Can-Fite: Breakthrough Findings Demonstrate Namodenoson Anti-cancer and Protective Effect Mechanism in the Liver

Rhea-AI Summary

Can-Fite BioPharma (NYSE American: CANF) has announced breakthrough findings regarding Namodenoson, a drug demonstrating significant anti-cancer and protective effects in the liver. These effects are attributed to the signaling protein adiponectin, which has key roles in anti-inflammatory, anti-cancer, metabolic, and insulin resistance regulation. Namodenoson has been shown to increase adiponectin production in both pre-clinical studies and human trials. The data will be presented at the 20th Annual Congress of International Drug Discovery Science & Technology in China, from September 12-14, 2024. Namodenoson is currently being evaluated in a Phase III study for advanced liver cancer and a Phase IIb study for MASH.

Positive

• Breakthrough findings demonstrate Namodenoson's dual mechanism in anti-cancer and liver protection.
• Namodenoson increases adiponectin production, a positive cytokine with multiple health benefits.
• Ongoing Phase III and Phase IIb studies indicate advanced research and potential market readiness.
• FDA and EMA approval for ongoing Phase III study adds credibility to the research.

Negative

• The effectiveness of Namodenoson is still under evaluation and results are not yet conclusive.
• The drug is still in clinical trials, meaning it has not yet reached the market.

Oncology Doctor

Namodenoson, currently under a pivotal Phase III study for advanced liver cancer, shows promising data by enhancing adiponectin production. Adiponectin is important for its anti-inflammatory and anti-cancer properties, which are particularly beneficial in liver conditions. This advancement could lead to novel, effective treatments for liver cancer, a field that greatly needs innovation.

However, it's essential to note that these findings are pre-clinical and need validation through ongoing clinical trials. The multifunctional nature of adiponectin as an anti-cancer and liver-protective agent provides a dual benefit, potentially improving patient outcomes not only by suppressing cancer growth but also by protecting liver function during treatment.

Investors should monitor the progress of these trials closely. While the data is promising, the success in clinical settings will significantly impact the company's prospects. Positive clinical outcomes could position Namodenoson as a key player in liver cancer treatment, bringing substantial long-term value.

Financial Analyst

From a financial perspective, Can-Fite BioPharma has made a notable announcement that may influence investor sentiment. The breakthrough findings related to Namodenoson’s mechanism can boost confidence in the company's current valuation. If Namodenoson succeeds in its Phase III trials, it could result in strong revenue streams from the liver cancer market, which is significant given the unmet medical need.

However, investors must remain cautious and consider the inherent risks in biotech investments. The positive pre-clinical data is a step forward, but the market will closely watch the upcoming Phase III trial results. Successful results could lead to regulatory approvals and commercialization, substantially increasing Can-Fite's market cap and share price.

Short-term volatility is expected, but a successful trial could lead to significant long-term gains for investors.

PETACH TIKVA, Israel--(BUSINESS WIRE)-- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announces that company scientists came up with breakthrough findings showing that the anti-cancer and protective effects in the liver are conferred via the signalling protein adiponectin. This very important positive cytokine plays a pivotal role in regulating anti-inflammatory, anti-cancer, metabolic and insulin resistance. Namodenoson increases adiponectin production in pre-clinical studies and in humans.

The data will be presented at the 20th Annual Congress of International Drug Discovery Science & Technology, China Branch (IDDST-2024), September 12-14, Shanghai, China. This conference will host 300 leading scientists from the academia and industry worldwide to discuss the latest developments in drug discovery and therapy.

“We are very much enthused by the breakthrough findings that explain the dual mechanism of Namodenoson working as an anti-cancer agent in the liver and also inducing a liver protective effect,” stated Dr. Pnina Fishman, Can-Fite CSO & Chairperson.

Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and also in a Phase IIb study in patients with MASH.

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.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) 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, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite’s cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. 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 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, 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,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to 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 be materially different from any future results, performance 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 other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to 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 scope of protection we are able to establish and maintain for intellectual property rights covering 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 any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included 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 prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240624268136/en/

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

Source: Can-Fite BioPharma Ltd.

FAQ

What are the recent findings related to Namodenoson and its effects on the liver?

Recent findings show that Namodenoson exhibits significant anti-cancer and protective effects in the liver by increasing adiponectin production.

When and where will the Namodenoson data be presented?

The data will be presented at the 20th Annual Congress of International Drug Discovery Science & Technology in China, from September 12-14, 2024.

What is Namodenoson's mechanism of action in the liver?

Namodenoson works through the signaling protein adiponectin, which regulates anti-inflammatory, anti-cancer, metabolic, and insulin resistance processes.

What stage of clinical trials is Namodenoson currently in?

Namodenoson is in a pivotal Phase III study for advanced liver cancer and a Phase IIb study for MASH.

Has Namodenoson received any regulatory approval?

Yes, Namodenoson's Phase III study has been approved by both the U.S. FDA and the EMA.