Clinical stage, biopharmaceutical company Tracon Pharmaceuticals (TCON) has started dosing patients in a Phase lb/ll clinical trial to evaluate TRC105 in combination with nexavar (sorafenib), a vascular endothelial growth factor (VEGF) inhibitor, to treat hepatocellular carcinoma (HCC).
TRC105 is a new, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is necessary for angiogenesis, the process of new blood vessel formation.
Currently, the drug is being studied in multiple Phase ll clinical trials sponsored by TRACON or the National Cancer Institute, US to treat solid tumour types in combination with VEGF inhibitors.
The Phase lb/ll trial is an open-label, non-randomised clinical trial of TRC105 in combination with nexavar in patients with HCC who have not received prior systemic therapy.
During the trial, TRC105 will be dosed every other week in combination with standard dose nexavar, 800mg per day.
Around 39 patients are expected to enrol at multiple centres in the US and the clinical data is expected next year.
Last year, the National Cancer Institute has reported data from its Phase l/ll trial evaluating the combination of TRC105 and nexavar in HCC patients.
Four out of ten patients with measurable disease treated at the recommended Phase ll doses of TRC105 achieved partial responses by RECIST, a standardised radiographic response criteria.
In comparison, the partial response rate of single agent nexavar was 2% and 3% by RECIST in separate Phase lll trials, while the combination of TRC105 and nexavar was found to be well-tolerated in the NCI trial.
Tracon Pharmaceuticals president and CEO Dr Charles Theuer said: "Hepatocellular carcinoma, the second leading cause of cancer deaths worldwide, is a vascular tumour with limited treatment options.
"The combination of TRC105 and nexavar demonstrated a 40% response rate at recommended TRC105 Phase ll doses in a National Cancer Institute-sponsored trial.
"In order to further explore the safety and efficacy of the combination, Tracon has initiated a multi-centre clinical trial in this widespread indication."