Thursday, May 21, 2020 7:18:53 AM
7:03 am ET May 21, 2020 (Benzinga) Print
Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced the U.S. Patent and Trademark Office (PTO) has issued a Notice of Allowance for the Company’s patent titled, “Method for treating NASH accompanied by fibrosis using CI-IB-MECA”. The allowance follows Can-Fite’s recent announcement of highly encouraging data from its Phase II study of its drug candidate Namodenoson, generically known as CI-IB-MECA, in the treatment of non-alcoholic fatty liver disease (NAFLD) with or without non-alcoholic steatohepatitis (NASH).
The allowed patent covers the use of the A3 adenosine receptor (A3AR) in reducing ectopic fat accumulation, particularly in fatty liver. The patent specifically addresses preparation of a pharmaceutical composition for reducing fat accumulation and a method of treating conditions associated with fat accumulation such as fatty liver diseases including NASH and NAFLD.
Can-Fite recently announced findings from its Phase II study of Namodenoson in the treatment of patients with NAFLD with or without NASH. The study achieved its efficacy endpoints in a dose dependent and statistically significant manner, while continuing to demonstrate a good safety profile. The Phase II data revealed that the 25 mg dose of Namodenoson resolved significantly all cases of NASH, representing 25% of the 25 mg treated group, as compared to an increase in new NASH cases in the placebo group from a baseline of 0 to 5.9%. Namodenoson dosed at 25 mg reduced hepatic fibrosis (scar tissue in the liver resulting from the liver trying to repair itself), reduced steatosis (fat buildup in the liver), and improved the FAST score, a measure for NASH (liver stiffness and an enzymatic biomarker of liver damage).
“We are very pleased to receive this Notice of Allowance from the U.S. PTO at this time, immediately following an analysis of Phase II data that show Namodenoson is highly effective in treating and reversing fatty liver. At the optimal 25 mg dosage, Namodenoson eliminated NASH in the Phase II patient population. The protection provided by the allowed patent has a high value for us, as we move forward into advanced stage clinical trials in this indication, and as we evaluate distribution partnerships for Namodenoson,” stated Can-Fite CEO, Dr. Pnina Fishman.
An estimated 85 million Americans have NAFLD, which may lead to an exponential rise in incidence of NASH, a more severe form of NAFLD, to close to 43 million Americans in the next five years. The NASH treatment market is estimated to reach $35-40 billion by 2025.
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
VPR Brands LP Reports Record Annual Financial Performance for Fiscal Year 2023 • VPRB • Apr 19, 2024 11:24 AM
Coinllectibles' Subsidiary, Grand Town Development Limited, Acquires Rare Song Dynasty Ceramics Worth Over USD28million • COSG • Apr 18, 2024 8:03 AM
ILUS Provides Form 10-K Filing Update • ILUS • Apr 17, 2024 9:54 AM
Glucotrack Announces Expansion of Its Continuous Glucose Monitoring Technology to Epidural Glucose Monitoring • GCTK • Apr 17, 2024 8:00 AM
Maybacks Global Entertainment To Fire Up 24 New Stations in Louisiana • AHRO • Apr 16, 2024 1:30 PM
Cannabix Technologies Begins Certification of Contactless Alcohol Breathalyzer, Re-Brands product series to Breath Logix • BLOZF • Apr 16, 2024 8:52 AM