TAIPEI and SAN DIEGO, Aug. 31, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced that its oral new drug, Silmitasertib, had received a positive feedback from an Independent Data Monitoring Committee (DMC) for their interim review of Phase II Investigator Initiated Trial in patients with severe COVID-19, conducted at Banner Health-University Medical Center in Phoenix, Arizona, and Banner Health-University Medical Center in Tucson, Arizona.
The DMC, also known as the Data and Safety Monitoring Board, is an independent group of clinical experts that monitors patient safety and treatment efficacy data during ongoing clinical studies. The committee's initial evaluation occurred on March 11th when they reviewed data from the first batch of randomized patients, the DMC stated that there was no need for trial modifications. An additional interim data evaluation on August 23rd of twenty patients, continues to bolster the decision to proceed with the recruitment of patients with severe COVID-19, as per the overall study design, again without any protocol modifications needed.
"We are pleased to know that DMC did not raise any safety concerns for Silmitasertib and patient enrollment can advance as per the protocol," said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.
Senhwa's Silmitasertib is safe, easy for use via its oral form. As a CK2-inhibitor, it is thought to inhibit active viral replication in the infected cells, thereby preventing the virus from spreading to nearby cells and also reduces the body's overactive inflammatory response to Covid-19 infection. Silmitasertib is also provided under compassionate use for patients with severe COVID-19 in Taiwan (initiated in June 2021).