Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Cl-IB-MECA, IB-MECA, 2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide
CF 102 · 4 trials · 3 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 |
| 1 | EXPERIMENTAL | CF102 1 mg qd |
| 2 | EXPERIMENTAL | CF102 1 mg bid |
| 3 | EXPERIMENTAL | CF102 1 mg bid; 16 weeks |
| 5 | PLACEBO_COMPARATOR | - |
| 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 |
| CF 102 | DRUG | Oral capsules |
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 developed by Can-Fite Biopharma Ltd (ticker CANF). It has been studied in clinical trials for chronic hepatitis C, hepatocellular carcinoma, and non-alcoholic steatohepatitis (NASH). It is not an approved therapy and remains in clinical development.
CF 102 has been evaluated in clinical trials for three liver-related conditions: chronic hepatitis C, hepatocellular carcinoma, and non-alcoholic steatohepatitis (NASH). These studies were conducted in patients with those diagnoses. CF 102 is investigational and has not been approved for any indication.
CF 102 targets the A3 adenosine receptor, a G protein-coupled receptor. By binding this receptor, CF 102 acts on adenosine signaling pathways implicated in liver inflammation and cancer cell proliferation. This receptor is the molecular target studied across its hepatitis C, hepatocellular carcinoma, and NASH programs.
CF 102 is developed by Can-Fite Biopharma Ltd, an Israeli biopharmaceutical company whose shares trade under the ticker CANF. Can-Fite has sponsored the clinical trials evaluating CF 102 in chronic hepatitis C, hepatocellular carcinoma, and non-alcoholic steatohepatitis.
CF 102 is in Phase 1 development overall, though individual studies have reached Phase 2. It is investigational and has not received FDA approval. Trials completed to date include Phase 1/2 and Phase 2 studies in chronic hepatitis C, hepatocellular carcinoma, and NASH.
CF 102 has completed four registered trials: NCT02927314 in NASH, NCT02128958 in hepatocellular carcinoma, NCT00790673 in chronic hepatitis C genotype 1, and NCT00790218 in advanced hepatocellular carcinoma. All are completed, with no active trials currently recruiting. Total enrollment across these studies was 189 patients.
Yes, CF 102 and CF102 refer to the same investigational drug developed by Can-Fite Biopharma. The spacing differs only in formatting; both names identify the same A3 adenosine receptor targeting small molecule studied in liver disease trials.