Senhwa Biosciences Silmitasertib / Basal Cell Carcinoma Trial Completed 1st Patient Enrollment

TAIPEI, Taiwan and SAN DIEGO, April 17, 2019 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492) announced today that the clinical trial of Silmitasertib (CX-4945) for the treatment of Basal Cell Carcinoma (BCC) has enrolled its first patient at Texas Oncology, Texas, USA. The trial will be carried out simultaneously across six clinical centers in the United States.

BCC is the most common type of skin cancer. In the United States, the annual incidence rate of newly diagnosed BCC is about 4.3 million with approximately 3,000 people dying from BCC annually. BCC typically occurs in the middle-aged, particularly individuals over the age of 40. Most basal cell carcinomas can be surgically removed; however, for inoperable tumors there are two approved targeted drug options: Erivedge, known as Vismodegib, and Odomzo, known as Sonidegib. Both of these drugs are SMO inhibitors. 

Vismodegib is the first targeted drug globally marketed for the treatment of patients with metastatic, locally advanced, inoperable or radiotherapy unresponsive BCC. Vismodegib, which was developed by US pharmaceutical, Genentech, Inc., was approved for marketing in January 2012. Available therapies are limited for patients once they progress on SMO inhibitors.                                         

According to GlobalData, in 2018 Genentech's global sales of Erivedge was 258 million Swiss Francs (260 million USD). Cowen & Co.'s predicts that by 2022, peak sales of Erivedge will reach 533 million USD. As for Sonidegib, Sun Pharmaceutical Industries has acquired it from Novartis to grow its drug portfolio in the late 2016 for 175 million USD. The peak sales of Sonidegib will reach 653 million USD by 2024 according to GlobalData.   

About Silmitasertib (CX-4945)

Silmitasertib is a first-in-class small molecule drug that targets Casein Kinase 2 (CK2), a protein involved in the DNA repair mechanism of cancer cells. A Phase I/II study has shown that Silmitasertib achieved clinical benefit as a single-agent CK2 inhibitor, resulting in stable disease and allowing several patients to tolerate extended treatment. A combination of Silmitasertib with DNA-damaging agents such as gemcitabine (Gemzar) plus cisplatin (Platinol) has shown synergistic improvements in the efficacy of Cholangiocarcinoma (CCA) treatments. In December 2016, in association with the treatment of CCA, the FDA (US) granted Silmitasertib Orphan Drug Designation.

About Senhwa

Senhwa Biosciences, Inc. (TPEx:6492) is a leading clinical stage company focusing on developing first-in-class, Next Generation DNA Damage Response (DDR) 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 their compounds.

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

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