TAIPEI and SAN DIEGO, Aug. 14, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and coronaviruses, today announced that its novel oral drug, Silmitasertib, has been included in Taiwan's Center for Drug Evaluation: "CDE can Help: COVID-19 Regulatory Consultation Program". Senhwa and Taiwan's CDE have entered an agreement to facilitate the development of Silmitasertib for treating COVID-19 in Taiwan.
Taiwan's CDE is an instrumental partner of the Taiwan Food and Drug Administration (TFDA), assisting in drafting regulations and guidance, while also maintaining professional connections with other regulatory agencies in major countries. In response to the urgent public health need, the "CDE can Help" program was launched to provide scientific consultation and guidance on the regulations at each stage of development for COVID-19 treatments. Taiwan's CDE holds regular weekly meetings with selected program participants, performing reviews and providing feedback, to accelerate the progress of potential COVID-19 therapeutics. The program was paramount in the first domestic COVID-19 vaccine being granted Emergency Use Authorization (EUA) on July 19th, 2021.
"Under the guidance of Taiwan's CDE, Senhwa plans to launch a COVID-19 clinical trial in Taiwan to further examine the safety and human efficacy of Silmitasertib in treating COVID-19. With this collaboration Senhwa's drug, Silmitasertib, will have a greater opportunity to obtain EUA from TFDA," said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.
Silmitasertib is already provided under compassionate use for patients with severe COVID-19 in Taiwan (treatment was initiated in June 2021). Currently two Phase 2 Investigator Initiated Trails (IIT) are enrolling moderate and severe COVID-19 patients, respectively, in the United States.
Silmitasertib is a first-in-class small molecule drug that targets the CK2 (casein kinase 2) 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 in cancer patients. US FDA granted Silmitasertib 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 Biosciences
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.
Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications, are the core products in Senhwa Bioscience's pipeline. Clinical trials are currently ongoing in Australia, Canada, United States, Korea and Taiwan.
Visit Senhwa Biosciences' website for more details: www.senhwabio.com
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