Can-Fite: FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient
Can-Fite BioPharma (NYSE American: CANF) announced FDA approval for compassionate use of its anti-cancer drug Namodenoson in a U.S. pancreatic cancer patient. Compassionate use allows physician-requested access to unapproved investigational drugs for serious diseases.
Namodenoson is currently undergoing multiple clinical trials, including LiverationTM, a pivotal Phase III study for advanced liver cancer approved by both FDA and EMA, and a Phase IIa pancreatic cancer study in Israel. The drug has received Orphan Drug Designation from the FDA for pancreatic cancer, potentially providing seven years of market exclusivity post-approval along with regulatory advantages.
Can-Fite BioPharma (NYSE American: CANF) ha annunciato l'approvazione da parte della FDA per l'uso compassionevole del suo farmaco antitumorale Namodenoson in un paziente statunitense affetto da cancro al pancreas. L'uso compassionevole consente l'accesso a farmaci sperimentali non approvati su richiesta del medico per malattie gravi.
Namodenoson è attualmente oggetto di molteplici studi clinici, tra cui LiverationTM, uno studio pivotale di Fase III per il cancro avanzato al fegato approvato sia dalla FDA che dall'EMA, e uno studio di Fase IIa sul cancro al pancreas in Israele. Il farmaco ha ricevuto la Designazione di Farmaco Orfano dalla FDA per il cancro al pancreas, offrendo potenzialmente sette anni di esclusiva di mercato dopo l'approvazione, insieme a vantaggi normativi.
Can-Fite BioPharma (NYSE American: CANF) anunció la aprobación de la FDA para el uso compasivo de su medicamento anticancerígeno Namodenoson en un paciente estadounidense con cáncer de páncreas. El uso compasivo permite el acceso a medicamentos en investigación no aprobados a solicitud del médico para enfermedades graves.
Namodenoson está actualmente en múltiples ensayos clínicos, incluyendo LiverationTM, un estudio pivotal de Fase III para cáncer de hígado avanzado aprobado tanto por la FDA como por la EMA, y un estudio de Fase IIa para cáncer de páncreas en Israel. El medicamento ha recibido la Designación de Medicamento Huérfano de la FDA para cáncer de páncreas, lo que potencialmente proporciona siete años de exclusividad en el mercado tras la aprobación, junto con ventajas regulatorias.
Can-Fite BioPharma (NYSE American: CANF)는 미국 췌장암 환자에 대한 항암제 Namodenoson의 동정적 사용에 대한 FDA 승인을 발표했습니다. 동정적 사용은 심각한 질병에 대한 승인되지 않은 연구 약물에 대한 의사 요청 접근을 허용합니다.
Namodenoson은 현재 여러 임상 시험을 진행 중이며, 여기에는 FDA와 EMA 모두에서 승인된 진행성 간암을 위한 주요 3상 연구인 LiverationTM와 이스라엘의 췌장암 2a상 연구가 포함됩니다. 이 약물은 췌장암에 대해 FDA로부터 희귀의약품 지정을 받아, 승인 후 7년의 시장 독점권과 규제상의 이점을 제공할 수 있습니다.
Can-Fite BioPharma (NYSE American: CANF) a annoncé l'approbation par la FDA de l'utilisation compassionnelle de son médicament anticancéreux Namodenoson chez un patient américain atteint d'un cancer du pancréas. L'utilisation compassionnelle permet l'accès à des médicaments expérimentaux non approuvés sur demande du médecin pour des maladies graves.
Namodenoson est actuellement en cours de plusieurs essais cliniques, y compris LiverationTM, une étude pivot de Phase III pour le cancer du foie avancé approuvée par la FDA et l'EMA, ainsi qu'une étude de Phase IIa sur le cancer du pancréas en Israël. Le médicament a reçu la Designation de Médicament Orphelin de la FDA pour le cancer du pancréas, ce qui pourrait offrir sept ans d'exclusivité sur le marché après approbation, ainsi que des avantages réglementaires.
Can-Fite BioPharma (NYSE American: CANF) hat die Genehmigung der FDA für den mitfühlenden Einsatz seines Krebsmedikaments Namodenoson bei einem US-Patienten mit Bauchspeicheldrüsenkrebs bekannt gegeben. Der mitfühlende Einsatz erlaubt den Zugang zu nicht genehmigten experimentellen Medikamenten auf ärztliche Anfrage für schwere Krankheiten.
Namodenoson befindet sich derzeit in mehreren klinischen Studien, darunter LiverationTM, eine entscheidende Phase-III-Studie für fortgeschrittenen Leberkrebs, die sowohl von der FDA als auch von der EMA genehmigt wurde, sowie eine Phase-IIa-Studie zu Bauchspeicheldrüsenkrebs in Israel. Das Medikament hat von der FDA die Orphan Drug Designation für Bauchspeicheldrüsenkrebs erhalten, was potenziell sieben Jahre Marktexklusivität nach der Genehmigung sowie regulatorische Vorteile bietet.
- FDA granted compassionate use approval for Namodenoson in pancreatic cancer
- Ongoing Phase III trial for liver cancer approved by both FDA and EMA
- FDA Orphan Drug Designation secured for pancreatic cancer treatment
- Potential 7-year market exclusivity post-approval
- Compassionate use approval to single patient only
- Drug still in clinical trial phase, not yet FDA approved
- Phase IIa pancreatic cancer trial to Israel only
Ramat Gan, Israel, March 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 that it received a single FDA approval for the compassionate use treatment of a U.S. based pancreatic cancer patient with its anti-cancer drug Namodenoson.
Compassionate use is the term used when a physician is requesting for a single patient to gain access to an investigational drug for a serious disease. Such investigational drug has not yet been approved by the FDA.
Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase 2a clinical trial, as we remain committed to advancing the availability of our drug."
Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the FDA and the European Medicines Agency (EMA). The drug is currently being tested in Israel in a Phase IIa pancreatic cancer clinical study.
Namodenoson, has been also granted Orphan Drug Designation by the FDA for pancreatic cancer. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven years after approval and several and regulatory advantages.
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
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Contact
Can-Fite BioPharma
Motti Farbstein
+972-3-9241114
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