- Study will treat 40 COVID-19 infected patients hospitalized with moderate-to-severe symptoms
- Efficacy endpoints include viral shedding and resolution of symptoms
PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has received approval from the Institutional Review Board (IRB) at Rabin Medical Center to initiate a pilot clinical study of its drug candidate Piclidenoson for the treatment of moderate-to-severe symptoms in coronavirus (COVID-19) infected patients.
On March 23, 2020, Can-Fite announced it submitted Piclidenoson for a COVID-19 compassionate use program to the IRB at Rabin Medical Center. Upon review, the IRB recommended that Can-Fite advance into a full clinical study. Can-Fite submitted the study protocol, which has been approved by the IRB. Patient enrollment and dosing will begin immediately.
The pilot trial is a randomized, open-label, 2-arm study of Piclidenoson plus standard supportive care, compared to standard supportive care alone, in 40 hospitalized COVID-19 infected patients with moderate-to-severe symptomatic disease. Patients will be randomized in a 1:1 ratio to one of the trial arms and treated for up to 4 weeks. Key efficacy measures include time to resolution of viral shedding, time to resolution of clinical symptoms, measures of respiratory function, need for ventilatory support, and overall mortality. Standard safety parameters will also be measured. Dr. Dror Diker, M.D., Head of Internal Medicine D at the Rabin Medical Center, is the Principal Investigator of the study.
“Piclidenoson’s anti-viral, anti-inflammatory, and anti-rheumatic properties combined with its excellent safety profile make it a strong candidate for the potential treatment of coronavirus,” stated Can-Fite CEO Dr. Pnina Fishman. “We are very pleased to work with Dr. Diker and are grateful for the rapid response of Rabin Medical Center’s IRB, enabling us to treat patients without delay.”
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. Piclidenoson is currently under development for the treatment of autoimmune inflammatory diseases, and for the treatment of COVID-19. It is being evaluated in multinational Phase III studies as a first line treatment to replace methotrexate in the treatment of rheumatoid arthritis, and as a treatment for moderate-to-severe psoriasis. Piclidenoson has been approved for a pilot clinical trial in Israel to treat hospitalized COVID-19 infected patients with moderate-to-severe symptoms.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and COVID-19. The Company’s lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Piclidenoson has been approved for a pilot clinical trial in Israel to treat COVID-19 infected patients with moderate-to-severe symptoms. Can-Fite’s liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.
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