COVID-19 Breakthrough: Cancer Drug Silmitasertib Proves Effective In Treating Severe COVID-19 Pneumonia With Patient Discharged After Five Days Of Treatment
: Clinical-stage biopharmaceutical company Senhwa Biosciences that is based in Taiwan with offices in San Diego has announced that its investigational drug, Silmitasertib has demonstrated remarkable effectiveness after the first patient with severe COVID-19 demonstrated remarkable recovery after using the drug.
Senhwa Biosciences is a company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer and on the 27th
of August, 2020, the U.S. Food and Drug Administration (FDA) approved the first emergency IND and authorized use of Silmitasertib in a patient with severe COVID-19 pneumonia requiring supplemental oxygen.
The COVID-19 patient in Phoenix, Arizona with severe conditions had been treated with multiple therapeutics, including Remdesivir, Dexamethasone, Ceftriaxone, Azithromycin and Enoxaparin within two weeks, but remained hypoxic and required up to 2 liters of supplemental oxygen daily.
Due to the fact that none of the available therapeutics working well for this patient, the clinical investigators decided to try Senhwa's investigational drug, Silmitasertib.
It was observed that within 24 hours of the first dose the patient showed significant clinical improvement and the oxygen requirement was weaned to room air. The patient was discharged from the hospital five days after starting Silmitasertib.
Dr Marilyn Glassberg Csete, MD, Chief of Pulmonary, Critical Care, and Sleep Medicine at University of Arizona College of Medicine/Banner-University Medical Center Phoenix and Dr Esa Rayyan, DO, her co-investigator, are now looking for five to ten more patients with severe COVID-19 to treat with Silmitasertib with a plan for a randomized clinical trial in the near future.
The investigators will shortly be publishing a preprint version of the clinical study online for peer-review and publication into a medical journal.
Dr John Soong, the Chief Medical Officer of Senhwa Biosciences. Told Thailand Medical News, "This is the first individual in the world to receive Silmitasertib for the SARS-CoV-2 coronavirus, and it seems to have worked. It is only one case, and it is still early to know how well the treatment will do in others, but if the same result is repeated in other patients, it will give us an opportunity to significantly reduce the average time of COVID-19 patient hospitalization and reduce the burden on healthcare systems.”
Dr Benny T. Hu, Chairman of Senhwa Biosciences added, "This first patient that received Silmitasertib was discharged in five days! We are encouraged by the patient's strong response to Silmitasertib and will make every effort to provide our drug to critically ill COVID-19 patients.”
It has also been reported that Banner-University Medical Center Phoenix is also planning to start a Phase 2, Investigator-Initiated Trial (IIT) of 40 patients.
Yet another Phase 2 IIT will be conducted at the Center for Advanced Research and Education (CARE) in Gainesville, Georgia. The CARE trial will seek to enroll 10 patients once it is approved by the FDA.
The cancer drug Silmitasertib is a first-in-class small molecule drug that target
s CK2 and acts as a CK2-inhibitor. Silmitasertib is safe and well-tolerated in humans. To date, three Phase I trials of Silmitasertib in cancer patients have been completed; currently, there are one ongoing Phase I and two ongoing Phase II studies of Silmitasertib.
In December 2016, Silmitasertib was granted Orphan Drug Designation by the US FDA for the treatment of Cholangiocarcinoma. In July 2020, Silmitasertib was granted Rare Pediatric Disease Designation (RPD) in Medulloblastoma by the US FDA.
Thailand Medical News will be covering details of the preprint clinical study report which will also detail the possible mechanisms of the drug in the case of treating COVID-19 once the publication is available.