Hocena (antroquinonol) / Golden Biotechnology - LARVOL DELTA

Antroquinonol mitigates Tau hyperphosphorylation, neuronal damage and cognitive impairments in a chronic cerebral ischemia rat model. (PubMed, Biomed Pharmacother) - "We also found that AQ inhibited HH-induced hyperphosphorylation of Tau by modulating protein kinases (p-GSK3β Y216 and p-mTOR), LC3II, and p-NRF2 proteins in cultured cells, suggesting roles in kinase regulation, autophagy, and antioxidation. These findings support AQ as a promise therapeutic candidate for treating CCI-related neurodegenerative disorders."

Journal • Preclinical • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Dementia • Hypoglycemia • Inflammation • Psychiatry

Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=52 | Active, not recruiting | Sponsor: Golden Biotechnology Corporation | Trial completion date: Mar 2024 ➔ Dec 2024

Combination therapy • Metastases • Trial completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

In Vitro Assessment of 4-Acetyl-Antroquinonol B and Erinacine A in Suppressing Breast Cancer-Induced Osteoclastogenesis. (PubMed, Int J Med Mushrooms) - "The results revealed that 4-AAQB and erinacine A effectively suppressed breast cancer-induced osteoclastogenesis and migration, and reduced TGF-β and MMP-9 production via Erk or JNK signaling transductions, specifically in breast cancer cells or in breast cancer cells-induced osteoclasts. Based on these findings, either 4-AAQB or erinacine A showed promise in preventing breast cancer metastases in bone."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor • MMP9 • TGFB1

Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=52 | Active, not recruiting | Sponsor: Golden Biotechnology Corporation | Trial completion date: Dec 2023 ➔ Mar 2024

Combination therapy • Metastases • Trial completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A phase I/II study of antroquinonol in combination with nab-paclitaxel and gemcitabine for patients with metastatic pancreatic cancer. (ASCO-GI 2024) - P1/2 | "In this phase I/II trial, antroquinonol plus Gem/Nab-P showed good efficacy in survival and less adverse events than a first-line strategy of Gem/Nab-P for mPC patients. Clinical trial information: NCT03310632. >Abbreviations: mPC, metastatic pancreatic cancer; Gem/Nab-P, gemcitabine and nab-paclitaxel.#, data from U.S. FDA-approved Supplemental New Drug Application (NDA 21660/S-037) dated March 21, 2013 for paclitaxel protein-bound particles for injectable suspension (albumin-bound), 100 mg/vial."

Clinical • Combination therapy • Metastases • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

ASCO GI 2024: Golden Biotech's Antroquinonol Shows Significantly Prolonged Survival in Untreated Metastatic Pancreatic Cancer Patients (PRNewswire) - P1/2 | N=52 | NCT03310632 | Sponsor: Golden Biotechnology Corporation | "Golden Biotechnology Corp...had unveiled the findings of its Phase II clinical trial investigating Antroquinonol (HOCENA) in combination with the standard of care (SOC): nab-paclitaxel + gemcitabine, as first-line treatment for metastatic pancreatic cancer....The treatment demonstrated significantly longer overall survival (median OS) and OS rates at both 6 and 12 months when compared to the standard of care Phase III study. The OS figures were 14.1, 8.5, and 6.7 months for (Antroquinonol + nab-paclitaxel + gemcitabine), (nab-paclitaxel + gemcitabine), and gemcitabine alone, respectively. The corresponding OS rates at 6 months were 85.5%, 67%, and 55%, while the rates at 12 months were 62.2%, 35%, and 22%....The trial results also showed an mPFS of 5.3 months and a 6-month PFS rate of 41.7% for Antroquinonol in combination with the standard of care drugs."

P2 data • Pancreatic Cancer

Guoding: Our company has been selected to publish the abstract of the Phase I/II clinical trial of Antroquinonol (Hocena) combined with standard treatment for pancreatic cancer at the 2024 ASCO GICancers Symposium. [Google transaltion] (Anue Juheng) - "The 2024 ASCO GI Cancers Symposium will be held in San Francisco, USA from January 18-20, 2024....Antroquinonol (Hocena) combined with standard pancreatic cancer treatment is the first treatment for metastatic pancreatic cancer. First-line drug (oral dosage form), the phase I/II clinical trial abstract will be published at the 2024 ASCO GI Cancers Symposium."

P1/2 data • Gastrointestinal Cancer • Oncology • Solid Tumor

Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=52 | Active, not recruiting | Sponsor: Golden Biotechnology Corporation | Trial primary completion date: Dec 2022 ➔ Dec 2023

Combination therapy • Metastases • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CA 19-9

A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Golden Biotechnology Corporation | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2022 ➔ Jun 2023

Trial completion • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Review of the Potential Benefits of Herbal Medicines, Small Molecules of Natural Sources, and Supplements for Health Promotion in Lupus Conditions. (PubMed, Life (Basel)) - "Among these molecules are artemisinin and its derivatives, antroquinonol, baicalin, curcumin, emodin, mangiferin, salvianolic acid A, triptolide, the total glycosides of paeony (TGP), and other supplements such as fatty acids and vitamins...This review can be helpful for researchers in designing new goal-oriented studies. It can also help practitioners gain insight into recent updates on supplements that might help patients suffering from lupus conditions."

Journal • Review • Immune Modulation • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Targeting RAS: Golden Biotech Announces Positive Results with Longer Survival Compared with Standard Treatments from Interim Analysis of Phase 2 Trial for Antroquinonol as 1st Line Treatment for Stage 4 Metastatic Pancreatic Cancer (PRNewswire) - P1/2 | N=52 | NCT03310632 | Sponsor: Golden Biotechnology Corporation | "Golden Biotechnology Corp...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....Key Results: Median progression-free survival (mPFS): 5.3 months; Median overall survival (mOS): 12.6 months; Six-month overall survival rate (OS rate): 86%; Twelve-month overall survival rate (OS rate): 60%."

P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Anti-Inflammatory Constituents of Antrodia camphorata on RAW 264.7 Cells Induced by Polyinosinic-Polycytidylic Acid. (PubMed, Molecules) - "The anti-inflammatory activity of all isolated compounds was assessed at non-cytotoxic concentrations. 4-Acetylantroquinonol B (1) was the most potent compound against poly I:C-induced NO production in RAW 264.7 cells with an IC value of 0.57 ± 0.06 μM."

Journal • Infectious Disease

Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=52 | Active, not recruiting | Sponsor: Golden Biotechnology Corporation | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2022 ➔ Dec 2023 | Trial primary completion date: Jun 2022 ➔ Dec 2022

Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CA 19-9

Clinical Benefits of Golden-Antrodia Camphorata Containing Antroquinonol in Liver Protection and Liver Fat Reduction After Alcoholic Hepatitis. (PubMed, Front Pharmacol) - "However, no clinical significance was observed in any of the safety parameters examined. Overall, these findings indicated that treatment with Golden-Antrodia camphorata exerted protective effects on liver function."

Journal • Hepatology • Inflammation

Safety of freeze-dried mycelia of Antrodia camphorata as a novel food pursuant to regulation (EU) 2015/2283. (PubMed, EFSA J) - "The NF mainly consists of carbohydrates, proteins and fats, and it contains numerous constituents, such as β-glucans, antroquinonol and triterpenoids...Based on a 90-day repeated dose toxicity study and a prenatal developmental toxicity study performed with the NF, the Panel derives a safe level of 16.5 mg/kg body weight per day. The Panel concludes that the NF, freeze-dried mycelia of Antrodia camphorata, is safe at the proposed use level for individuals aged 14 years and above."

Journal • Food Hypersensitivity

Chemical investigations and cytotoxic effects of metabolites from Antrodia camphorata against human hepatocellular carcinoma cells. (PubMed, Nat Prod Res) - "Bioassay-guided fractionation of the solid fermentation powder of A. camphorata KH37 led to the isolation of one new quinonol, antroquinonol Z (1), and nine known compounds (2-10)...Interestingly, two fractions showed cytotoxicity in HepG2 and Huh-7 cells, even better than compounds isolated from these fractions. The significant cytotoxicity of partially purified samples from A. camphorata KH37 exhibited a potential for developing alternative or complementary therapeutics against hepatoma."

Journal • Fatigue • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Urokinase plasminogen activator induces epithelial-mesenchymal and metastasis of pancreatic cancer through plasmin/MMP14/TGF-β axis, which is inhibited by 4-acetyl-antroquinonol B treatment. (PubMed, Phytomedicine) - "Accordingly, to extent of our knowledge and previous studies, we demonstrated that 4-AAQB is an anti Pan-Cancer drug, and may inhibit pancreatic cancer EMT and metastasis and serve as a new therapeutic approach for patients with late-stage pancreatic cancer."

Journal • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • MMP14 • TGFB1

A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Golden Biotechnology Corporation | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Application of Multiple Strategies to Improve the Production of the Potential Cancer Drug 4-Acetylantroquinonol B (4-AAQB) by the Rare Fungus Antrodia cinnamomea. (PubMed, Appl Biochem Biotechnol) - "The combination of these multiple strategies resulted in the yield of 4-AAQB to 17.27 mg/g dry cell weight with a titer of 140 mg/L, which was the highest titer of 4-AAQB reported so far. It showed that the combination of these strategies had a significant promotion on 4-AAQB production by A. cinnamomea, which laid a good foundation for its large-scale production and also provided a viable method for the cultivation of other rare fungi."

Journal • Oncology

4-Acetylantroquinonol B enhances cell death and inhibits autophagy by downregulating the PI3K/Akt/MDR1 pathway in gemcitabine-resistant pancreatic cancer cells. (PubMed, Oncol Lett) - "Vascular endothelial growth factor A (VEGFA) expression, cell migration, and invasion were also inhibited by the 4-AAQB incubation. Overall, this combination treatment strategy might represent a novel approach for GEM-resistant pancreatic cancer."

Journal • Gastrointestinal Cancer • Genetic Disorders • Hepatology • Obesity • Oncology • Pancreatic Cancer • Solid Tumor • ABCB1 • ABCC1 • HMGB1

Antroquinonol administration in animal preclinical studies for Alzheimer's disease (AD): A new avenue for modifying progression of AD pathophysiology. (PubMed, Brain Behav Immun Health) - "Improvement of memory impairment was also reported when Antroquinonol (D3) was administered at late stage (9 months). Since Antroquinonol has been used without adverse effects in previous successful clinical trials, this drug may offer a new avenue of treatment to modify AD development and progression."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Oncology • IL1B • TNFA

4-Acetylantroquinonol B Suppresses Prostate Cancer Growth and Angiogenesis via a VEGF/PI3K/ERK/mTOR-Dependent Signaling Pathway in Subcutaneous Xenograft and In Vivo Angiogenesis Models. (PubMed, Int J Mol Sci) - "Serum or vascular endothelial growth factor (VEGF)-induced VEGF receptor 2 (VEGFR2), phosphoinositide 3-kinase (PI3K)/Ak strain transforming (Akt), and extracellular signal-regulated kinase ½ (ERK ½) phosphorylation were attenuated by 4AAQB in both PC3 and HUVEC. In conclusion, 4AAQB is a potential candidate for prostate cancer therapy."

Journal • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • KDR

Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients (clinicaltrials.gov) - P2; N=124; Completed; Sponsor: Golden Biotechnology Corporation; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • PCR

Genetic evidence for the requirements of antroquinonol biosynthesis by Antrodia camphorata during liquid-state fermentation. (PubMed, J Ind Microbiol Biotechnol) - "Of the modification steps, prenylation of UQ0 is the key step of AQ biosynthesis during LSF. The result will help us to understand the genetic evidence for the requirements of antroquinonol biosynthesis in A. camphorata."

Journal

Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2; N=52; Recruiting; Sponsor: Golden Biotechnology Corporation; Trial completion date: Jun 2021 ➔ Jun 2022; Trial primary completion date: Jun 2021 ➔ Jun 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Cancer antigen 19-9 • MRI