GoldenBiotech Oral COVID-19 Drug Antroquinonol Agreed by FDA to Extend Recruiting Severe Patients
Exhibitor: GOLDEN BIOTECHNOLOGY CORP.
Booth No.: R410
TAIPEI, Sept.16, 2021-- Golden Biotechnology Corp.(TPEx:4132) ("GoldenBiotech", GBC), a leading Taiwanese biopharmaceutical company, announces that its oral investigational new drug Antroquinonol (HOCENA®) has made headway with COVID-19 treatment development in more broader clinical trial patients permitted in inclusion severity.
On Aug. 30, 2021, pursuant to clinical trial protocol amended following the recommendation of the approved second interim DMC (Data Monitoring Committee) review, GoldenBiotech was noticed by CRO that the Food and Drug Administration(FDA) agreed that its ongoing phase 2 trial of Antroquinonol for treating COVID-19 patients can be extended recruiting from the mild or moderate hospitalized patients to the severe hospitalized COVID-19 patients who need non-invasive oxygen support. The total trial subjects will remain the same, 174 patients in total.
The trial recruiting is expedited in full swing covering the USA, Peru and Argentina where the new upheaval pandemic is rampant with highly transmitted SARS-CoV2 variants. "So far, there is no oral drug approved or receives the EUA from the FDA for COVID-19 treatment. Our recent progress will help shorten the completion time of our phase 2 clinical trial and time to apply with the US FDA emergency use authorization (EUA) when the significant trial results are achieved," quoted by Alex Liu, the Chairman of Golden Biotechnology Corp.
Currently, Golden Biotechnology Corp. is the only Taiwanese company that undergoes the formal clinical trial for COVID-19 treatment in multi-national centers and follows the FDA guidance for COVID-19 trials to set the trial as randomized, double-blinded and placebo-controlled study.
The new permitted extensive enrollment from mild, moderate to severe patients in the trial will assess the efficacy of recovery rate and prevent the milder COVID-19 patients becoming more severe conditions which will ease the heavy loading of the medical systems.
Antoquinonl stands out from current many anti-viral drugs which it recruits the COVID-19 confirmed patients consistent with pneumonia from their chest X-ray or computerized tomography (CT) scan. The sign of viral pneumonia indicates the inflammation and the tendency of severity which is lack of effective cure and with poor prognosis. People with liver disease are the vulnerable group to COVID-19 infection even the lower and slower antibody protection will produce after their receiving vaccination acc. to the recent studies.
Welcome to Bio Asia Taiwan 2021 Exhibition, Date: 11/4~11/7 at Taipei Nangang Exhibition Center, Hall 2,
4th Floor, Pharma District, GoldenBiotech at Booth No. R410
Golden Biotechnology Corp.
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