Golden Biotechnology Corporation announces the release of positive interim results from its Phase II clinical trial of Antroquinonol (HOCENA®) in combination with the standard of care (SOC) nab-paclitaxel + gemcitabine for first-line treatment of metastatic pancreatic cancer. The median overall survival (mOS) was 12.6 months, which was 48% better than the 8.5 months mOS in the Phase III clinical study of the standard of care (nab-paclitaxel + gemcitabine). Compared to the current first-line treatments for this difficult to treat cancer, this study demonstrated that Antroquinonol in combination with SOC showed a significant survival advantage.

The Phase II Antroquinonol clinical trial is a single-arm Phase I/II study to evaluate the safety and efficacy of Antroquinonol in combination with SOC (nab-paclitaxel + gemcitabine) as a first-line treatment for stage IV metastatic pancreatic cancer. The first stage of the study focused on treating pancreatic cancer with oral Antroquinonol at doses of 200 mg three times daily and 300 mg three times daily for a duration of 4 weeks; to determine the maximum tolerated dose regimen for Antroquinonol in combination with SOC. The expanded Phase II trial will focus on the efficacy of Antroquinonol in combination with SOC.

This is a multi-national and multi-center clinical trial enrolling patients in the United States, Taiwan and South Korea. Compared to the results of the Phase III study for the SOC (nab-paclitaxel + gemcitabine combination), Antroquinonol in combination with SOC has much better median overall survival (mOS), six-month and twelve-month overall survival rates (OS rates). The overall survival rates for Antroquinonol combination therapy, standard treatment (nab-paclitaxel + gemcitabine), and gemcitabine monotherapy were 12.6, 8.5 and 6.7 months respectively; six-month overall survival rates were 86%, 67% and 55% respectively; and twelve-month overall survival rates were 60%, 35% and 22% respectively.

In comparison to the FOLFIRINOX treatment for metastatic pancreatic cancer, in terms of median overall survival and six-months overall survival rates; again the Antroquinonol in combination with SOC demonstrated superiority. Data showed that the overall survival (OS) between Antroquinonol combination with SOC and FOLFIRINOX were 12.6 and 11.1 months respectively; six-month overall survival rates were 86% and 76% respectively; twelve-month overall survival rates were 60% and 48% respectively. Compared to current first-line treatments, Antroquinonol in combination with SOC has also demonstrated better survival advantage.

The phase 2 study of Antroquinonol in combination with SOC demonstrates the high possibility of a new first-line agent for the treatment of Stage 4 metastatic pancreatic cancer. With its oral formulation and low side-effects, Antroquinonol can be an exciting addition to the current IV chemotherapies and immediately offer patients the possibilities of better treatment outcomes.