After complete elimination of cancerous lesions in patients with advanced liver cancer, Can-Fite files patent applications for the treatment of various advanced solid tumors


Namodenoson Heads For Pivotal Phase III Liver Cancer Study

PETACH TIKVA, Israel, December 29, 2021– (BUSINESS WIRE) – Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company developing a pipeline of proprietary small molecule drugs that treat inflammatory, cancer and liver diseases, today announced the company is filing new patent applications in several countries for the treatment of all advanced solid tumors based on new clinical data showing that a patient with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer, has been cleared of all tumor lesions after treatment with Namodenoson, an adenosine A3 receptor (A3AR) ligand. These pending patent applications are the latest in Can-Fite’s growing intellectual property portfolio spanning its platform technology, as well as its drug candidate Namodenoson and its use in a variety of advanced cancers.

Can-Fite’s Namodenoson, a small, orally bioavailable drug that binds with high affinity and selectivity to A3AR, has recently been shown to be effective in clearing all cancerous lesions in a patient treated for an open label extension program of its completed phase II study for the treatment of HCC. In the first quarter of 2022, Can-Fite plans to begin patient enrollment in its pivotal Phase III trial for Namodenoson in the treatment of patients with advanced HCC with underlying Child Pugh B7 cirrhosis (CPB7 ) to support a New Drug Application (NDA) submission and approval.

“Can-Fite’s intellectual property portfolio includes approximately 200 patents and pending patent applications in 16 patent families. Given the very strong new data on the efficacy of Namodenoson in advanced HCC, these latest patent filings aim to further strengthen our intellectual property position regarding Namodenoson in liver cancer and also expand our pending claims for advanced diseases. in other cancer indications, ”said Can-Fite President Dr. Ilan Cohn, Senior Partner and Founder of Cohn De Vries Stadler & Co., a leading intellectual property company.

About Namodenoson

Namodenoson is a small, orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson has been 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 while low expression is found in normal cells. This differential effect explains 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 drug development company with a technology platform designed to address multi-billion dollar markets in the treatment of cancer, liver and inflammatory diseases . The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis. Can-Fite’s liver drug Namodenoson is heading into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of steatohepatitis non-alcoholic (NASH). Namodenoson has received orphan drug designation in the United States and Europe and expedited designation as a second-line treatment for HCC by the United States 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 been shown to be effective 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 regarding Can-Fite’s expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, its business, its financial condition, its results. operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, either orally or in writing. Forward-looking statements may 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 or other comparable words or that such statements do not relate strictly to historical or current matters. These forward-looking statements may be included, without limitation, in various documents filed by Can-Fite with the United States Securities and Exchange Commission, press releases or oral statements made by or with the approval of the one of Can-Fite’s authorized officers. officers. Forward-looking statements relate to events, activities, trends or results anticipated or expected on the date they are made. Since forward-looking statements relate to events which have not yet occurred, such statements are inherently subject to risks and uncertainties which could cause Can-Fite’s actual results to differ materially from future results expressed. or implied by forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in these forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in these forward-looking statements include, but are not limited to: our history of losses and our need for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or not at all; uncertainties over cash flow and inability to meet working capital requirements; 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 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; implementing our business model and strategic plans for our business and product candidates; the extent of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to conduct our business without infringing the intellectual property rights of others; competitive businesses, technologies and our industry; statements on the impact of the political and security situation in Israel on our activities; and the 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 industrial sector where the values ​​of securities are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite assumes no obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

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Contacts

Can-Fite BioPharma
Motti Farbstein
[email protected]
+ 972-3-9241114


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