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Thursday, April 22, 2021 8:10:03 AM
https://finance.yahoo.com/news/fite-expands-phase-ii-covid-112000890.html
Thu, April 22, 2021, 2:20 PM
The Phase II Study is under FDA Protocol and data are expected Q4 2021
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 the expansion of its Phase II COVID-19 study of Piclidenoson to two European countries, Romania and Bulgaria.
The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment of Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in patients hospitalized with moderate to severe COVID-19, as defined by the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Patients are randomized in a 1:1 ratio to receive 2 mg Piclidenoson twice daily or placebo, and treated for up to 28 days. Efficacy will be assessed through standard measures of clinical and respiratory status at Day 29, including the proportion of patients alive and free of respiratory failure, as well as the proportion discharged home without need for supplemental oxygen. Safety and pharmacokinetic data will also be captured.
Piclidenoson’s robust anti-inflammatory effect has the potential to treat COVID-19 and its mutations because it treats disease manifestations. The drug has anti-inflammatory effects proven in Phase II psoriasis clinical studies and in an interim analysis of an ongoing Phase III psoriasis study. The drug’s anti-viral properties are protected by U.S. patent US7589075. Piclidenoson also inhibits cytokine release syndrome which is associated with the severity of COVID-19.
"We are making efforts to continue and test the effect of Piclidenoson on patients with COVID-19 since we believe that the robust anti-inflammatory effect of the drug together with its excellent safety profile may improve outcomes and we look forward to seeing its impact following 28 days of treatment. With the reduction in COVID-19 cases in Israel, we believe expansion into Europe will help speed up recruitment " stated Can-Fite CEO Dr. Pnina Fishman.
About Piclidenoson
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. It is currently being evaluated in a multinational Phase III study as a treatment for moderate to severe psoriasis and a Phase II U.S. study for the treatment of moderate to severe COVID-19.
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, liver, inflammatory disease and COVID-19. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. 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.
Recent CANF News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/09/2024 11:03:03 AM
- Can-Fite: FDA Grants IND Clearance for Namodenoson to Treat MASH Patients in a Phase IIb Study • Business Wire • 05/09/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/06/2024 11:11:47 AM
- Can-Fite Received Notice of Allowance from the European Patent Office for the Treatment of Erectile Dysfunction with CF602 • Business Wire • 05/06/2024 11:00:00 AM
- Long-term Complete Response to Can-Fite's Namodenoson in Patient with Advanced Liver Cancer: Article Published in a Leading Scientific Journal • Business Wire • 04/25/2024 11:00:00 AM
- Can-Fite: Scientific Article Published by KOL Presents Namodenoson as a Promising Drug Candidate to Treat Advanced Liver Cancer and MASH • Business Wire • 04/15/2024 11:00:00 AM
- Can-Fite: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients • Business Wire • 04/03/2024 11:00:00 AM
- Can-Fite Reports 2023 Financial Results and Clinical Update • Business Wire • 03/28/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 03/11/2024 11:27:14 AM
- Namodenoson Treatment for Pancreatic and Liver Cancer: Data will be Discussed in Out-licensing and Distribution Partnering Meetings at Bio Europe Conference • Business Wire • 03/11/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/28/2024 12:06:42 PM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/29/2024 12:05:47 PM
- Can-Fite: Top Scientific Journal Published Positive Data from the COMFORT-1 Phase III Psoriasis Study • Business Wire • 01/29/2024 12:00:00 PM
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- The Anti-Obesity Effect of Can-Fite’s Namodenoson: Molecular Mechanism of Action in Pre-clinical and Human Studies • Business Wire • 12/20/2023 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/18/2023 12:07:51 PM
- Can-Fite Received FDA Positive Response to Psoriasis Pediatric Plan • Business Wire • 12/18/2023 12:00:00 PM
- Form F-3 - Registration statement by foreign private issuers • Edgar (US Regulatory) • 12/12/2023 09:15:49 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/04/2023 12:05:03 PM
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