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Monday, February 22, 2021 7:47:03 AM
https://finance.yahoo.com/news/positive-data-fite-liver-cancer-121000609.html
February 22 2021 - 07:10AM
Overall survival of nearly 4 years in two patients with disappearance of ascites, normal liver function, and good quality of life
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced new data from the Phase II advanced liver cancer study including overall survival of nearly 4 years in two patients who are under namodenoson treatment. Additional findings show disappearance of ascites, normal liver function and good quality of life. In one patient stable disease has been recorded with disappearance of peritoneal carcinomatosis. Namodenoson continues to demonstrate a good safety profile and is well tolerated with no severe adverse events reported.
Recently, the Company successfully concluded End-of-Phase II meetings with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Both agencies agreed with Can-Fite’s proposed pivotal Phase III trial design of Namodenoson for the treatment of patients with advanced hepatocellular carcinoma (HCC), with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. The trial is expected to enroll 450 patients through multiple centers worldwide. Namodenoson has Orphan Drug Designation for HCC in the U.S. and Europe, has Fast Track Status in the U.S., and is currently treating liver cancer patients through a compassionate use program in Israel.
“We are very pleased to see prolonged survival, good quality of life, and in particular clearance of peritoneal carcinomas in these two patients. The FDA and EMA gave a green light to one pivotal Phase III study which, upon positive conclusion, would lead to registration of Namodenoson for the treatment of this devastating disease. To our knowledge, Can-Fite is the only company developing a drug for this advanced patient population defined as Child Pugh B7 (CPB7) cirrhosis,” stated Can-Fite CEO Dr. Pnina Fishman.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
Recent CANF News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/16/2024 11:07:52 AM
- Can-Fite: Pancreatic Carcinoma Phase IIa Clinical Study with Namodenoson Received Regulatory Authorization from the Israeli Ministry of Health • GlobeNewswire Inc. • 09/16/2024 11:00:00 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/09/2024 04:15:08 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 09/06/2024 08:30:17 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/30/2024 08:18:30 PM
- Form F-3 - Registration statement by foreign private issuers • Edgar (US Regulatory) • 08/30/2024 08:18:01 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 08/30/2024 08:16:15 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/30/2024 08:15:30 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/29/2024 12:46:20 PM
- Can-Fite Reports First Half 2024 Financial Results & Progress in Two Pivotal Phase III Clinical Studies • GlobeNewswire Inc. • 08/29/2024 12:15:57 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/12/2024 10:45:11 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/09/2024 10:07:53 AM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/29/2024 11:03:27 AM
- Can-Fite Provides Namodenoson Patent Update • GlobeNewswire Inc. • 07/29/2024 11:00:00 AM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/11/2024 11:05:26 AM
- Can-Fite Applies for FDA Orphan Drug Designation for Namodenoson in the Treatment of Pancreatic Cancer • GlobeNewswire Inc. • 07/11/2024 11:00:00 AM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 06/10/2024 11:05:22 AM
- Can-Fite Received IRB Approval for the Treatment of Pancreatic Cancer with Namodenoson in a Phase IIa Study • Business Wire • 06/10/2024 11:00:00 AM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 06/07/2024 08:15:12 PM
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