的藥物反應,並且肝指標得到了改善。我們計劃治療更多患者,並希望在這種毀滅性疾病的肝功能方面看到改善。"/
Decompensated cirrhosis is defined as an acute deterioration in liver function, with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression. An estimated 10.6 million people globally had decompensated cirrhosis in 2017, with few treatment options available aside from liver transplants if the decompensated cirrhosis has reached an advanced stage. Underscoring the need for an effective treatment, the American Liver Foundation states there are more people who need a liver than supply available, and some people can be on the wait list for a liver transplant for more than 5 years. The treatment of liver cirrhosis globally is estimated to become an approximately $29.2 billion market by 2031.
失代償肝硬化2017年全球估計有1060萬患者,除非失代償性肝硬化已達到晚期,否則幾乎沒有治療選項可用。美國肝臟基金會強調需要有效的治療方案,因爲需要肝臟的人比有供應的人更多,一些人可能需要等待超過5年等待肝移植。全球肝硬化治療市場的市場規模預計將在2031年左右達到292億美元。10.6百萬美國肝臟基金會Can-Fite BioPharma Ltd.(紐交所美國:CANF,TASE:CANF)是一家擁有平台技術的公司,旨在治療腫瘤,肝臟和炎症性疾病,目前處於先進臨床階段。該公司的首席藥物候選品Piclidenoson最近在治療牛皮癬的三期試驗中報告了結果,並有望開始關鍵的三期試驗。Can-Fite的肝臟腫瘤藥物Namodenoson正在進行對於代謝失調相關脂肪肝炎(MASH)的二期b試驗,肝細胞癌(HCC)的三期關鍵試驗,並計劃在胰腺癌的IIa期研究中進行研究。 Namodenoson已獲得美國和歐洲的孤兒藥物認證,並被美國食品和藥物管理局授予用於HCC二線治療的快速通道認證。 Namodenoson還顯示潛力以治療其他癌症,包括結腸癌,前列腺癌和黑色素瘤。該公司的第三個藥物候選品CF602在治療勃起功能障礙方面顯示出功效。迄今爲止,這些藥物在1600名患者的臨床研究中具有優異的安全性。欲知更多信息,請訪問:全球肝硬化治療的市場規模估計將在2031年左右達到292億美元。$29.2億美元市場。
About Namodenoson
關於Namodenoson:Namodenoson是一種小口服藥物,與A3腺苷受體(A3AR)高親和力和選擇性結合。Namodenoson針對的化學樣品A3AR在疾病細胞中高表達,在正常細胞中低表達。這種差異效應解釋了該藥物的優異安全性。Namodenoson在兩個適應症的2期試驗中得到評估,在肝細胞癌的二線治療和非酒精性脂肪性肝病(NAFLD)和非酒精性脂肪性肝炎(NASH)治療中。
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
Namodenoson是一種小分子口服藥物,與A3腺苷受體(A3AR)具有高親和力和選擇性結合。Namodenoson已在兩個臨床二期試驗中評估,一個是作爲肝細胞肝癌的二線治療,另一個是作爲治療代謝失調相關脂肪肝炎(MASH)的藥物。A3AR在患病細胞中高度表達,而在正常細胞中發現低表達。這種差異效應解釋了藥物的良好安全性。
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd.(NYSE:CANF)(TASE:CANF)是一家先進的臨床階段藥物開發公司,擁有設計用於治療肝癌和炎症性疾病的多十億美元市場的平台技術。公司的核心藥物候選,Piclidenoson,最近在牛皮癬第3期試驗中報告了業績排名,並有望開始關鍵性第3期。Can-Fite的肝癌和肝臟藥物Namodenoson正在評估治療代謝性功能障礙相關脂肪肝病(MASH)等級的2b期試驗,正在進行用於肝細胞癌(HCC)的第3期關鍵性試驗,公司正在規劃胰腺癌的2a期研究。Namodenoson已獲得美國和歐洲的孤兒藥指定,並被美國食品和藥品管理局授予作爲HCC的二線治療快速通道。Namodenoson還顯示了概念證明,有可能治療其他癌症,包括結腸癌、前列腺癌和黑色素瘤。公司的第三種藥物候選CF602,在治療勃起功能障礙方面表現出有效性。這些藥物在臨床研究中已經在超過1600名患者中得到了極好的安全性評價。有關更多信息,請訪問公司網站。
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: .
Can-Fite BioPharma Ltd.(紐交所美國:CANF,TASE:CANF)是一家擁有平台技術的公司,旨在治療腫瘤,肝臟和炎症性疾病。該公司的首席藥物候選品Piclidenoson最近在治療牛皮癬的三期試驗中報告了結果,並有望開始關鍵的三期試驗。 Can-Fite的肝臟腫瘤藥物Namodenoson正在進行對於代謝失調相關脂肪肝炎(MASH)的二期b試驗,肝細胞癌(HCC)的三期關鍵試驗,並計劃在胰腺癌的IIa期研究中進行研究。 Namodenoson已獲得美國和歐洲的孤兒藥物認證,並被美國食品和藥物管理局授予用於HCC二線治療的快速通道認證。 Namodenoson還顯示潛力以治療其他癌症,包括結腸癌,前列腺癌和黑色素瘤。該公司的第三個藥物候選品CF602在治療勃起功能障礙方面顯示出功效。迄今爲止,這些藥物在1600名患者的臨床研究中具有優異的安全性。欲知更多信息,請訪問:.
Forward-Looking Statements
前瞻性聲明
This press release may contain forward-looking statements, about Can-Fite's expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are "forward looking statements". Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the "Risk Factors" section of Can-Fite's Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
本新聞稿可能包含關於Can-Fite所期望、信奉或打算的前瞻性聲明,涉及產品開發努力、業務、財務狀況、經營業績、戰略或前景等方面的內容。此處的所有聲明都是“前瞻性聲明”,並非公司歷史事實的關聯。前瞻性聲明可以通過使用前瞻性語言,例如“相信”、“期望”、“打算”、“計劃”、“可能”、“應該”或“預期”或它們的否定或這些詞或其他可比較的詞的變體來確定,並非嚴格與歷史或當前事實相關的陳述。前瞻性聲明涉及到作爲它們做出日期的預期或預期的事件、活動、趨勢或結果。由於前瞻性聲明涉及到尚未發生的事項,這些聲明本質上承擔着已知和未知的風險、不確定性和其他因素,這些因素可能導致Can-Fite的實際結果、業績或成就與任何未來結果、業績或成就在前瞻性聲明中表現的結果、業績或成就本質上不同。這些風險、不確定性和其他因素的重要因素包括我們的虧損歷史和需要額外資金來資助經營活動和我們無法獲得任何資本的需要或不能獲得接受的條款或完全沒有額外資本;現金流和無法滿足營運需求的不確定性;我們的臨床前研究、臨床試驗和其他產品候選開發努力的啓動、時間、進展和結果;我們能夠將我們的產品候選進入臨床試驗或成功完成我們的臨床前研究或臨床試驗的能力;我們的產品候選在獲得監管批准和其他監管申請和批准的時間;我們的產品候選的臨床開發、商業化和市場接受度;我們能夠建立和維護戰略伙伴關係和其他公司企業合作關係;我們的商業模式和企業和產品候選的戰略計劃的實施;我們能夠爲涵蓋我們的產品候選的知識產權權利建立和維護範圍,並在不侵犯他人知識產權權利的情況下運作我們的業務;我們行業內的競爭公司、技術和;與COVID-19大流行的復甦和以色列與哈馬斯之間的戰爭有關的風險;與無法滿足紐約證券交易所美國公司持續上市要求的風險有關;以及有關以色列政治和安全形勢對我們業務的影響的聲明。更多關於這些風險、不確定性和其他因素的信息包括Can-Fite關於2024年3月28日提交給美國證券交易委員會的20-F年度報告以及向TASE提交的其他公開報告中的“風險因素”部分和其定期提交文件中。現有和潛在的投資者被告知不要過分依賴這些前瞻性聲明,這些前瞻性聲明僅作本新聞稿發出之日的陳述。Can-Fite不承擔公開更新或複審任何前瞻性陳述的義務,無論是因爲新信息、未來發展或其他原因,除非任何適用證券法律所要求的。
Contact
聯繫人
Can-Fite BioPharma
can-fite biopharma
Motti Farbstein
Motti Farbstein
info@canfite.com
info@canfite.com
+972-3-9241114
+972-3-9241114