Disappearance of Decompensated Liver Cirrhosis Episodes After Treatment with Can-Fite's Namodenoson
Can-Fite BioPharma (NYSE American: CANF) reported significant clinical progress with its drug Namodenoson in treating decompensated liver cirrhosis under a compassionate use program. After 20 months of treatment, the patient showed notable improvements, including resolution of moderate ascites, no further gastrointestinal bleeding episodes, and decreased liver stiffness and globulin levels.
Dr. Ohad Etzion from Soroka Medical Center highlighted the drug's potential importance, given the treatment options currently available besides liver transplantation. The liver cirrhosis treatment market is projected to reach approximately $15 billion in the U.S. by 2030, addressing a global patient population of 10.6 million affected by decompensated cirrhosis as of 2017.
Can-Fite BioPharma (NYSE American: CANF) ha riportato progressi clinici significativi con il suo farmaco Namodenoson nel trattamento della cirrosi epatica decompensata nell'ambito di un programma di uso compassionevole. Dopo 20 mesi di trattamento, il paziente ha mostrato notevoli miglioramenti, tra cui la risoluzione di ascite moderata, l'assenza di ulteriori episodi di sanguinamento gastrointestinale e la riduzione della rigidità epatica e dei livelli di globulina.
Il Dr. Ohad Etzion del Soroka Medical Center ha sottolineato l'importanza potenziale del farmaco, considerando le opzioni di trattamento attualmente disponibili oltre al trapianto di fegato. Si prevede che il mercato del trattamento della cirrosi epatica raggiunga circa 15 miliardi di dollari negli Stati Uniti entro il 2030, affrontando una popolazione globale di pazienti di 10,6 milioni affetti da cirrosi decompensata nel 2017.
Can-Fite BioPharma (NYSE American: CANF) informó sobre avances clínicos significativos con su medicamento Namodenoson en el tratamiento de la cirrosis hepática descompensada bajo un programa de uso compasivo. Después de 20 meses de tratamiento, el paciente mostró mejoras notables, incluyendo la resolución de ascitis moderada, sin episodios adicionales de sangrado gastrointestinal y con disminución de la rigidez hepática y los niveles de globulina.
El Dr. Ohad Etzion del Centro Médico Soroka destacó la importancia potencial del medicamento, considerando las opciones de tratamiento actualmente disponibles además del trasplante de hígado. Se proyecta que el mercado de tratamiento de la cirrosis hepática alcance aproximadamente 15 mil millones de dólares en EE. UU. para 2030, abordando una población global de pacientes de 10,6 millones afectados por cirrosis descompensada en 2017.
Can-Fite BioPharma (NYSE American: CANF)는 연민 사용 프로그램에 따라 간경변증의 탈 보상형 치료에 대한 Namodenoson 약물의 중요한 임상 진행 상황을 보고했습니다. 20개월의 치료 후, 환자는 중등도 복수의 해결, 추가적인 위장 출혈 에피소드 없음, 간 경직도 및 글로불린 수치 감소 등 눈에 띄는 개선을 보였습니다.
소로카 의료 센터의 오하드 에지온 박사는 간 이식 외에 현재 이용 가능한 치료 옵션을 고려할 때 이 약물의 잠재적 중요성을 강조했습니다. 간경변증 치료 시장은 2030년까지 미국에서 약 150억 달러에 이를 것으로 예상되며, 2017년 기준으로 탈 보상형 간경변증에 영향을 받은 1,060만 명의 글로벌 환자 인구를 다루고 있습니다.
Can-Fite BioPharma (NYSE American: CANF) a rapporté des progrès cliniques significatifs avec son médicament Namodenoson dans le traitement de la cirrhose hépatique décompensée dans le cadre d'un programme d'utilisation compassionnelle. Après 20 mois de traitement, le patient a montré des améliorations notables, notamment la résolution d'une ascite modérée, l'absence d'autres épisodes de saignement gastro-intestinal et une diminution de la rigidité hépatique et des niveaux de globuline.
Le Dr Ohad Etzion du Centre Médical Soroka a souligné l'importance potentielle du médicament, compte tenu des options de traitement actuellement disponibles en dehors de la transplantation hépatique. Le marché du traitement de la cirrhose hépatique devrait atteindre environ 15 milliards de dollars aux États-Unis d'ici 2030, en s'attaquant à une population mondiale de 10,6 millions de patients touchés par la cirrhose décompensée en 2017.
Can-Fite BioPharma (NYSE American: CANF) berichtete über bedeutende klinische Fortschritte mit seinem Medikament Namodenoson zur Behandlung von dekompensierter Leberzirrhose im Rahmen eines mitfühlenden Nutzungsprogramms. Nach 20 Monaten Behandlung zeigte der Patient bemerkenswerte Verbesserungen, darunter die Behebung einer moderaten Aszites, keine weiteren gastrointestinalen Blutungsepisoden und eine verringerte Lebersteifheit sowie Globulinwerte.
Dr. Ohad Etzion vom Soroka Medical Center hob die potenzielle Bedeutung des Medikaments hervor, angesichts der derzeit verfügbaren Behandlungsoptionen neben der Lebertransplantation. Der Markt für die Behandlung von Leberzirrhose wird voraussichtlich bis 2030 in den USA etwa 15 Milliarden Dollar erreichen und eine globale Patientenzahl von 10,6 Millionen adressieren, die 2017 von dekompensierter Zirrhose betroffen waren.
- Patient showed significant clinical improvement after 20 months of Namodenoson treatment
- Resolution of moderate ascites and elimination of need for diuretics
- No recurrence of gastrointestinal bleeding episodes
- Reduction in liver stiffness and globulin levels
- Addressing a large market opportunity of $15 billion by 2030 in the U.S.
- Drug still in compassionate use program, not yet FDA approved
- Results based on single patient case study only
Insights
The clinical results from Can-Fite's Namodenoson represent a potentially significant breakthrough in the treatment of decompensated liver cirrhosis. The observed improvements in multiple key disease markers are particularly noteworthy:
- Resolution of moderate ascites and elimination of diuretic dependency, indicating improved liver function and portal hypertension management
- Cessation of gastrointestinal bleeding episodes, suggesting better control of portal hypertension-related complications
- Reduction in liver stiffness and globulin levels, potentially indicating disease stabilization or regression
These outcomes are remarkable given that decompensated cirrhosis typically follows a progressive course with therapeutic options. The $15 billion market projection by 2030 underscores the significant commercial opportunity, but more importantly, reflects the massive unmet medical need in this space.
However, several critical considerations warrant attention. This is a single-patient compassionate use case, and while the results are encouraging, broader clinical validation through controlled trials will be essential. The 20-month duration of sustained improvement is promising, as it suggests potential long-term efficacy rather than temporary symptom relief.
From a market perspective, Namodenoson could potentially occupy a unique position in the treatment paradigm. Currently, patients with decompensated cirrhosis face a challenging prognosis, with many succumbing to their disease while waiting for liver transplantation. A therapy that can stabilize or improve their condition could serve as a critical bridge to transplantation or possibly even delay the need for transplantation in some patients.
The impact on healthcare economics could be substantial. Reducing complications, eliminating the need for diuretics, and potentially decreasing hospitalization rates could translate into significant cost savings for healthcare systems, while improving patient quality of life and survival prospects.
Liver cirrhosis treatment market is estimated to reach approximately
Ramat Gan, Israel, Feb. 18, 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 a significant clinical development: the disappearance of episodes of decompensated liver cirrhosis following treatment with Namodenoson under a compassionate use program. Decompensated liver cirrhosis, an advanced stage of cirrhosis often associated with liver failure, currently has no approved therapeutic options other than liver transplantation.
At 20 months into treatment, the patient reports notable improvements in symptoms related to the disease, such as fatigue and edema. Prior to starting Namodenoson, the patient had experienced an episode of esophageal variceal bleeding, but no further gastrointestinal bleeding episodes have occurred since beginning therapy. Additionally, moderate ascites that were present before treatment have gradually resolved, with the patient now off diuretics for over a year. Liver stiffness, measured repeatedly during the course of treatment, shows a mean decline compared to levels recorded before therapy began. Importantly, elevated globulin levels – a marker of advanced liver disease – have also started to decrease.
Dr. Ohad Etzion, Chief of Gastrointestinal and Liver Diseases at Soroka Medical Center in Israel, commented, "The patient's positive response to Namodenoson is extremely encouraging. We currently have very limited options for treating patients with decompensated liver disease beyond liver transplantation. Unfortunately, due to a shortage of donor organs, many patients die while waiting for a transplant. Namodenoson may offer a potential solution by stabilizing the disease and providing patients with precious time until a transplant becomes available."
In 2017, an estimated 10.6 million people globally were affected by decompensated cirrhosis, and the available treatment options remain scarce, especially for patients who have reached the advanced stages of the disease. Highlighting the urgent need for new therapies, the American Liver Foundation has stated that there are more patients in need of a liver transplant than available organs, with some patients waiting over five years for a transplant. The U.S. market for liver cirrhosis treatment is projected to grow to approximately
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
What clinical improvements were observed in the CANF Namodenoson compassionate use case?
What is the market size potential for CANF's liver cirrhosis treatment?
How many people globally are affected by decompensated cirrhosis according to CANF's report?
What are the current treatment options for decompensated liver cirrhosis besides CANF's Namodenoson?
How long was the patient treated with CANF's Namodenoson before showing improvements?
