Can-Fite’s CEO to Present Namodenoson’s Efficacy in Liver Cancer as Expert Speaker at the Adenosine Pathway Targeted Cancer Immunotherapy Summit

Rhea-AI Summary

Can-Fite BioPharma (NYSE American: CANF) announced a Phase II study where Namodenoson, an oral drug targeting liver cancer, cleared all lesions in an advanced patient. The pivotal Phase III trial has received FDA and EMA approval and is now open to recruit around 450 hepatocellular carcinoma patients. The drug selectively binds to the A3 adenosine receptor, prevalent in cancer cells. CEO Dr. Pnina Fishman is set to present at the Adenosine Pathway Targeted Cancer Immunotherapy Summit in Boston on May 12, 2022, highlighting the drug's promising results.

• Namodenoson induced complete response and cleared all cancer lesions in advanced liver cancer patient in Phase II study
• Pivotal Phase III trial for the treatment of liver cancer is now open for the recruitment of patients

PETACH TIKVA, Israel--(BUSINESS WIRE)-- 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 the Company’s CEO Dr. Pnina Fishman has been invited as an expert speaker to deliver a presentation titled “Targeting the A3 Adenosine Receptor for the Treatment of Advanced Liver Cancer” at the Adenosine Pathway Targeted Cancer Immunotherapy Summit in Boston on May 12, 2022.

Radiological data show the disappearance of tumor lesions from a patient treated with Namodenoson who had advanced disease and fully recovered. (Graphic: Business Wire)

Namodenoson, a small orally bioavailable drug that specifically binds to the A3 adenosine receptor (A3AR), over-expressed in liver cancer but not normal cells, is headed into a Phase III liver cancer pivotal trial. The trial has received a green light from both the U.S. FDA and the European Medicines Agency (EMA) and is now open for the recruitment of approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies. A prior Phase II HCC study patient who continues to be treated with Namodenoson has survived more than five years and cleared all cancer lesions.

“Adenosine pathway targets have become one of the most clinically validated oncology pathways, further validating our A3AR target for the treatment of liver and other cancers. I’m pleased to be invited to speak and share Can-Fite’s experience with adenosine pathway drug development and clinical trials, and radiological data showing the disappearance of tumor lesions from a patient treated with Namodenoson who had advanced disease and fully recovered,” stated Can-Fite CEO Dr. Pnina Fishman.

The inaugural Adenosine Pathway Targeted Cancer Immunotherapy Summit is dedicated to optimizing the efficacy of adenosine pathway targeted drugs, overcoming challenges of resistance and immunosuppression, and supercharging therapeutics into the clinic. The conference aims to maximize the clinical and commercial opportunity of the adenosine pathway as a second-generation immuno-oncology target.

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: CFBI) 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 has completed enrollment in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 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, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. 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. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. 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 risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: 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 impact of the COVID-19 pandemic; 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; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220502005267/en/

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

Source: Can-Fite BioPharma Ltd.

FAQ

What were the results of the Phase II study for CANF's Namodenoson?

The Phase II study of Namodenoson showed a complete response, clearing all cancer lesions in an advanced liver cancer patient.

Is there a Phase III trial for CANF's Namodenoson?

Yes, a pivotal Phase III trial for Namodenoson is now open for patient recruitment, targeting approximately 450 individuals with hepatocellular carcinoma.

What is the significance of Dr. Pnina Fishman’s presentation on May 12, 2022?

Dr. Pnina Fishman will present on the targeting of the A3 Adenosine Receptor for advanced liver cancer at the Adenosine Pathway Targeted Cancer Immunotherapy Summit in Boston.

What does Namodenoson target in liver cancer treatment?

Namodenoson specifically targets the A3 adenosine receptor, which is over-expressed in liver cancer cells.

How many patients were involved in the Phase III trial for CANF's liver cancer drug?

The Phase III trial aims to recruit approximately 450 patients diagnosed with hepatocellular carcinoma.