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Taiwan COVID-19 drug gets positive review, clinical trials to advance

ROC Central News Agency

03/15/2021 12:41 PM

Taipei, March 15 (CNA) Taiwanese drug developer Senhwa Biosciences said Sunday that its investigational drug for the treatment of severe COVID-19 infections has received positive reviews from an independent monitoring group in the United States, and its clinical trials can go forward.

The oral drug Silmitasertib (CX-4945) is currently in phase two trial at Banner Health-University Medical Center in Phoenix, Arizona, which sponsored the research.

In an evaluation on March 11 of the data from the first batch of patients, the Data Monitoring Committee (DMC) said there was no need for modification of the trials.

Senhwa Biosciences can proceed to the recruitment of patients for the treatment of severe COVID-19, the company said in a release.

The DMC, also known as the Data and Safety Monitoring Board, is an independent group of clinical experts that monitors patient safety and/or treatment efficacy data during an ongoing clinical study.

According to the U.S. Food and Drug Administration's guidance, the DMC advises the sponsor on the continuing safety of trial subjects and those to be recruited to the trial, as well as on the continuing validity and scientific merit of the trial.

Senhwa Biosciences, which also has an operational base in San Diego, California, said it plans to complete the clinical trials of Silmitasertib (CX-4945) by the second quarter of this year.

(By Chang Chien-chung and Ko Lin)

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