GoldenBiotech’s Antroquinonol Completed Phase 1 Trial and Started Phase 2 for Metastatic Pancreatic Cancer as First Line Treatment
GoldenBiotech(TW4132), a Taiwan based global pharmaceutical company just announced its Antroquinonol (Hocena) Phase 1/2 clinical trial for Stage 4 metastatic Pancreatic Cancer has completed the phase 1 safety trial combined treatment with standard chemotherapeutic drugs including higher doses treatment. The results of the trial were very satisfactory, and the subjects responded well.
Confirmed and agreed by all participating PI Meeting clinicians for its safety results and therapeutic effects ,the recommended dosage were confirmed as well.
According to the protocol approved by the US FDA, it entered to the Phase 2 trial in the United States, Taiwan and South Korea to conduct an efficacy test of 40 people.
Antroquinonol(Hocena) has been granted Orphan Drug Designation(ODD) as a treatment drug for pancreatic cancer by US FDA in 2015 and European EMA in 2017.
Antroquinonol is proposed for the treatment of neoplasms. The proposed clinical trial is a Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic carcinoma.
The first part of study will focus on the treatment of pancreatic cancer with 200 mg TID and 300 mg TID, clinical treatment duration of 4 weeks, to determine the MTD or MFD (based on PK and capsules strength) of antroquinonol in combination with a standard dose regimen of nab-paclitaxel and gemcitabine.
The extended Phase II will focus on the efficacy of antroquinonol with SOC. Safety and pharmacokinetic profiles will be studied in the proposed clinical trial.