Followers | 145 |
Posts | 27556 |
Boards Moderated | 3 |
Alias Born | 02/07/2004 |
Friday, January 08, 2021 7:56:24 AM
https://finance.yahoo.com/news/fite-announces-publication-namodenoson-liver-120000054.html
Fri, January 8, 2021, 2:00 PM GMT+2
Significant 12-month overall survival benefit in the CPB7 population and 2 patients are still under treatment for more than 3.5 years
Namodenoson is headed into a global pivotal Phase III study
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 a scientific paper titled, "Namodenoson in Advanced Hepatocellular Carcinoma and Child–Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial" was published in the peer reviewed journal Cancers.
The paper highlights and analyzes results from Can-Fite’s Phase II study, a randomized placebo-controlled trial to investigate Namodenoson as a 2nd-line treatment for advanced hepatocellular carcinoma (HCC) and moderate hepatic dysfunction, as defined by Child–Pugh B (CPB) scores of 7–9. Even though the trial did not meet its primary endpoint, in patients with a CPB score of 7, Namodenoson was associated with a significant improvement in 12-month overall survival and 2 patients are still under treatment for more than 3.5 years.
A pivotal Phase III study of Namodenoson as a 2nd or 3rd line treatment in HCC CPB7 patients has been designed, and both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed with the protocol. Upon successful results, the trial may lead to concurrent marketing approval in the U.S. and Europe. Namodenoson has been granted Orphan Drug Status by both the FDA and EMA, in addition to Fast Track Status by the FDA. Namodenoson continues to be administered to HCC patients under a compassionate use program in Israel.
"With the publication of this study, we believe we are advancing the body of scientific data needed to bring a treatment to HCC patients with Child-Pugh B7. This subset of patients with advanced disease and borderline liver function have few, if any treatment options. Nearly all other liver cancer studies exclude these patients due to poor prognosis. As detailed in our published paper, Namodenoson significantly prolonged 12-month survival in HCC CPB7 patients in our Phase II study. We are hopeful that if our planned pivotal study produces similar results, Can-Fite will be able to offer a much needed therapy to this population of advanced liver cancer patients," stated Can-Fite CEO Dr. Pnina Fishman.
Liver cancer is one of the leading causes of cancer deaths globally, with an estimated 854,000 new cases and 810,000 deaths annually. DelveInsight estimates the HCC drug market will reach $3.8 billion in 2027 in the G8 countries.
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
- 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
- Can-Fite Broadens its Strong Intellectual Property (IP) for NASH: Received Patent Allowance in Canada • Business Wire • 02/28/2024 12:00:00 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 08:32:17 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/30/2024 12:24:02 PM
- Can-Fite Expands the Out-Licensing Deal with Ewopharma to Include the Pancreatic Cancer Indication • Business Wire • 01/30/2024 12:00:00 PM
- 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
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 01/08/2024 05:15:13 AM
- Form F-3/A - Registration statement by foreign private issuers: [Amend] • Edgar (US Regulatory) • 12/28/2023 09:16:08 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/20/2023 12:09:12 PM
- 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
- Can-Fite’s Namodenoson for the Treatment of Pancreatic Cancer Patients: Progress in Clinical Development • Business Wire • 12/04/2023 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/30/2023 12:05:42 PM
- Can-Fite Reports Third Quarter 2023 Financial Results and Clinical Update • Business Wire • 11/30/2023 12:00:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 11/22/2023 09:20:47 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/22/2023 09:15:30 PM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM
BestGrowthStocks.com Issues Comprehensive Analysis of Triller Merger with AGBA Group Holding Limited • AGBA • Apr 22, 2024 1:00 PM
Cannabix Technologies to Present Marijuana Breathalyzer Technology at International Association for Chemical Testing (IACT) Conference in California • BLO • Apr 22, 2024 8:49 AM