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Can-Fite obesity drug namodenoson receives patent

Namodenoson is an oral medication with a proven favorable safety profile

RAMAT GAN, Israel, Nov. 4, 2024 (GLOBE NEWSWIRE) — Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs to treat oncology and inflammatory diseases, today provided an update on the intellectual property (IP) status of its lead drug candidate, namodenoson. is currently being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), advanced liver cancer and pancreatic cancer. In all clinical studies conducted, namodenoson demonstrated a very favorable safety profile when administered orally.

Patent application number 2020205042 entitled “An A3 adenosine receptor ligand for use in achieving a fat loss effect” has been accepted by the Australian Patent Office and expires in 2040.

The patent application covers methods for treating obese patients by administering namodenoson in an oral formulation. Can-Fite already has several approved patents and corresponding applications in various territories around the world, including Europe and the USA, for the drug's various clinical applications.

The anti-obesity patent application is based on data showing that treating fat cells with namodenoson reduces fat content by increasing the hormone adiponectin, a regulator of fat production in the body. Namodenoson also reduced body weight in an experimental animal model of obesity induced by a high-fat diet. In a Phase IIa study of MASH patients treated with namodenoson, a 2.3% weight loss was observed at 3 months with a significant increase in serum adiponectin levels.

“We are pleased that namodenoson’s obesity product protection has been accepted in Australia and is valid until 2040. Namodenoson is currently being developed in a Phase IIb trial for the treatment of MASH, where most patients are obese. “We look forward to seeing the anti-obesity effect in this clinical trial,” said Pnina Fishman, Ph.D. , CSO and Chairman of Can-Fite.

The global obesity treatment market is lucrative due to awareness of a link between chronic diseases and obesity and was valued at $12 billion in 2023, according to Market Research Future. There are expected to be around 1.85 million MASH patients in Australia alone

About namodenoson

Namodenoson is a small, orally bioavailable drug that binds to the A3 adenosine receptor (A3AR) with high affinity and selectivity. Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer and a Phase IIb trial for the treatment of steatotic liver disease (SLD). The company is also planning a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells, whereas low expression is found in normal cells. This differential expression could be one of the important factors responsible for the excellent safety profile of the drug.

About namodenoson

Namodenoson is a small, orally bioavailable drug that binds to the A3 adenosine receptor (A3AR) with high affinity and selectivity. Namodenoson was studied in Phase II trials for two indications: as a second-line treatment for hepatocellular carcinoma and as a treatment for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells, whereas low expression is found in normal cells. This different effect explains the drug's excellent safety profile.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development company with platform technology targeting multi-billion dollar markets in the treatment of cancer, liver and inflammatory diseases. The company's lead drug candidate, piclidenoson, recently reported topline results from a Phase III trial for the treatment of psoriasis. Can-Fite's liver drug, namodenoson, is being evaluated in a Phase IIb trial for the treatment of MASH, a Phase III trial for hepatocellular carcinoma (HCC), and the company plans a Phase IIa trial for pancreatic cancer. Namodenoson has received orphan drug designation in the United States and Europe and fast-track designation from the United States Food and Drug Administration as a second-line treatment for HCC. Namodenoson has also demonstrated proof of concept for the potential treatment of other cancers such as colon, prostate and melanoma. CF602, the company's third drug candidate, has been shown to be effective in treating erectile dysfunction. These medications have an excellent safety profile and have been tested in clinical trials on over 1,600 patients to date. Further information can be found at: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements about Can-Fite's expectations, beliefs or intentions with respect to, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this release, other than those relating to historical facts, are “forward-looking statements.” Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “could”, “should” or “anticipate” or the negative thereof or other variations of these words or other comparable words or due to the fact that these statements do not relate exclusively to historical or current matters. Forward-looking statements address anticipated or anticipated events, activities, trends or results as of the date they are made. Because forward-looking statements address matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite's actual results, performance or achievements to differ materially from future results . Achievements or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among others, our history of losses and the need for additional capital to fund our operations and our inability to raise additional capital procure acceptable conditions or at all; uncertainties regarding cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other efforts to develop product candidates; our ability to advance our product candidates into clinical trials or successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the level of intellectual property protection we can establish and maintain for our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to a resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks associated with failure to comply with NYSE American's continued listing requirements; and statements about the impact of the political and security situation in Israel on our business. Further information regarding these risks, uncertainties and other factors can be found from time to time in the “Risk Factors” section of Can-Fite's Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports , filed with the SEC and in its periodic filings with the TASE. Existing and potential investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date made. Can-Fite undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by applicable securities laws.

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Can-Fite BioPharma

Motti Farbstein

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