Following FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite’s Namodenoson, Leading U.S. Medical Centers Seek Authorization for their Patients
Can-Fite BioPharma (NYSE American: CANF) reports growing interest from leading U.S. medical centers seeking FDA compassionate use approval for Namodenoson in pancreatic carcinoma treatment. This follows the FDA's recent approval of the first single-patient compassionate use treatment with the oncological drug.
The company is currently enrolling patients in Israel for a Phase IIa study, an open-label trial for advanced pancreatic adenocarcinoma patients whose disease has progressed despite first-line therapy. The study, led by Dr. Salomon Stemmer at Rabin Medical Center, aims to evaluate safety, clinical activity, and pharmacokinetics of Namodenoson.
Notably, Namodenoson has received Orphan Drug Designation from the U.S. FDA, highlighting its potential as a treatment option for this underserved patient population.
Can-Fite BioPharma (NYSE American: CANF) segnala un crescente interesse da parte dei principali centri medici statunitensi che richiedono l'approvazione della FDA per l'uso compassionevole di Namodenoson nel trattamento del carcinoma pancreatico. Ciò arriva dopo l'approvazione recente da parte della FDA del primo trattamento compassionevole per singolo paziente con questo farmaco oncologico.
Attualmente, l'azienda sta arruolando pazienti in Israele per uno studio di Fase IIa, uno studio open-label su pazienti con adenocarcinoma pancreatico avanzato la cui malattia è progredita nonostante la terapia di prima linea. Lo studio, guidato dal dott. Salomon Stemmer presso il Rabin Medical Center, ha l'obiettivo di valutare la sicurezza, l'attività clinica e la farmacocinetica di Namodenoson.
È importante sottolineare che Namodenoson ha ricevuto la Designazione di Farmaco Orfano dalla FDA statunitense, evidenziando il suo potenziale come opzione terapeutica per questa popolazione di pazienti poco servita.
Can-Fite BioPharma (NYSE American: CANF) informa sobre un creciente interés por parte de los principales centros médicos de EE. UU. que buscan la aprobación de uso compasivo de la FDA para Namodenoson en el tratamiento del carcinoma pancreático. Esto sigue a la reciente aprobación por parte de la FDA del primer tratamiento de uso compasivo para un solo paciente con este medicamento oncológico.
La compañía está actualmente reclutando pacientes en Israel para un estudio de Fase IIa, un ensayo abierto para pacientes con adenocarcinoma pancreático avanzado cuya enfermedad ha progresado a pesar de la terapia de primera línea. El estudio, dirigido por el Dr. Salomon Stemmer en el Rabin Medical Center, tiene como objetivo evaluar la seguridad, la actividad clínica y la farmacocinética de Namodenoson.
Es importante destacar que Namodenoson ha recibido la Designación de Medicamento Huérfano por parte de la FDA de EE. UU., lo que resalta su potencial como opción de tratamiento para esta población de pacientes desatendida.
Can-Fite BioPharma (NYSE American: CANF)는 미국 주요 의료기관들이 췌장암 치료를 위한 Namodenoson의 FDA 동정적 사용 승인을 요청하는 관심이 증가하고 있다고 보고합니다. 이는 FDA가 최근 이 항암제에 대해 단일 환자 동정적 사용 치료를 처음으로 승인한 데 따른 것입니다.
현재 회사는 이스라엘에서 2a상 연구를 위해 환자를 모집 중이며, 이는 1차 치료에도 불구하고 병이 진행된 진행성 췌장 선암 환자를 대상으로 한 공개 라벨 시험입니다. 라빈 의료센터의 Dr. Salomon Stemmer가 이끄는 이 연구는 Namodenoson의 안전성, 임상 효과 및 약동학을 평가하는 것을 목표로 합니다.
특히 Namodenoson은 미국 FDA로부터 희귀의약품 지정을 받아, 이 소외된 환자군에 대한 치료 옵션으로서의 가능성을 강조하고 있습니다.
Can-Fite BioPharma (NYSE American : CANF) rapporte un intérêt croissant de la part des principaux centres médicaux américains qui sollicitent l'approbation de la FDA pour un usage compassionnel de Namodenoson dans le traitement du carcinome pancréatique. Cela fait suite à l'approbation récente par la FDA du premier traitement compassionnel pour un patient unique avec ce médicament oncologique.
L'entreprise recrute actuellement des patients en Israël pour une étude de Phase IIa, un essai ouvert chez des patients atteints d'adénocarcinome pancréatique avancé dont la maladie a progressé malgré un traitement de première ligne. L'étude, dirigée par le Dr Salomon Stemmer au Rabin Medical Center, vise à évaluer la sécurité, l'activité clinique et la pharmacocinétique de Namodenoson.
Il est à noter que Namodenoson a reçu la Désignation de Médicament Orphelin de la FDA américaine, soulignant son potentiel en tant qu'option thérapeutique pour cette population de patients peu prise en charge.
Can-Fite BioPharma (NYSE American: CANF) berichtet von wachsendem Interesse führender US-amerikanischer medizinischer Zentren, die eine FDA-Genehmigung für die einfühlsame Anwendung von Namodenoson bei der Behandlung von Bauchspeicheldrüsenkarzinomen anstreben. Dies folgt auf die kürzliche FDA-Zulassung der ersten Einzelfall-Anwendung des onkologischen Medikaments.
Das Unternehmen rekrutiert derzeit Patienten in Israel für eine Phase-IIa-Studie, eine offene Studie bei Patienten mit fortgeschrittenem Pankreasadenokarzinom, deren Erkrankung trotz Erstlinientherapie fortgeschritten ist. Die Studie unter der Leitung von Dr. Salomon Stemmer am Rabin Medical Center zielt darauf ab, die Sicherheit, klinische Wirksamkeit und Pharmakokinetik von Namodenoson zu bewerten.
Besonders hervorzuheben ist, dass Namodenoson von der US-FDA die Orphan-Drug-Designation erhalten hat, was sein Potenzial als Behandlungsoption für diese unterversorgte Patientengruppe unterstreicht.
- FDA approval received for first single-patient compassionate use treatment
- Growing interest from leading U.S. medical centers for compassionate use program
- Active Phase IIa trial enrollment ongoing
- FDA Orphan Drug Designation obtained
- Drug still in early clinical development phase
- to compassionate use approval only, not full FDA approval
Insights
FDA compassionate use approval for Namodenoson in pancreatic cancer shows clinical interest, but remains very early-stage with uncertain efficacy.
The FDA's compassionate use authorization for Can-Fite's Namodenoson in pancreatic carcinoma represents an important clinical milestone, particularly as additional leading U.S. medical centers are now pursuing similar authorizations. This growing physician interest signals potential clinical recognition of Namodenoson's mechanism of action.
Pancreatic adenocarcinoma remains one of oncology's most challenging malignancies, with dismal survival rates and effective treatment options after first-line therapy failure. The Orphan Drug Designation granted by the FDA acknowledges this unmet medical need and provides regulatory incentives that could accelerate development.
The ongoing Phase IIa study in Israel represents the critical next step. This open-label trial will assess safety, clinical activity, and pharmacokinetics in advanced pancreatic cancer patients who have progressed despite first-line therapy. Dr. Stemmer's involvement as a recognized key opinion leader lends credibility to the trial design.
However, I must emphasize that compassionate use authorization, while promising, remains distinct from clinical trial validation. Efficacy and safety data from the Phase IIa study will be essential for determining Namodenoson's true therapeutic potential in pancreatic cancer.
Growing physician interest in Namodenoson for compassionate use offers early validation for Can-Fite, but commercial potential remains speculative at this phase.
For Can-Fite, a microcap biotech with approximately
The Orphan Drug Designation is particularly valuable for a company of Can-Fite's size, offering potential benefits including tax credits for clinical trials, waived FDA fees, and critically, seven years of market exclusivity upon approval. These incentives substantially improve the commercial outlook for Namodenoson if efficacy is demonstrated.
However, investors should recognize that Phase IIa represents an early clinical development stage with significant remaining hurdles. Many oncology drugs that show initial promise fail in larger, later-phase trials. The pancreatic cancer therapeutic landscape is littered with prior development failures.
While this news creates positive momentum for Can-Fite, the true value inflection points will come with clinical data readouts from the Phase IIa study. Increased physician interest suggests potential market acceptance if the drug eventually reaches approval, but commercial success remains highly speculative at this juncture.
Ramat Gan, Israel, April 17, 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 leading Medical Centers in the US are approaching the FDA, asking for compassionate use approval to treat patients with pancreatic carcinoma with the company oncological drug Namodenoson.
Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols.
Simultaneously, Can-Fite is actively enrolling patients in Israel for a Phase IIa study—an open-label trial designed for individuals with advanced pancreatic adenocarcinoma whose disease has progressed despite at least first-line therapy. The trial aims to assess the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this challenging patient population. The study is led by Dr. Salomon Stemmer, a renowned key opinion leader at the Institute of Oncology, Rabin Medical Center, Israel. Notably, Namodenoson has been granted Orphan Drug Designation by the U.S. FDA, further underscoring its potential as a promising therapeutic option.
“We are thrilled that more top-tier U.S. medical centers are recognizing the potential of Namodenoson and are eager to participate in our compassionate use program,” said Motti Farbstein, CEO of Can-Fite. “Our goal is to provide this underserved patient population with a novel treatment that may extend survival and improve quality of life.”
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
+972-3-9241114
FAQ
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