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Noticias de CANF
Eventos de CANF
Can-Fite BioPharma Evaluates Interim Analysis Timing for Namodenoson Study
Can-Fite BioPharma announced that blinded overall survival observed across the entire patient population in its ongoing pivotal Phase III study of Namodenoson in advanced hepatocellular carcinoma, or HCC, appears longer than originally anticipated based on the assumptions underlying the study design. The pivotal Phase III study is a randomized, double-blind, placebo-controlled study evaluating Namodenoson in patients with advanced HCC and underlying Child-Pugh B7 cirrhosis. Patients are randomized 2:1 to receive Namodenoson or placebo, with overall survival as the primary efficacy endpoint. The observed survival reflects the pooled, blinded study population and includes patients receiving both Namodenoson and placebo. Accordingly, no conclusions regarding treatment efficacy or differences between the study arms can be drawn from these data at this stage. In view of the longer-than-anticipated survival observed in the study population, Can-Fite is evaluating an earlier timing for the study's planned interim analysis. The interim analysis will enable an independent assessment of overall survival between the Namodenoson and placebo treatment groups in accordance with the study's statistical analysis plan and applicable regulatory requirements.
Can-Fite BioPharma Files $100M Mixed Securities Shelf
Can-Fite BioPharma files $100M mixed securities shelf
Can-Fite BioPharma Submits Piclidenoson Clinical Study Protocol
Can-Fite BioPharma announced the submission of a Phase 2 clinical study protocol to Bambino Gesu Children's Hospital in Rome, Italy, for the first clinical evaluation of Piclidenoson in patients with Lowe syndrome, a rare inherited genetic disorder with no approved disease-modifying therapies. The study will be led by Francesco Emma, an internationally recognized expert in inherited kidney diseases.
Can-Fite Secures Australian Patent for Advanced Cancer Treatment
Can-Fite BioPharma announced that the Australian Patent Office has allowed Patent Application No. 2021290439 entitled "Treatment of Advanced Metastatic Cancer." The patent complements Can-Fite's oncology pipeline. Namodenoson is currently being evaluated in a pivotal Phase 3 study for advanced hepatocellular carcinoma following FDA and EMA protocol agreement. In pancreatic cancer, the company recently completed a Phase 2a clinical study demonstrating an excellent safety profile together with encouraging survival outcomes and durable disease stabilization and is planning a Phase 2b study evaluating Namodenoson in combination with gemcitabine.
Can-Fite BioPharma Completes Enrollment of 247 Patients
Can-Fite BioPharma announced completion of enrolment of the first 247 patients in its Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis. The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the FDA and the European Medicines Agency. The interim analysis will evaluate efficacy and safety data from the enrolled patients. Results are expected during Q4 2026/Q1 2027.
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