Golden Biotechnology Corporation (GBC)(TW4132) was founded in 2002, is an innovative drug discovery and herbal supplement company dedicated to enhance lives by developing high quality products that prevent and treat diseases. The ubiquinone-like structure of Antroquinonol® (Hocena®) was discovered in 2006 by GBC in Taiwan. This small molecule has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer (#14-4608), acute myeloid leukemia (AML) (#15-4763) and hepatocellular carcinoma (#15-4881) in 2015. European Commission also grants orphan drug designation to Antroquinonol® for the treatment of pancreatic cancer in early 2017. Furthermore, Antroquinonol® was awarded in pharmaceutical sector of Advance Queensland – Johnson & Johnson Innovation QuickFire Challenge for its potential as a treatment for Alzheimer’s disease in 2016.
For global IP protection strategy, the patent of Antroquinonol® covers all aspects such as total synthesis processes, structure relative analysis, target diseases, and possible forms of derivatives and metabolites. As of April 2017, Antroquinonol® and its relevant therapeutic applications have been granted more than 100 patents over 40 countries/regions worldwide, including major markets such as the US, the EU, Japan, South Korea, Taiwan, and China. GBC has its own manufacturing plants to manufacture Antroquinonol® and finished product for use in clinical trials. The plants that manufacture Antroquinonol® and finished product for clinical use has been accredited with PIC/S GMP certification.
In regard to the clinical status of Antroquinonol®, many clinical researches including oncology and non-oncology trials have already started. For oncology trials, the Phase 2 global multicenter trials were on patients with stage IV NSCLC who have failed two lines of anti-cancer therapy. The trial passed the first DSMB review in 2016 and finished in 2Q2018 with high safety and exceeding overall 72% DCR( Disease Control Rate) in clinical data.
GBC received USFDA IND approval in 2017 to begin a Phase 1/2 clinical trial of Antroquinonol® in combination with gemcitabine (Gemzar®) and nab-paclitaxel (Abraxane®) as first line treatment for patients with metastatic pancreatic cancer. A Standard regimen of gemcitabine (Gemzar®) with nab-paclitaxel (Abraxane®) is the most common first-line therapy option for pancreatic cancer. According to the results of the clinical trial, patients who received this combination therapy succeed in a median overall survival (mOS) of 8.5 months, compared with 6.7 months for patients treated with gemcitabine alone. Obviously there is still much more room for improvement on the effectiveness for pancreatic cancer so GBC will devote to the study of novel Antroquinonol regimens and to benefiting the quality of life by decreasing adverse effects. It is inferred that patients with early-stage pancreatic cancer will be able to enroll in this clinical trials.
For non-oncology trials, the Phase 2 clinical trial of Antroquinonol® in the treatment of hypercholesterolemia and hyperlipidemia was kick-off in 2015 in Taiwan. This is a double-blind clinical study with title “Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia”.
The trial has been finished by August and decoded in September 2018 with the success in unblinding of clinical data. The main observational indicator was the changes in the subject for Triglyceride (TG). The results showed the level of triglyceride(TG) value in the blood for patients taking Hocena (Antroquinonol) were significantly reduced.
For secondary observation indicators such as: (a) arteriosclerosis index (arm brachial wave propagation rate, baPWV) (b) fatty liver parameter changes (3) Low-density lipoprotein cholesterol (LDL-C) all demonstrated statistically significant effects. Other blood lipid parameters such as total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and LDL/HDL ratios all showed an improvement trend.
Other from patents in varies of different cancers treatment , regarding the patents relating to non-oncology sectors, such as liver disease, lipid metabolism disease and cardiovascular disease, Golden Biotechnology Corp. also received the approval of patents for Antroquinonol in the treatment in fatty liver, arteriosclerosis diseases etc.
In addition, the IND application for two phase 2 PoC clinical trials in patients with chronic hepatitis B virus (HBV) infection and atopic dermatitis(AD) respectively have been approved by TFDA . These two trials are also double-blind clinical studies and are expected to be finished by end of 2019.
GBC welcomes opportunities to collaborate with global strategic partners in the pharmaceutical industry in further enhancing the research, development, and commercialization of Antroquinonol®.