8 Years Survival with Complete Cure for a Patient with Advanced Liver Cancer Being Treated with Can-Fite’s Namodenoson Drug
Can-Fite BioPharma (NYSE American: CANF) reported remarkable results from their compassionate use program, where a patient with advanced liver cancer treated with Namodenoson has achieved an 8-year survival with complete response. The patient experienced disappearance of ascites, normal liver function, and good quality of life.
The company is currently enrolling patients in Israel, Europe, and the US for a pivotal Phase III clinical study for advanced HCC as a 2nd or 3rd line treatment. Namodenoson, administered orally twice daily, has received Orphan Drug status from both FDA and EMA, along with FDA Fast Track Status for HCC treatment.
The liver cancer treatment market is projected to reach $6.1 billion by 2027 in G8 countries, with liver cancer causing over 700,000 deaths globally each year.
Can-Fite BioPharma (NYSE American: CANF) ha riportato risultati straordinari dal loro programma di uso compassionevole, dove un paziente con cancro epatico avanzato trattato con Namodenoson ha raggiunto una sopravvivenza di 8 anni con risposta completa. Il paziente ha sperimentato la scomparsa dell'ascite, funzioni epatiche normali e una buona qualità della vita.
L'azienda sta attualmente arruolando pazienti in Israele, Europa e Stati Uniti per uno studio clinico fondamentale di Fase III per HCC avanzato come trattamento di seconda o terza linea. Namodenoson, somministrato per via orale due volte al giorno, ha ricevuto lo stato di Farmaco Orfano sia dalla FDA che dall'EMA, insieme allo stato di Fast Track della FDA per il trattamento dell'HCC.
Il mercato del trattamento del cancro al fegato è previsto raggiungere 6,1 miliardi di dollari entro il 2027 nei paesi G8, con il cancro al fegato che causa oltre 700.000 decessi a livello globale ogni anno.
Can-Fite BioPharma (NYSE American: CANF) informó resultados notables de su programa de uso compasivo, donde un paciente con cáncer de hígado avanzado tratado con Namodenoson ha logrado una supervivencia de 8 años con respuesta completa. El paciente experimentó la desaparición de ascitis, función hepática normal y buena calidad de vida.
La empresa está actualmente reclutando pacientes en Israel, Europa y EE. UU. para un estudio clínico pivotal de Fase III para HCC avanzado como tratamiento de segunda o tercera línea. Namodenoson, administrado por vía oral dos veces al día, ha recibido el estatus de Medicamento Huérfano tanto de la FDA como de la EMA, junto con el estatus de Ruta Rápida de la FDA para el tratamiento de HCC.
Se proyecta que el mercado de tratamientos para el cáncer de hígado alcance 6,1 mil millones de dólares para 2027 en países del G8, siendo el cáncer de hígado responsable de más de 700,000 muertes globalmente cada año.
Can-Fite BioPharma (NYSE American: CANF)는 Namodenoson으로 치료받은 진행성 간암 환자가 완전 반응을 보이며 8년 생존을 달성한 효과적인 결과를 보고했습니다. 환자는 복수를 분리하고, 간 기능이 정상화되며, 좋은 삶의 질을 경험했습니다.
현재 이 회사는 이스라엘, 유럽 및 미국에서 두 번째 또는 세 번째 치료선으로서 진행성 HCC에 대한 3상 임상 연구에 환자를 모집하고 있습니다. Namodenoson은 하루 두 번 경구로 투여되며, FDA 및 EMA로부터 희귀의약품 지정을 받았고, HCC 치료를 위한 FDA의 신속진행 프로그램 지정을 받았습니다.
간암 치료 시장은 G8 국가에서 2027년까지 61억 달러에 이를 것으로 예상되며, 매년 전 세계적으로 70만 명 이상의 간암 사망자를 초래하고 있습니다.
Can-Fite BioPharma (NYSE American: CANF) a rapporté des résultats remarquables de son programme d'usage compassionnel, où un patient atteint d'un cancer du foie avancé traité avec Namodenoson a atteint une survie de 8 ans avec réponse complète. Le patient a connu la disparition de l'ascite, un fonctionnement hépatique normal et une bonne qualité de vie.
L'entreprise recrute actuellement des patients en Israël, en Europe et aux États-Unis pour une étude clinique de Phase III sur le HCC avancé comme traitement de deuxième ou troisième ligne. Namodenoson, administré par voie orale deux fois par jour, a reçu le statut de médicament orphan tant de la FDA que de l'EMA, ainsi que le statut Fast Track de la FDA pour le traitement du HCC.
Le marché des traitements contre le cancer du foie devrait atteindre 6,1 milliards de dollars d'ici 2027 dans les pays du G8, le cancer du foie causant chaque année plus de 700 000 décès dans le monde.
Can-Fite BioPharma (NYSE American: CANF) berichtete von bemerkenswerten Ergebnissen aus ihrem Programm zur einfühlsamen Anwendung, bei dem ein Patient mit fortgeschrittenem Leberkrebs, der mit Namodenoson behandelt wurde, eine 8-jährige Überlebenszeit mit kompletter Rückbildung erreicht hat. Der Patient erlebte das Verschwinden von Aszites, eine normale Leberfunktion und eine gute Lebensqualität.
Das Unternehmen rekrutiert derzeit Patienten in Israel, Europa und den USA für eine wegweisende Phase-III-Studie bei fortgeschrittenem HCC als 2. oder 3. Behandlungsoption. Namodenoson, das zweimal täglich oral verabreicht wird, hat den Status eines Orphan Drugs sowohl von der FDA als auch von der EMA erhalten, sowie den Status Fast Track von der FDA für die Behandlung von HCC.
Der Markt für Leberkrebsbehandlungen wird voraussichtlich bis 2027 6,1 Milliarden Dollar erreichen in den G8-Ländern, wobei Leberkrebs jedes Jahr weltweit über 700.000 Todesfälle verursacht.
- Single patient achieved 8-year survival with complete response in compassionate use program
- Namodenoson has both FDA and EMA Orphan Drug status
- FDA granted Fast Track Status for HCC treatment
- Large market potential with projected $6.1B market size by 2027 in G8 countries
- Results based on single patient case study, not broader clinical evidence
- Still in Phase III trials, no regulatory approval yet
Insights
The reported 8-year survival with complete response in an advanced liver cancer patient using Namodenoson is remarkably significant. This outcome is particularly noteworthy given that advanced hepatocellular carcinoma (HCC) typically has a poor prognosis with median survival often measured in months rather than years. The patient's reported improvements in key clinical markers - disappearance of ascites, normalized liver function and good quality of life - represent exceptional therapeutic outcomes.
The drug's dual mechanism of specifically targeting tumor cells while protecting normal liver tissue presents a unique therapeutic advantage. The ongoing Phase III trial, supported by both FDA and EMA with Orphan Drug and Fast Track designations, positions this development favorably in the regulatory pathway. With the global HCC treatment market projected at
This single patient case demonstrates exceptional therapeutic success in a notoriously difficult-to-treat cancer. Advanced HCC patients typically face treatment options and poor outcomes, making an 8-year survival with complete response highly unusual. The maintenance of normal liver function is particularly impressive, as liver function typically deteriorates in advanced HCC cases.
The oral administration route offers a significant advantage over more invasive treatments. The drug's safety profile, combined with its apparent efficacy in this case, suggests potential for both second and third-line treatment applications. However, it's important to note that while this individual case is promising, the ongoing Phase III trial will be important in determining whether these results can be replicated across a broader patient population.
RAMAT GAN, Israel, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, announced today that a patient currently treated with Namodenoson in a compassionate use program in Can-Fite’s Phase II Liver Cancer Study has an overall survival time of 8 years with a complete response.
The patient, who suffered from advanced liver cancer was enrolled in the former Can-Fite Phase II study, continue to be treated with Namodenoson, and has now an overall survival of 8 years, with disappearance of ascites, normal liver function, good quality of life and is defined as a long term complete response.
Can-Fite is currently enrolling patients in Israel, Europe and the US for a pivotal Phase III clinical study for patients with advanced HCC as a 2nd or 3rd line treatment and Namodenoson is administered twice daily orally. The study protocol has been agreed upon with 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 a very favorable safety profile and anti-cancer effect of Namodenoson, we are now enrolling patients for the pivotal Phase III clinical study where we expect to prolong patients’ overall survival, and see a response similar to that of the patient who has now been treated with Namodenoson for 8 years. The uniqueness of Namodenoson which specifically acts against the tumor cells and protects the normal liver cells, is the rationale for the conductance of the current trial,” stated Prof. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel.
According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly 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 was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). 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.
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. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of MASH a Phase III 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: 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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