Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CF102 · 3 trials · 2 indications
Mean percent change in serum alanine aminotransferase (ALT) levels
Percent change from Baseline in hepatic steatosis measured by magnetic resonance imaging-determined proton-density fat-fraction (MRI-PDFF)
Evaluate the efficacy of orally administered CF102 25 mg twice daily (BID) as compared to placebo, as determined by Overall Survival (OS), when used as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B (CPB) cirrhosis. Overall Survival is defined as the time from Baseline (Cycle 1 Day 1) to death due to any cause, calculated as (date of death- date of Cycle 1 Day 1) +1.OS will be summarized in months, which will be obtained by dividing OS in days by 30 days/month. Summary statistics will be determined using the Kaplan-Meier (KM) estimate of the survival function and the between-treatment comparison will be performed using the logrank test as the primary analysis.
Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1
The MTD was defined as the highest dose level at which \< 2 of 6 patients developed Cycle 1 DLT.
Blood samples were collected and plasma concentrations determined using a high-pressure liquid chromatography method.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo tablets orally q12h |
| CF102 12.5mg | ACTIVE_COMPARATOR | CF102 tablets orally q12h |
| CF102 25mg | ACTIVE_COMPARATOR | CF102 tablets orally q12h |
| CF102 | EXPERIMENTAL | orally q12h |
| Placebo tablets of CF102 | PLACEBO_COMPARATOR | orally q12h |
| CF102 1mg | EXPERIMENTAL | An open-label trial in 28-day cycles. |
| CF102 5mg | EXPERIMENTAL | An open-label trial in 28-day cycles. |
| Name | Type | Description |
|---|---|---|
| CF102 | DRUG | orally q12h |
| Placebo | DRUG | orally q12h |
Inclusion Criteria: 1. At least 18 years of age. 2. Diagnosis of NAFLD by non-invasive determination of liver triglyceride concentration, as defined as triglyceride concentration ≥10.0% by NMRS. 3. At least 2 of the following: * Obesity, defined as body mass index (BMI) of ≥25 and ≤40 kg/m2; or...
CF 102 is an investigational small molecule being studied for chronic Hepatitis C, hepatocellular carcinoma (HCC), and non-alcoholic steatohepatitis (NASH). It is being developed by Can-Fite Biopharma Ltd (CANF) and is currently in Phase 1 clinical development for these indications.
CF 102 is a small molecule that targets the A3 adenosine receptor, which is involved in the regulation of cell growth and apoptosis. By activating this receptor, CF 102 may inhibit tumor cell proliferation and reduce inflammation, making it a potential treatment for liver diseases and cancers.
CF 102 is being developed by Can-Fite Biopharma Ltd, a biopharmaceutical company traded on the stock exchange under the ticker symbol CANF. The company is focused on developing small molecule drugs for inflammatory and oncological indications.
CF 102 is currently in Phase 1 clinical development. It has completed Phase 1 and Phase 2 trials for hepatocellular carcinoma, chronic Hepatitis C, and non-alcoholic steatohepatitis, but it is not yet approved by regulatory authorities and remains investigational.
CF 102 has completed several clinical trials, including NCT00790218 for advanced hepatocellular carcinoma, NCT00790673 for chronic Hepatitis C genotype 1, NCT02128958 for hepatocellular carcinoma, and NCT02927314 for non-alcoholic fatty liver disease. These trials have been completed, with no active trials currently ongoing.
CF 102 is also known as namodenoson, a selective A3 adenosine receptor agonist. It is being investigated for its potential to treat liver diseases and cancers, and it is distinct from other adenosine receptor agonists due to its high selectivity for the A3 subtype.