Pancreatic Cancer Phase 2a Study with Can-Fite鈥檚 Namodenoson Achieved Over 50% Enrollment Milestone
Can-Fite BioPharma (NYSE American: CANF) announced achieving over 50% enrollment in its Phase 2a trial of Namodenoson for pancreatic cancer. The multicenter, open-label study evaluates the drug's safety, clinical activity, and pharmacokinetics in patients with advanced pancreatic adenocarcinoma who progressed after prior therapy.
Patients receive 25 mg of oral Namodenoson twice daily in 28-day cycles. The drug, which has received FDA Orphan Drug Designation for pancreatic cancer treatment, continues to demonstrate a favorable safety profile. The study is being conducted under the leadership of Prof. Salomon Stemmer at the Davidoff Center, Rabin Medical Center, Israel.
Can-Fite BioPharma (NYSE American: CANF) ha annunciato di aver superato il 50% di arruolamento nel suo studio di Fase 2a su Namodenoson per il cancro al pancreas. Lo studio multicentrico, in aperto, valuta la sicurezza, l'attivit脿 clinica e la farmacocinetica del farmaco in pazienti con adenocarcinoma pancreatico avanzato che hanno avuto progressione dopo terapie precedenti.
I pazienti ricevono 25 mg di Namodenoson per via orale due volte al giorno in cicli di 28 giorni. Il farmaco, che ha ottenuto la Designazione di Farmaco Orfano dalla FDA per il trattamento del cancro al pancreas, continua a mostrare un profilo di sicurezza favorevole. Lo studio 猫 condotto sotto la guida del Prof. Salomon Stemmer presso il Davidoff Center, Rabin Medical Center, Israele.
Can-Fite BioPharma (NYSE American: CANF) anunci贸 haber alcanzado m谩s del 50% de inscripci贸n en su ensayo de Fase 2a con Namodenoson para c谩ncer de p谩ncreas. El estudio multic茅ntrico, abierto, eval煤a la seguridad, actividad cl铆nica y farmacocin茅tica del medicamento en pacientes con adenocarcinoma pancre谩tico avanzado que progresaron tras terapias previas.
Los pacientes reciben 25 mg de Namodenoson oral dos veces al d铆a en ciclos de 28 d铆as. El medicamento, que ha recibido la Designaci贸n de Medicamento Hu茅rfano por la FDA para el tratamiento del c谩ncer de p谩ncreas, contin煤a mostrando un perfil de seguridad favorable. El estudio se realiza bajo la direcci贸n del Prof. Salomon Stemmer en el Davidoff Center, Rabin Medical Center, Israel.
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頇橃瀽霌れ潃 28鞚� 欤缄赴鞚� 靷澊韥� 霃欖晥 頃橂（ 霊� 氩� 25mg 瓴疥惮 Namodenoson鞚� 韴棳氚涭姷雼堧嫟. 旆岇灔鞎� 旃橂毳� 鞙勴暣 FDA 頋穩鞚橃暯頀� 歆�鞝�鞚� 氚涭潃 鞚� 鞎诫鞚� 瓿勳啀頃挫劀 鞖办垬頃� 鞎堨爠靹� 頂勲韺岇澕鞚� 氤挫棳欤缄碃 鞛堨姷雼堧嫟. 鞐瓣惮電� 鞚挫姢霛检棙 霛茧箞 鞚橂靹柬劙 雼る箘霃勴攧 靹柬劙鞚� Salomon Stemmer 甑愳垬鞚� 歆�霃� 頃橃棎 歆勴枆霅橁碃 鞛堨姷雼堧嫟.
Can-Fite BioPharma (NYSE American : CANF) a annonc茅 avoir atteint plus de 50 % d'inclusion dans son essai de phase 2a de Namod茅noson pour le cancer du pancr茅as. Cette 茅tude multicentrique en ouvert 茅value la s茅curit茅, l'activit茅 clinique et la pharmacocin茅tique du m茅dicament chez des patients atteints d'ad茅nocarcinome pancr茅atique avanc茅 ayant progress茅 apr猫s un traitement ant茅rieur.
Les patients re莽oivent 25 mg de Namod茅noson par voie orale deux fois par jour en cycles de 28 jours. Le m茅dicament, qui a re莽u la d茅signation de m茅dicament orphelin par la FDA pour le traitement du cancer du pancr茅as, continue de d茅montrer un profil de s茅curit茅 favorable. L'茅tude est conduite sous la direction du Professeur Salomon Stemmer au Davidoff Center, Rabin Medical Center, Isra毛l.
Can-Fite BioPharma (NYSE American: CANF) gab bekannt, dass in seiner Phase-2a-Studie mit Namodenoson bei Bauchspeicheldr眉senkrebs 眉ber 50% der Patienten eingeschlossen wurden. Die multizentrische, offene Studie bewertet die Sicherheit, klinische Wirksamkeit und Pharmakokinetik des Medikaments bei Patienten mit fortgeschrittenem Pankreasadenokarzinom, die nach vorheriger Therapie fortgeschritten sind.
Die Patienten erhalten 25 mg oral Namodenoson zweimal t盲glich in 28-Tage-Zyklen. Das Medikament, das die FDA-Orphan-Drug-Designation f眉r die Behandlung von Bauchspeicheldr眉senkrebs erhalten hat, zeigt weiterhin ein g眉nstiges Sicherheitsprofil. Die Studie wird unter der Leitung von Prof. Salomon Stemmer im Davidoff Center des Rabin Medical Center in Israel durchgef眉hrt.
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Insights
Can-Fite's 50% enrollment milestone in pancreatic cancer trial shows promising safety profile for Namodenoson with potential FDA advantages via Orphan designation.
Can-Fite BioPharma (CANF) has reached a significant clinical development milestone with over 50% enrollment in their Phase 2a trial evaluating Namodenoson for advanced pancreatic adenocarcinoma. The trial focuses primarily on safety, with secondary endpoints examining clinical activity and pharmacokinetics.
The current trial design is particularly noteworthy. Patients receive 25mg of oral Namodenoson twice daily in continuous 28-day cycles, with eligibility requiring disease progression after at least one prior treatment line. This positions Namodenoson as a potential second-line or later therapy in a disease with extremely limited treatment options.
Pancreatic cancer represents one of oncology's most significant unmet needs, with dismal survival rates and few effective treatments. The FDA's Orphan Drug Designation for Namodenoson in pancreatic cancer provides several strategic advantages, including market exclusivity, regulatory support, and potential tax credits - critical incentives for developing therapies in this challenging space.
Mechanistically, Namodenoson functions as a selective A3 adenosine receptor (A3AR) agonist. This approach differs from many conventional cytotoxic therapies, potentially offering a novel mechanism of action with a more favorable safety profile. The preliminary safety observations from this trial align with expectations based on the drug's mechanism and prior clinical experience.
The engagement of Prof. Salomon Stemmer, a recognized oncology key opinion leader, adds credibility to the trial. The reported favorable safety profile to date represents an important positive signal, as tolerability often limits treatment options in advanced pancreatic cancer patients.
Primary endpoint is safety; Namodenoson continues to demonstrate a favorable safety profile
Ramat Gan, Israel, July 30, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced that it achieved the over
The Phase 2a study is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.
鈥淭his milestone reflects the strong interest among both investigators and patients in exploring Namodenoson as a potential treatment for one of the deadliest and most aggressive cancers,鈥� stated Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma. 鈥淲e are encouraged by the pace of enrollment and remain committed to advancing Namodenoson as a much-needed therapeutic option for patients with pancreatic cancer.鈥�
Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.
Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
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鈥檚 lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite鈥檚 liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a 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鈥檚 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: .
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FAQ
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