Israeli drug developer Can Fite BioPharma Ltd. (NYSE: CANF; TASE:CFBI) 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. Piclidenoson is currently under development for the treatment of autoimmune inflammatory diseases.
Can-Fite CEO Dr. Pnina Fishman said, "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. 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."
On March 23, 2020, Can-Fite announced it had 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.
Can-Fite's share price rose 51.93% today on the TASE to NIS 27.50.
Published by Globes, Israel business news - www.globes-online.com - on April 13, 2020
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