Can-Fite: 9-Year Survival with Complete Cure in an Advanced Liver Cancer Patient Treated with Namodenoson
Can-Fite (NYSE American: CANF) reported that a patient with advanced hepatocellular carcinoma treated with Namodenoson reached 9 years overall survival with a complete response and remains cancer-free while on compassionate use treatment.
The company is enrolling a pivotal Phase III HCC study in Israel, Europe and the U.S.; the protocol was agreed with the FDA and EMA. Namodenoson holds Orphan Drug status from both agencies and Fast Track status from the FDA. A compassionate use program is active in Israel and Romania.
Can-Fite (NYSE American: CANF) ha riferito che un paziente con carcinoma epatocellulare avanzato trattato con Namodenoson ha raggiunto 9 anni di sopravvivenza globale con una risposta completa e resta libero da cancro mentre è in trattamento di uso compassionevole.
L'azienda sta reclutando uno studio cruciale di fase III sull'HCC in Israele, Europa e negli Stati Uniti; il protocollo è stato concordato con la FDA e l'EMA. Namodenoson possiede lo status di Orphan Drug (Orphan Drug) da entrambe le agenzie e lo status di Fast Track dalla FDA. Un programma di uso compassionevole è attivo in Israele e Romania.
Can-Fite (NYSE American: CANF) informó que un paciente con carcinoma hepatocelular avanzado tratado con Namodenoson alcanzó 9 años de supervivencia global con una respuesta completa y continúa libre de cáncer mientras recibe tratamiento de uso compasivo.
La empresa está reclutando un estudio pivotal de fase III de HCC en Israel, Europa y Estados Unidos; el protocolo fue acordado con la FDA y la EMA. Namodenoson tiene estatus de Orphan Drug de ambas agencias y estatus de Fast Track de la FDA. Un programa de uso compasivo está activo en Israel y Rumania.
Can-Fite (NYSE American: CANF)은 진행성 간세포암(HCC) 환자가 Namodenoson으로 치료받아 전체 생존 9년에 도달했고 완전 반응을 보였으며, 동정적 사용 치료 중에도 암이 없는 상태를 유지하고 있다고 보고했습니다.
회사는 이스라엘, 유럽 및 미국에서 Phase III HCC 연구의 결정적(주요) 시험을 모집 중이며, 프로토콜은 FDA와 EMA와 합의되었습니다. Namodenoson은 두 기관으로부터 Orphan Drug 지위를 보유하고 Fast Track 지위를 FDA로부터 받았습니다. 이스라엘과 루마니아에서 동정적 사용 프로그램이 활성화되어 있습니다.
Can-Fite (NYSE American: CANF) a déclaré qu'un patient atteint d'un carcinome hépatocellulaire avancé traité par Namodenoson a atteint 9 ans de survie globale avec une réponse complète et demeure libre de cancer sous traitement d'usage compassionnel.
L'entreprise recrute une étude pivot Phase III sur le HCC en Israël, en Europe et aux États-Unis; le protocole a été convenu avec la FDA et l'EMA. Namodenoson bénéficie du statut Orphan Drug des deux agences et du statut Fast Track de la FDA. Un programme d'usage compassionnel est actif en Israël et en Roumanie.
Can-Fite (NYSE American: CANF) berichtete, dass ein Patient mit fortgeschrittenem hepatozellulärem Karzinom, der mit Namodenoson behandelt wurde, 9 Jahre Gesamtüberleben erreichte, eine komplette Ansprechrate zeigte und unter der Behandlung mit einem Compassionate-Use-Programm krebsfrei bleibt.
Das Unternehmen rekrutiert eine zentrale Phase-III HCC-Studie in Israel, Europa und den USA; das Protokoll wurde mit der FDA und der EMA vereinbart. Namodenoson trägt den Status Orphan Drug von beiden Behörden und den Status Fast Track von der FDA. Ein Compassionate-Use-Programm ist in Israel und Rumänien aktiv.
Can-Fite (NYSE American: CANF) ذكرت أن مريضاً مصاباً بسرطان الكبد الخبيث المتقدم المعالج بـ Namodenoson وصل إلى 9 سنوات من البقاء على قيد الحياة الإجمالي مع استجابة كاملة وما يزال خالياً من السرطان أثناء العلاج في إطار استخدام رحيم/عناية بالشفقة.
الشركة تجري حالياً دراسة حاسمة من المرحلة III لـ HCC في إسرائيل وأوروبا والولايات المتحدة؛ تم الاتفاق على البروتوكول مع FDA وEMA. Namodenoson يحمل حالتي Orphan Drug من كلا الجهتين وحالة Fast Track من FDA. برنامج استخدام رحيم متاح في إسرائيل ورومانيا.
- 9-year overall survival with complete response in one advanced HCC patient
- Phase III pivotal trial enrolling in Israel, Europe and U.S.
- Regulatory designations: Orphan Drug (FDA, EMA) and FDA Fast Track
- Single-patient result from prior Phase II; not evidence of broad efficacy
Insights
Single long‑term complete response reported; promising but anecdotal, with pivotal Phase III now enrolling under agreed regulatory protocols.
Namodenoson shows an unusually durable complete response in one advanced hepatocellular carcinoma patient, reported on
The business mechanism is straightforward: a single, exceptional long‑term responder can support scientific interest and help recruitment, but it does not establish efficacy for the broader population. Key dependencies include reproducibility in the randomized Phase III endpoints and adequate enrollment of the 2nd/3rd line HCC population. Main risks are that this is an isolated case from Phase II and compassionate use, so outcome generalizability is unknown and regulatory decisions will rely on controlled trial data.
Watch for enrollment pace and the Phase III primary endpoint results as the decisive evidence; also monitor any interim analyses, safety signals, and formal regulatory interactions. The reported durable response and existing regulatory designations are meaningful context, but confirmation requires the completed pivotal trial within the standard clinical development timeframe.
Pivotal Phase III liver cancer study enrolling in Europe and Israel
RAMAT GAN, Israel, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, announced today that a patient treated with Namodenoson has reached an overall survival of 9 years to date with complete response to treatment.
The patient, who suffered from advanced liver cancer, was enrolled in Can-Fite’s completed Phase II study and continues to be treated with Namodenoson through a compassionate use program. Nine years following treatment, the patient remains cancer-free and meets the definition of a complete responder based on the disappearance of ascites, normal liver function, and good quality of life.
Can-Fite is currently enrolling patients in Israel, Europe, and the U.S. for a pivotal Phase III clinical study of Namodenoson for patients with advanced hepatocellular carcinoma (HCC), the common form of liver cancer, as a 2nd or 3rd line treatment. The study protocol has been agreed upon with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.
“With Namodenoson’s potent anti-cancer activity, along with its excellent tolerability, we aim to deliver longer survival for patients and hope to see outcomes that mirror the exceptional 9 year response achieved by the long-treated patient from our prior Phase II study. Namodenoson’s highly selective action against tumor cells, combined with its protection of healthy liver tissue, has the potential to make our Phase III trial especially promising,” stated Prof. Pnina Fishman, Can-Fite CSO & Chairperson.
According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.
About Can-Fite BioPharma Ltd.
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 reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in 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: https://www.canfite.com/.
Forward-Looking Statements
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.
Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
FAQ
What is the reported outcome for the Namodenoson-treated HCC patient from Can-Fite (CANF)?
Is Can-Fite enrolling a Phase III trial for Namodenoson (CANF) and where?
Has the Namodenoson Phase III protocol (CANF) been agreed with regulators?
What regulatory designations does Namodenoson (CANF) have?
Where is Namodenoson available via compassionate use for CANF patients?
Does the 9-year cancer-free case prove Namodenoson will work for other HCC patients?
