Senhwa's Silmitasertib, COVID-19 Drug Candidate, Receives Positive Interim Review from Data Monitoring Committee to Proceed

News provided by

Aug 31, 2021, 07:00 ET

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 11^thwhen 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 23^rd 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).

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. It is safe and well-tolerated in humans. In addition to COVID-19, Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase II studies of Silmitasertib. US FDA granted Silmitasertib key drug designations, an Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, a Rare Pediatric Disease Drug Designation for the treatment of Medulloblastoma in July 2020, and an eIND for the treatment of a patient with severe COVID-19 in August 2020.

About Senhwa Bioscience

Senhwa Biosciences, Inc. is a leading clinical-stage company focusing on developing first-in-class, next-generation DNA Damage Response therapeutics for patients with unmet medical needs in oncology. Headquartered in Taiwan, with an operational base in San Diego, California, Senhwa is well-positioned to oversee the development of its compounds.

Development is currently focused on two lead products Silmitasertib (CX-4945) and Pidnarulex (CX-5461) with novel mechanisms of action and for multiple indications. Clinical trials are currently ongoing in Australia, Canada, United States, Korea and Taiwan.

Visit Senhwa Biosciences website for more details: www.senhwabio.com

SOURCE Senhwa Biosciences, Inc.