Date: 2014-12-22
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Can-Fite BioPharma (Israel)
Product: CF102 (Cl-IB-MECA - 2-chloro-N6-(3-iodobenzyl)-adenosine-5’- N-methyl-uronamide)
Action
mechanism: adenosine A3 receptor agonist. CF102 is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5’- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR). CF102 mechanism of action is mediated via de-regulation of the NF-κB and the Wnt signal transduction pathways, resulting in apoptosis of tumor cells. The protective effect of CF102 is mediated via down-regulation of the NF-κB signal transduction pathway and preventing apoptosis.
Disease: hepatocellular carcinoma
Therapeutic area: Cancer - Oncology - Rare diseases
Country:
Trial details:
Latest
news: * On December 22, 2014, Can-Fite BioPharma, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, announced that it has dosed the first patient in a Phase II trial for the treatment of hepatocellular carcinoma (HCC). The Phase II randomized, double-blind, placebo controlled trial is to be conducted in the U.S., Europe and Israel with an estimated 78 patients to be enrolled. CF 102 is being evaluated for efficacy and safety as a second-line treatment for advanced HCC in subjects with Child-Pugh B who failed Nexavar® as a first line treatment. The first patient was dosed at the study\'s Israeli site, the Rabin Medical Center. The primary endpoint of the study is overall patient survival. This Phase II study follows favorable results in Can-Fite\'s Phase I/II study, which was an open-label, dose-escalation study that evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the orally administered CF102 in patients with advanced primary HCC. Data from that trial showed prolonged survival, stable disease in some patients, and regression of skin tumor metastases, as well as a favorable safety profile and lack of hepatotoxicity.
