GoldenBiotech HOCENA Granted Compassionate Use for Treatment of Covid-19 Patients
Exhibitor: GOLDEN BIOTECHNOLOGY CORP.
Booth No.: R410
GoldenBiotech HOCENA Granted Compassionate Use for the Treatment of Covid-19 Patients
Golden Biotechnology Corp.(TPEx:4132)(“GoldenBiotech”, GBC), a leading Taiwanese biopharmaceutical company, announces that its investigational new drug HOCENA(antroquinonol) has been granted the " Compassionate Use " in July 1st to be used in the treatment of mild to moderate Covid-19 patients in the applied hospital. The first approval were allowing for 100 patients treatment courses.
In Jun, 2021, the new drug passed the second DMC review for its enrollment of 80 patients and received the recommendation that the trial can continue and can extend to enroll those severe patients without invasive ventilation or high flow oxygen support needed for its multinational Covid-19 Phase 2 clinical trial of the new drug Antroquinonol (HOCENA). The DMC review was conducted by the US FDA approved external independent data monitoring committee (DMC). The trial is currently undergoing in 15 trial centers covering the United States, Peru and Argentina totally
Totally 174 patients will be enrolled in the Phase 2 Covid-19 trial for Antroquinonol (HOCENA®). The result of first interim of 20 patients admitted has been reviewed by DMC and received “positive response” from DMC on January 16. For the expansion of the trial, 15 medical centers including top US medical hospitals which will shorten the completion time of phase 2 clinical trial and time to apply the US FDA emergency use authorization (EUA) when significant trial results are achieved.
The Phase 2 trial is a randomized, double-blinded, placebo-controlled study of Antroquinonol as a potential treatment option for mild-to-moderate pneumonia in COVID-19 patients. The Primary Outcome Measures of the trial set to check the “Recovery Ratio” [Time Frame: 14 day] for the proportion of patients who are alive and free of respiratory failure (e.g., no need for invasive mechanical ventilation, noninvasive ventilation, high flow oxygen, or ECMO) on Day 14. The Secondary Outcome Measures set to check the “Time to 2-point improvement” [Time Frame: 28 day], clinical change score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale, duration of hospitalization [Time Frame: 28 day] as time for patient discharge and the “Time to virological clearance” [Time Frame: 28 day] which is measured as study days from start of treatment to first negative SARS CoV 2 PCR test.
** 2021 BIO Asia- One-on-One Partnering , Please Contact:
Dr. Archer Hung / BD Manager / Golden Biotechnology Corporation
Welcome visit us at Booth R 410 ( Pharmaceuticals Area ) or brouse the on-line virtual booth of Golden Biotechnology Corp..
Media Contact :
Golden Biotechnology Corp.
Tel: + 886 2 2808-6006
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