FDA Grants Orphan Drug Designation to Can-Fite's Namodenoson for Pancreatic Cancer

FDA Grants Orphan Drug Designation to Can-Fite's

Namodenoson for Pancreatic Cancer

RAMAT GAN, Israel, Oct. 09, 2024 (GLOBE NEWSWIRE) -- 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 announced the Company's oncology drug candidate, Namodenoson, has been granted Orphan

Drug Designation by the U.S. Food and Drug Administration (FDA) for the indication of pancreatic cancer, one of the most aggressive malignancies.

The designation as an orphan drug will provide among others, potential for market exclusivity for seven years after approval and several

and regulatory advantages (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions)

Can-Fite is now completing all the preparatory work for a Phase II

study in patients with pancreatic cancer. The study will be a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma

whose disease has progressed on at least 1st-line therapy. The trial will evaluate the safety, clinical activity, and pharmacokinetics

(PK) of Namodenoson in this patient population. All patients will receive oral Namodenoson 25 mg, administered twice daily for consecutive

28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective

of this trial is to characterize the safety profile of Namodenoson, and the secondary objective is to evaluate the clinical activity as

determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival

(PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

"We are advancing our plans to start our

Phase 2 study in pancreatic cancer and aim to commence the study by the end of year; we are thrilled that the FDA has granted Orphan Drug

Status," stated Can-Fite CEO Motti Farbstein".

Namodenoson is a small orally bioavailable drug

that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR), on the surface of liver and pancreatic cancer cells.

Namodenoson, induces apoptosis of these cancer cell types. Namodenoson was evaluated in Phase II liver cancer 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. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb

trial for the treatment of NASH a Phase III 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.canfite.com.

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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

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