Far-Eastern Memorial Hospital

TAIPEI and SAN DIEGO, March 20, 2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that their first patient has been successfully dosed in the phase II study of Silmitasertib (CX-4945) in patients with community-acquired pneumonia (CAP) associated with viral infection in Taiwan. This trial is to investigate whether early medical intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses. This phase II trial is led by an inter-hospital team specializing in infectious diseases, with extensive experiences in carrying out large-scale international clinical trials for various anti-viral new drugs. The study team consists of five well-known hospitals including National Taiwan University Hospital, National Taiwan University Cancer Center, Far Eastern Memorial Hospital, Tri-Service General Hospital and Taoyuan General Hospital, Ministry of Health and Welfare. According to the latest warning issued by the World Health Organization (WHO) that the globe may face another wave of pandemic of Disease X, possibly caused by the evolution of influenza, novel coronavirus strains, or a new pathogen unknown to humans. In addition, the reported case of the first human infection with avian flu and subsequent death in mainland China earlier this year promoted the WHO to conduct a risk assessment for transmission. Silmitasertib (CX-4945) developed by Senhwa Biosciences possesses a novel mechanism that targets human host cells, making it less susceptible to the effects of viral mutations. The purpose of this trial is to give early medical intervention in the course of the disease with Silmitasertib (CX-4945) as to prevent the progression of CAP, to avoid hospitalization and enhance the subject's clinical condition, while reducing the risks associated with elevated cytokine release related to infections of new coronaviruses or influenza viruses. Furthermore, compared to Silmitasertib (CX-4945), the next-generation drug CX-8184 exhibits higher activity and better neutralizing and inhibiting abilities against viruses. It is currently being developed to be administered directly to the lungs, aiming to become a novel treatment with convenient usage and broad-spectrum antiviral potential, if successful. About Silmitasertib Silmitasertib is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor. Clinical studies thus far have shown Silmitasertib to be safe and well-tolerated in humans and is easily administered with its oral formulation. Silmitasertib is currently under development through several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I and one Phase I/II study of Silmitasertib in oncology, as well as two Phase II trials in infectious diseases, have been completed. The US FDA has granted Silmitasertib Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma. About Senhwa Biosciences Senhwa Biosciences, Inc. is a leading clinical-stage company focused on developing first-in-class, next-generation DNA Damage Response therapeutics and seeks to address unmet medical needs in oncology and infectious diseases. 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 and Taiwan. Visit Senhwa Biosciences' website for more details: SOURCE Senhwa Biosciences, Inc.

TAIPEI and SAN DIEGO, Dec. 26, 2023 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that Taiwan Food and Drug Administration has approved its Phase II IND application of Silmitasertib (CX-4945) to treat patients with community-acquired pneumonia (CAP) caused by viral infection. The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses. This trial will be led by an inter-hospital team, which is specialized in infectious diseases and possesses extensive experiences in carrying out large-scale international clinical trials for various anti-viral new drugs, across five well-known hospitals including National Taiwan University Hospital, National Taiwan University Cancer Center, Far Eastern Memorial Hospital, Tri-Service General Hospital and Taoyuan General Hospital, Ministry of Health and Welfare. Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. CK2 modulates inflammatory pathways, including NF-κB, PI3K–Akt–mTOR, and JAK–STAT. Inhibition of CK2 by Silmitasertib diminishes the secretion of IL-6 and MCP-1 (Rosenberger et al.). Silmitasertib treatment also reduces the expression of TNF-α and CCL4 in NiSO4-stimulated MoDCs (Bourayne et al.). "Senhwa regards this phase II as the proof-of-concept study to demonstrate Silmitasertib can be a therapeutic strategy that are not restricted to only a specific viral infection, but applicable to various viruses," said Jin-Ding Huang, CEO of Senhwa Biosciences, Inc. The global market for related therapeutic drugs has exceeded a value of over $120.6 billion USD in 2020 and it's projected to grow at a CAGR of 7.88% and reach more than $339 billion USD by 2030 according to market research. About Silmitasertib Silmitasertib is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor. Clinical studies thus far have shown Silmitasertib is safe and well-tolerated in humans and is easily administered with its oral formulation. Silmitasertib is currently under development through 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 while two other Phase I and II studies of Silmitasertib are still ongoing. The US FDA has granted Silmitasertib Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma. About Senhwa Biosciences Senhwa Biosciences, Inc. is a leading clinical-stage company focused on developing first-in-class, next-generation DNA Damage Response therapeutics and seeks to address unmet medical needs in oncology and infectious diseases. 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 and Taiwan. Visit Senhwa Biosciences' website for more details: SOURCE Senhwa Biosciences, Inc.

China Medical University Hospital in Taichung, Taiwan has been recently validated for three HIMSS Digital Maturity Models: Stage 7 for the Infrastructure Adoption Model (INFRAM), revalidation of Stage 7 for the Electronic Medical Record Adoption Model (EMRAM), and Stage 6 for the Adoption Model for Analytics Maturity (AMAM). The INFRAM measures an organisation's maturity in infrastructure and associated technology capabilities. The EMRAM measures their clinical outcomes, patient engagement, and clinician use of EMR technology, while the AMAM gauges their analytics capabilities. WHY IT MATTERS CMUH is the first hospital in Taiwan to be validated for Stage 7 INFRAM. It was able to achieve this feat in just four months after achieving Stage 6. It attributed its achievement to its infrastructure strategy which took inspiration from the Chinese Zodiac. The hospital is also the first in the country to be validated for Stage 6 AMAM. It was able to demonstrate some mature applications of analytics, including the analysis of medication expenses that helped it realise an annual cost savings of approximately NT$ 200 million ($6.2 million). Another example is its ARDiTeX (ARDS Technology System) visualisation panel that is used in the Respiratory ICU. It enabled the reduction in 28-day mortality among diagnosed patients with ARDS (Acute Respiratory Distress Syndrome). Additionally, CMUH was revalidated for Stage 7 of the EMRAM. To meet the requirements of this stage, the hospital introduced major changes in its EMR system. These include the implementation of the Electronic Medication Administration Record, integration of records across multidisciplinary teams, and establishing interoperability with the Med-cloud database of Taiwan's National Health Insurance. HIMSS also recognised its antimicrobial AI platform, the Intelligent Anti-Microbial System ( i.A.M.S. ), as a noteworthy use of the EMR. It is a four-in-one AI-driven platform that identifies drug-resistant strains and predicts and monitors the risk of infectious sepsis and mortality. It also makes smart drug dosage recommendations and automatic comparisons of drug-drug interactions and allergy history. In just three months after its implementation in June 2021, i.A.M.S. helped cut the mortality rate due to sepsis by 7.1%, compared to 13.4% in the same period in the previous year. To date, CMUH has developed 16 AI-driven services and 50 dashboards based on the Microsoft Power Business Intelligence platform, which are all implemented broadly across clinical and operational areas. THE LARGER TREND CMUH joins a growing group of Taiwanese healthcare providers that have been validated for the EMRAM. Its revalidation follows Changhua Christian Hospital which was also validated for Stage 7 EMRAM a few months ago. The Kaohsiung Medical University Chung-Ho Memorial Hospital is the latest hospital in Taiwan to be validated at Stage 6, followed by Far Eastern Memorial Hospital last year. Taichung Veterans General Hospital and Tungs' Taichung MetroHarbor Hospital have also achieved Stage 6 for this model. CMUH’s AMAM and INFRAM validations also follow those of Samsung Medical Center, the first healthcare provider in Asia-Pacific to achieve Stage 6 AMAM and Stage 7 INFRAM . ON THE RECORD Dr Wei-Cheng Chen, chief secretary of CMUH, shared that they turned to international standards and models for inspiration and validation in their efforts towards digital transformation. "During these years – without any role models of smart hospitals in Taiwan – we observed and learned to figure out what a smart AI hospital is. We found that HIMSS provides a systematic approach and clear criteria to achieve this goal. That’s why CMUH strongly endorses HIMSS to guide our directions and find out our weaknesses," Dr Chen shared. Further explaining their vision of becoming a smart AI hospital, CMUH Superintendent Dr Der-Yang Cho said: "At CMUH, our smart healthcare vision is anchored in a patient-centred approach, aiming to refine clinical processes and elevate care quality through data analytics and AI. This approach, continuously evolving with our digital transformation journey, integrates advanced AI and BI to deliver more precise, efficient, and reliable medical solutions like the i.A.M.S." "Superintendent Dr. Cho underscores our commitment to 'useful, practical, and favoured' tools and projects that enhance patient care and quality of life. Through these efforts, we aspire to make our healthcare services not only effective and efficient but also preferred and valued by our patients," Vice Superintendent and CMUH professor Oscar K. Lee added.