Can-Fite Innovative Publication: Namodenoson in Liver Cancer Treatment Alongside with Cardiac, Liver, and Neurological Benefits
Can-Fite BioPharma (NYSE: CANF) announced the publication of an innovative study in the European Society of Medicine Journal highlighting the protective effects of Namodenoson in liver cancer treatment. The study, conducted in collaboration with hepatologists from Soroka University Medical Center, demonstrates the drug's anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity properties across multiple body systems.
Unlike conventional chemotherapy, Namodenoson shows protective effects on the liver, central nervous system, and cardiovascular system by increasing adiponectin levels. The drug is currently in a pivotal Phase III study (LiverationTM) for advanced liver cancer, with both FDA and EMA approval. Notably, Namodenoson has received Orphan Drug status from both agencies and Fast Track status from the FDA.
Can-Fite BioPharma (NYSE: CANF) ha annunciato la pubblicazione di uno studio innovativo nella rivista European Society of Medicine Journal, evidenziando gli effetti protettivi di Namodenoson nel trattamento del cancro al fegato. Lo studio, condotto in collaborazione con epatologi del Soroka University Medical Center, dimostra le proprietà anti-ischemiche, anti-infiammatorie, anti-fibrotiche e anti-tossiche del farmaco su più sistemi corporei.
Contrariamente alla chemioterapia convenzionale, Namodenoson mostra effetti protettivi sul fegato, sul sistema nervoso centrale e sul sistema cardiovascolare aumentando i livelli di adiponectina. Il farmaco è attualmente in uno studio clinico cruciale di Fase III (LiverationTM) per il cancro al fegato avanzato, con approvazione sia della FDA che dell'EMA. È importante notare che Namodenoson ha ricevuto lo status di Farmaco Orfano da entrambe le agenzie e lo status di Fast Track dalla FDA.
Can-Fite BioPharma (NYSE: CANF) anunció la publicación de un estudio innovador en la revista European Society of Medicine Journal que destaca los efectos protectores de Namodenoson en el tratamiento del cáncer de hígado. El estudio, realizado en colaboración con hepatólogos del Soroka University Medical Center, demuestra las propiedades anti-isquémicas, anti-inflamatorias, anti-fibróticas y anti-toxicidad del fármaco en múltiples sistemas del cuerpo.
A diferencia de la quimioterapia convencional, Namodenoson muestra efectos protectores en el hígado, el sistema nervioso central y el sistema cardiovascular al aumentar los niveles de adiponectina. El fármaco se encuentra actualmente en un estudio pivotal de Fase III (LiverationTM) para el cáncer de hígado avanzado, con aprobación tanto de la FDA como de la EMA. Cabe destacar que Namodenoson ha recibido el estatus de Medicamento Huérfano de ambas agencias y el estatus de Vía Rápida de la FDA.
Can-Fite BioPharma (NYSE: CANF)는 간암 치료에서 Namodenoson의 보호 효과를 강조하는 혁신적인 연구 결과를 European Society of Medicine Journal에 발표했다고 발표했습니다. 이 연구는 Soroka University Medical Center의 간 전문의들과 협력하여 수행되었으며, 약물의 항허혈, 항염증, 항섬유화 및 항독성 특성을 여러 신체 시스템에서 입증합니다.
전통적인 화학요법과 달리, Namodenoson은 아디포넥틴 수치를 증가시켜 간, 중추 신경계 및 심혈관계에 보호 효과를 보여줍니다. 이 약물은 현재 진행 중인 중요한 3상 연구(LiverationTM)에 있으며, FDA와 EMA의 승인을 받았습니다. 특히, Namodenoson은 두 기관 모두에서 희귀의약품 지위와 FDA로부터 신속 심사 지위를 받았습니다.
Can-Fite BioPharma (NYSE: CANF) a annoncé la publication d'une étude innovante dans le European Society of Medicine Journal, mettant en avant les effets protecteurs de Namodenoson dans le traitement du cancer du foie. L'étude, réalisée en collaboration avec des hépatologues du Soroka University Medical Center, démontre les propriétés anti-ischémiques, anti-inflammatoires, anti-fibrotiques et anti-toxicité du médicament à travers plusieurs systèmes corporels.
Contrairement à la chimiothérapie conventionnelle, Namodenoson montre des effets protecteurs sur le foie, le système nerveux central et le système cardiovasculaire en augmentant les niveaux d'adiponectine. Le médicament est actuellement en étude pivot de Phase III (LiverationTM) pour le cancer du foie avancé, avec l'approbation de la FDA et de l'EMA. Il est à noter que Namodenoson a reçu le statut de médicament orphelin de la part des deux agences et le statut Fast Track de la FDA.
Can-Fite BioPharma (NYSE: CANF) gab die Veröffentlichung einer innovativen Studie in der European Society of Medicine Journal bekannt, die die schützenden Wirkungen von Namodenoson bei der Behandlung von Leberkrebs hervorhebt. Die Studie, die in Zusammenarbeit mit Hepatologen des Soroka University Medical Center durchgeführt wurde, zeigt die anti-ischämischen, entzündungshemmenden, anti-fibrotischen und anti-toxischen Eigenschaften des Medikaments in mehreren Körpersystemen.
Im Gegensatz zur herkömmlichen Chemotherapie zeigt Namodenoson schützende Wirkungen auf die Leber, das zentrale Nervensystem und das Herz-Kreislauf-System, indem es die Adiponektinwerte erhöht. Das Medikament befindet sich derzeit in einer entscheidenden Phase-III-Studie (LiverationTM) für fortgeschrittenen Leberkrebs, mit Genehmigung sowohl der FDA als auch der EMA. Bemerkenswert ist, dass Namodenoson von beiden Behörden den Status eines Orphan Drug und von der FDA den Fast Track Status erhalten hat.
- Drug shows dual benefit: anti-cancer + protective effects on healthy tissue
- Phase III trial approved by both FDA and EMA
- Received Fast Track and Orphan Drug designations
- Demonstrated protective effects across multiple organ systems
- Phase III trial results still pending
- No efficacy or safety data from current trials disclosed
Insights
This publication represents a significant scientific advancement for Can-Fite's lead candidate Namodenoson. The research highlights a critical differentiator from traditional cancer treatments by demonstrating protective effects across multiple organ systems while maintaining anti-cancer properties.
What's particularly noteworthy is the mechanistic insight - Namodenoson's ability to increase adiponectin levels provides a scientific basis for its multi-organ protective effects. This mechanism helps explain how the drug can target cancer while simultaneously protecting healthy tissues, addressing one of oncology's greatest challenges.
From a clinical development perspective, Namodenoson's current position in a Phase III pivotal trial for advanced liver cancer (LiverationTM) places it in late-stage development. The combination of FDA Fast Track designation and Orphan Drug status from both FDA and EMA indicates regulatory recognition of both unmet need and therapeutic potential.
For a microcap biotech with approximately
Can-Fite's publication strengthens the scientific narrative around Namodenoson by establishing its mechanistic differentiation through adiponectin modulation. This creates a compelling scientific and potential commercial distinction from existing hepatocellular carcinoma treatments, which typically cause significant toxicity issues.
The liver cancer market represents a substantial opportunity due to poor prognosis and treatment options. Current first-line standards like Nexavar (sorafenib) generate hundreds of millions in annual sales despite modest survival benefits and significant side effects. A treatment offering comparable efficacy with improved safety would have clear market advantages.
From a regulatory standpoint, the combination of Fast Track designation and Orphan Drug status creates potential for accelerated approval pathways and extended market exclusivity. These designations typically enhance biotechnology asset valuations, particularly in small-cap companies where a single late-stage asset can drive significant valuation changes.
While the scientific publication itself doesn't change the fundamental clinical development timeline, it adds credibility to Can-Fite's approach before pivotal trial results. For a company with
Unlike chemotherapy with its known toxicity towards normal body systems, Namodenoson provides protective effects
Ramat Gan, Israel, March 03, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that the European Society of Medicine Journal published an innovative article titled: “The Neuro- Cardio- and Hepato- Protective Effects of Namodenoson are Mediated by Adiponectin”. The study is the result of a collaboration between Can-Fite scientists and leading hepatologists from the Department of Gastroenterology and Liver Diseases at Soroka University Medical Center, Beer Sheva, Israel.
The article presents compelling preclinical and clinical data demonstrating Namodenoson’s potent anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity effects across multiple body tissues including the liver, central nervous system, and cardiovascular system. The study highlights Namodenoson’s ability to increase adiponectin levels, a key cytokine known to drive multi-organ protective effects. Importantly, the manuscript underscores Namodenoson’s dual role as both an anti-cancer therapy and a protective agent for normal tissues, setting it apart from conventional chemotherapy and other oncology treatments with significant toxicity.
Dr. Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “The data published in this journal further supports Namodenoson’s unique profile as an anti-cancer drug that simultaneously safeguards healthy body systems. This critical distinction positions Namodenoson as a potential breakthrough therapy, unlike traditional chemotherapy, which is often associated with severe toxicity.
Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The drug has an Orphan Drug status with both FDA and EMA and a Fast Track status with the FDA.
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 recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. 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
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