Bloomberg

Anti-viral and Anti-Inflammatory Response: GoldenBiotech’s Antroquinonol Receives

FDA Approval on COVID-19 Phase 2 Trial in USA

Jul.1, 2020‎

TAIPEI, July 1, 2020 /PRNewswire/ — Golden Biotechnology Corp.

(GoldenBiotech, 4132.TWO), a leading Taiwanese biopharmaceutical company,announced that the FDA approved its investigational new drug (IND) application for a Phase II clinical trial of Antroquinonol (Hocena®) on COVID-19 patients in USA. GoldenBiotech has also applied for the US BARDA (Biomedical Advanced Research and Development Administration) CoronaWatch meeting. Future developmental planning of Antroquinonol in COVID-19 include joining the COVID-19 Candidate and Technologies Portal of the National Institutes of Health (NIH) and applying for the US emergency authorization (EUA) once it exhibits significant clinical results, all to expedite the meeting of the urgent market demand.

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.

Dr. Today Su, Chief Executive Officer at GoldenBiotech, stated, “At present, physician can only provide supportive care such as oxygen supplementation, mechanical ventilation, and/or extracorporeal membrane oxygenator (ECMO) based on the clinical symptoms of the patients or enroll them in available clinical trials. Clearly, new and more effective drugs are still in need to fight the pandemic. Thus, it is imperative to provide immediate and ample supply to the world should our study improve the efficacy of any newly authorized treatments recommended as standard of care (SoC) for COVID-19.”

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.

FORWARD-LOOKING STATEMENTS

The statements contained herein may contain certain forward-looking statements relating to Golden Biotechnology Corp. (GoldenBiotech) (the “Company”) that are based on the current beliefs and expectations of the Company’s management as well as assumptions made by and information currently available to the Company’s management. These forward-looking statements include, but are not limited to, statements relating to the Company’s business prospects, future developments, trends and conditions in the industry and geographical markets in which the Company operates. These statements can be identified by the use of words such as “anticipate,” “estimate,” “believe,” “continue,” “could,” “intend,” “may,” “plan,” “potential,” “predict,” or similar words, as well as the negatives of these terms or other comparable terms. However, the absence of these words does not mean that the statements are not forward-looking.

These forward-looking statements are, by their nature, subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

These forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to update or reflect subsequent events or circumstances, changes in expectations or the occurrence of unanticipated events. All forward-looking statements herein are qualified by these cautionary statements and there can be no assurance that the actual results or anticipated developments will be realized or, even if substantially realized,that they will have the expected consequence to or effects on the Company’s business or operations.

Cision View original

content:http://www.prnewswire.com/news-releases/anti-viral-and-anti-inflammatory-response-goldenbiotechs-antroquinonol-receives-fda-approval-on-covid-19-phase-2-trial-in-usa-301086715.html

SOURCE Golden Biotechnology Corp.