BIO Asia Taiwan 2020 Exhibition Highlights-“GoldenBiotech Can Help!” Featuring Progress of Antroquinonol on COVID-19 Phase 2 Trial in USA
TAIPEI, July 29, 2020. Golden Biotechnology Corp. (GoldenBiotech, 4132.TWO), a leading Taiwanese biopharmaceutical company, completed in participation of the 2020 BIO Asia Taiwan Exhibition on Jul.23 till 26 in Taipei. BIO Asia–Taiwan 2020 goes ahead as scheduled with a new model: “BIO Asia–Taiwan 2020 Online + Live”, which was the first and biggest major industry gathering in Asia since the onset of this global Covid-19 pandemic crisis. GoldenBiotech launched its theme “GoldenBiotech Can Help!” as FDA approved its investigational new drug (IND) application for a Phase 2 clinical trial of Antroquinonol (Hocena®) on COVID-19 patients in USA. This is the first and only Taiwanese new drug to get FDA approval on proceeding Covid-19 clinical trial.
The trial is expected to be completed before the end of 2020 to accelerate it’s time to the market with its distinguished comprehensive benefits of anti-viral, anti-inflammation and anti-fibrosis effects.
The ongoing progress of its clinical studies of oncology including NSCLC, pancreatic cancer and AML etc. were also showcased their new development during the exhibition as well as company presentation by virtual and live in the annual important event.
The Phase II trial will be a randomized, double-blinded, placebo-controlled study of Antroquinonol as a potential treatment option for mild-to-moderate pneumonia in COVID-19 patients, as measured by the proportion of patients alive and free of respiratory failure (i.e., need for invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or extracorporeal membrane oxygenation [ECMO]) on Day 14.
Currently there is no drug in development for treating Covid-19 that can effectively improve the severe inflammatory response induced by the virus nor the overall survival rate. We can see that by far there is no single drug that can simultaneously fight against the COVID-19 virus (SARS-CoV2) and the symptoms induced. Combination therapies adopted by other clinical trials may solve the shortcomings of single-drug therapies with slightly better efficacy, but the higher risk of adverse effects is inevitable.
Antroquinonol was found to reduce viral nucleic acid replication and viral protein synthesis in both cell and animal experiments. Prevention of organ and tissue damage was also observed with Antroquinonol when treating mice with excessive inflammation. The characteristic of multiple effects makes Antroquinonol more advantageous than other antiviral and/or anti-inflammatory drugs. GoldenBiotech is now actively promoting the Phase II study for COVID-19 in the hopes that Antroquinonol will not only improve the symptoms of COVID-19, but also minimize the possible side effects that may be induced during the treatment process.
For other oncology indications, the Antroquinonol monotherapy study in Stage IV NSCLC patients who have failed at least two lines of anti-cancer therapy has shown longer progression free survival (PFS) and a high disease control rate. A Phase I/II study is currently in progress to evaluate the treatment efficacy of combining Antroquinonol with Nab-paclitaxel and Gemcitabine for the first-line treatment for stage IV metastatic pancreatic cancer patients. The ongoing Phase II study in relapsed AML patients who are restricted from intensive therapy showed positive preliminary results.
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