Can-Fite Achieves Milestone with First Patient Dosing in Pancreatic Cancer Phase IIa Clinical Trial
Can-Fite BioPharma (NYSE American: CANF) has announced the first patient dosing in its Phase IIa clinical trial for advanced pancreatic adenocarcinoma. The multicenter open-label trial will evaluate Namodenoson, administered orally at 25 mg twice daily, in approximately 20 evaluable patients whose disease has progressed on at least first-line therapy. The study's primary objective is to assess safety, while secondary objectives include evaluating clinical activity through metrics like Objective Response Rate, Progression-Free Survival, and Overall Survival. The trial is being conducted at Rabin Medical Center, Israel, and UT Southwestern Medical Center, US. Notably, Namodenoson has recently received Orphan Drug Designation from the US FDA.
Can-Fite BioPharma (NYSE American: CANF) ha annunciato il primo trattamento del paziente nel suo studio clinico di fase IIa per l'adenocarcinoma pancreatico avanzato. Lo studio multicentrico in aperto valuterà Namodenoson, somministrato per via orale a 25 mg due volte al giorno, in circa 20 pazienti valutabili la cui malattia è progredita dopo almeno una terapia di prima linea. L'obiettivo principale dello studio è valutare la sicurezza, mentre gli obiettivi secondari includono la valutazione dell'attività clinica attraverso metriche come il Tasso di Risposta Obiettivo, il Tempo di Sopravvivenza Libero da Progressione e la Sopravvivenza Complessiva. La sperimentazione si sta svolgendo presso il Rabin Medical Center in Israele e il UT Southwestern Medical Center negli Stati Uniti. È importante notare che Namodenoson ha recentemente ricevuto la designazione di farmaco orfano dalla FDA statunitense.
Can-Fite BioPharma (NYSE American: CANF) ha anunciado la primera dosificación del paciente en su ensayo clínico de fase IIa para el adenocarcinoma pancreático avanzado. El ensayo multicéntrico, abierto y sin enmascaramiento evaluará Namodenoson, administrado por vía oral a 25 mg dos veces al día, en aproximadamente 20 pacientes evaluables cuya enfermedad ha progresado en al menos terapia de primera línea. El objetivo principal del estudio es evaluar la seguridad, mientras que los objetivos secundarios incluyen la evaluación de la actividad clínica a través de métricas como la Tasa de Respuesta Objetiva, la Supervivencia Libre de Progresión y la Supervivencia General. El ensayo se está llevando a cabo en el Centro Médico Rabin en Israel y en el Centro Médico UT Southwestern en EE. UU. Cabe destacar que Namodenoson ha recibido recientemente la designación de medicamento huérfano por parte de la FDA de EE. UU.
Can-Fite BioPharma (NYSE American: CANF)는 진행성 췌장 선암에 대한 2단계 임상 시험에서 첫 번째 환자 투여를 발표했습니다. 다기관 오픈 라벨 시험은 Namodenoson을 하루 두 번 25mg 경구 투여하여 약 20명의 평가 가능한 환자를 대상으로 질병이 최소한 1차 치료에서 진행된 경우에 대해 평가합니다. 연구의 주요 목표는 안전성을 평가하는 것이며, 2차 목표로는 객관적 반응률, 무진행 생존 기간, 전체 생존율과 같은 지표를 통한 임상적 활성을 평가하는 것을 포함합니다. 이 시험은 이스라엘의 라빈 메디컬 센터와 미국의 UT Southwestern 메디컬 센터에서 수행되고 있습니다. 특히, Namodenoson은 최근 미국 FDA로부터 희귀약품 지정을 받았습니다.
Can-Fite BioPharma (NYSE American: CANF) a annoncé le premier traitement du patient dans son essai clinique de phase IIa pour l'adénocarcinome pancréatique avancé. L'essai multicentrique en ouvert évaluera Namodenoson, administré par voie orale à 25 mg deux fois par jour, chez environ 20 patients évaluables dont la maladie a progressé après au moins une thérapie de première ligne. L'objectif principal de l'étude est d'évaluer la sécurité, tandis que les objectifs secondaires incluent l'évaluation de l'activité clinique à travers des indicateurs tels que le Taux de Réponse Objectif, la Survie Sans Progression, et la Survie Globale. L'essai est réalisé au Rabin Medical Center en Israël et au UT Southwestern Medical Center aux États-Unis. Notamment, Namodenoson a récemment reçu la désignation de médicament orphelin de la part de la FDA américaine.
Can-Fite BioPharma (NYSE American: CANF) hat die erste Patientenbehandlung in seiner Phase IIa-Studie für fortgeschrittenes Pankreasadenokarzinom bekannt gegeben. Die multizentrische, offen durchgeführte Studie wird Namodenoson bewerten, das oral in einer Dosis von 25 mg zweimal täglich verabreicht wird, bei etwa 20 evaluierbaren Patienten, deren Erkrankung nach mindestens einer Erstlinienbehandlung fortgeschritten ist. Das Hauptziel der Studie besteht darin, die Sicherheit zu bewerten, während die sekundären Ziele die Bewertung der klinischen Aktivität durch Kennzahlen wie die objektive Ansprechrate, das progressionsfreie Überleben und das Gesamtüberleben umfassen. Die Studie wird im Rabin Medical Center in Israel und im UT Southwestern Medical Center in den USA durchgeführt. Erwähnenswert ist, dass Namodenoson kürzlich von der US FDA die Orphan Drug Designation erhalten hat.
- Received FDA Orphan Drug Designation for Namodenoson
- Successfully initiated Phase IIa clinical trial with first patient dosing
- None.
Insights
The initiation of Phase IIa clinical trial for Namodenoson in advanced pancreatic cancer represents a significant milestone, particularly given the recent FDA Orphan Drug Designation. The trial design is robust, targeting a critical unmet need in pancreatic cancer treatment with 20 evaluable patients receiving 25 mg twice daily. The study's comprehensive endpoints - including ORR, PFS, DCR, DoR and OS - will provide valuable efficacy data.
The involvement of prominent research centers and key opinion leaders adds credibility to the trial. The focus on patients who have progressed after first-line therapy is strategically important, as this population has treatment options. The Orphan Drug Designation provides potential benefits including tax credits for clinical trials, exemption from user fees and potential 7-year market exclusivity upon approval.
Orphan Drug Designation has been granted lately by US FDA
RAMAT GAN, Israel, Nov. 11, 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, today announces the dosing of the first patient in the Phase IIa clinical trial in patients with advanced pancreatic adenocarcinoma (NCT06387342).
“We are excited to have the first patient enrolled and hope that we will be able to demonstrate the safety and efficacy of Namodenoson in the pancreatic cancer patient population. This trial provides us the opportunity to explore our innovative treatment approach for patients who are facing significant gaps in effective treatment options,” stated Dr. Michael Silverman, Can-Fite’s Medical Officer.
The Phase IIa study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first-line therapy. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. All patients receive oral Namodenoson 25 mg, administered twice daily for consecutive 28-day cycles. Patients are being evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).
The study is being conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel and by Dr. Al Mutar from the UT Southwestern Medical Center in the US. Orphan Drug Designation has been granted lately by US FDA.
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
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Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
FAQ
What is the Phase IIa trial design for Can-Fite's (CANF) pancreatic cancer study?
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