This is an open-label trial in patients with advanced pancreatic cancer. The trial will evaluate the safety, clinical activity, and pharmacokinetics of the study drug, namodenoson, in this group of patients.

Start Date15 Jul 2024

Sponsor / Collaborator

Can-Fite BioPharma Ltd.

NCT05201404 / RecruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis

This is a clinical trial in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 (CPB7) cirrhosis whose disease has progressed on at least 1st-line therapy. The trial will evaluate the efficacy and safety of namodenoson as compared to placebo.

Start Date15 Mar 2023

Sponsor / Collaborator

Can-Fite BioPharma Ltd.

NCT04697810 / RecruitingPhase 2

A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo liver biopsy.

Start Date10 Dec 2021

Sponsor / Collaborator

Can-Fite BioPharma Ltd.

100 Clinical Results associated with Namodenoson

100 Translational Medicine associated with Namodenoson

100 Patents (Medical) associated with Namodenoson

192

Literatures (Medical) associated with Namodenoson

01 Feb 2024·Purinergic signalling

Covalently Binding Adenosine A3 Receptor Agonist ICBM Irreversibly Reduces Voltage-Gated Ca2+ Currents in Dorsal Root Ganglion Neurons

Article

Author: Coppi, Elisabetta ; Pugliese, Anna Maria ; Jacobson, Kenneth A. ; Scortichini, Mirko ; Magni, Giada ; Cherchi, Federica ; Venturini, Martina

Abstract :

Interest has been focused in recent years on the analgesic effects exerted by adenosine and its receptors, A1, A2A, A2B, and A3 adenosine receptor (AR) subtypes, in different in vivo models of chronic pain. In particular, it was demonstrated that selective A3AR agonists reduced pro-nociceptive N-type Ca2+ channels in dorsal root ganglion (DRG) neurons isolated from rats and, by this mechanism, inhibit post inflammatory visceral hypersensitivity. In the present study, we investigate the effect of a previously reported irreversibly binding A3AR agonist, ICBM, on Ca2+ currents (ICa) in rat DRG neurons. Present data demonstrate that ICBM, an isothiocyanate derivative designed for covalent binding to the receptor, concentration-dependently inhibits ICa. This effect is irreversible, since it persists after drug removal, differently from the prototypical A3AR agonist, Cl-IB-MECA. ICBM pre-exposure inhibits the effect of a subsequent Cl-IB-MECA application. Thus, covalent A3AR agonists such as ICBM may represent an innovative, beneficial, and longer-lasting strategy to achieve efficacious chronic pain control versus commonly used, reversible, A3AR agonists. However, the possible limitations of this drug and other covalent drugs may be, for example, a characteristic adverse effect profile, suggesting that more pre-clinical studies are needed.

08 Sep 2023·ACS pharmacology & translational science

First Potent Macrocyclic A₃ Adenosine Receptor Agonists Reveal G-Protein and β-Arrestin2 Signaling Preferences.

Article

Author: Wan, Tina C ; Tosh, Dilip K ; Jacobson, Kenneth A ; Auchampach, John A ; Salmaso, Veronica ; Fisher, Courtney L ; Campbell, Ryan G ; Chen, Eric ; Gao, Zhan-Guo

(N)-Methanocarba adenosine derivatives (A₃ adenosine receptor (AR) agonists containing bicyclo[3.1.0]hexane replacing furanose) were chain-extended at N⁶ and C2 positions with terminal alkenes for ring closure. The resulting macrocycles of 17-20 atoms retained affinity, indicating a spatially proximal orientation of these receptor-bound chains, consistent with molecular modeling of 12. C2-Arylethynyl-linked macrocycle 19 was more A₃AR-selective than 2-ether-linked macrocycle 12 (both 5'-methylamides, human (h) A₃AR affinities (K_i): 22.1 and 25.8 nM, respectively), with lower mouse A₃AR affinities. Functional hA₃AR comparison of two sets of open/closed analogues in β-arrestin2 and G_i/o protein assays showed certain signaling preferences divergent from reference agonist Cl-IB-MECA 1. The potencies of 1 at all three Gα_i isoforms were slightly less than its hA₃AR binding affinity (K_i: 1.4 nM), while the Gα_i1 and Gα_i2 potencies of macrocycle 12 were roughly an order of magnitude higher than its radioligand binding affinity. Gα_i2-coupling was enhanced in macrocycle 12 (EC₅₀ 2.56 nM, ∼40% greater maximal efficacy than 1). Di-O-allyl precursor 18 cyclized to form 19, increasing the Gα_i1 potency by 7.5-fold. The macrocycles 12 and 19 and their open precursors 11 and 18 potently stimulated β-arrestin2 recruitment, with EC₅₀ values (nM) of 5.17, 4.36, 1.30, and 4.35, respectively, and with nearly 50% greater efficacy compared to 1. This example of macrocyclization altering the coupling pathways of small-molecule (nonpeptide) GPCR agonists is the first for potent and selective macrocyclic AR agonists. These initial macrocyclic derivatives can serve as a guide for the future design of macrocyclic AR agonists displaying unanticipated pharmacology.

05 Sep 2023·Cells

Differential Gene Expression in Activated Microglia Treated with Adenosine A_2A Receptor Antagonists Highlights Olfactory Receptor 56 and T-Cell Activation GTPase-Activating Protein 1 as Potential Biomarkers of the Polarization of Activated Microglia.

Article

Author: Navarro, Gemma ; Franco, Rafael ; Lillo, Alejandro ; Lillo, Jaume ; Raïch, Iu ; Serrano-Marín, Joan

Microglial activation often accompanies the plastic changes occurring in the brain of patients with neurodegenerative diseases. A_2A and A₃ adenosine receptors have been proposed as therapeutic targets to combat neurodegeneration. RNAseq was performed using samples isolated from lipopolysaccharide/interferon-γ activated microglia treated with SCH 58261, a selective A_2A receptor antagonist, and with both SCH 58261 and 2-Cl-IB-MECA, a selective A₃ receptor agonist. None of the treatments led to any clear microglial phenotype when gene expression for classical biomarkers of microglial polarization was assessed. However, many of the downregulated genes were directly or indirectly related to immune system-related events. Searching for genes whose expression was both significantly and synergistically affected when treated with the two adenosine receptor ligands, the AC122413.1 and Olfr56 were selected among those that were, respectively, upregulated and downregulated. We therefore propose that the products of these genes, olfactory receptor 56 and T-cell activation GTPase-activating protein 1, deserve attention as potential biomarkers of phenotypes that occur upon microglial activation.

News (Medical) associated with Namodenoson

10 Jun 2024

·www.biospace.com

Can-Fite Received IRB Approval for the Treatment of Pancreatic Cancer with Namodenoson in a Phase IIa Study

Namodenoson showed efficacy in pre-clinical models via a definitive molecular mechanism of action 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 announced that it received an approval from the Institutional Review Board (IRB) of Rabin Medical Center, a leading medical institution in Israel where the study will be conducted. The approved protocol has been submitted now to the Ministry of Health (MOH). “This Phase IIa study is designed as an open-label one, enabling us to assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has progressed despite first-line treatment. Our positive Namodenoson data in pancreatic carcinoma experimental models together with the positive data in the Phase II advanced liver cancer study, with a patient showing overall survival of >7 years, encouraged us to initiate the current Phase IIa study,” stated Can-Fite’s Medical Director Dr. Michael Silverman. The protocol of the clinical study is CF102-222PC entitled: “A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma,” ClinicalTrials.gov Identifier: NCT06387342. The study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this 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 pro 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). The study will be conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel. Namodenoson recently received peer-reviewed recognition for its efficacy findings in pancreatic cancer including from the American Association of Cancer Research (AACR) which accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/β-catenin Signaling Pathway" for a poster presentation at the AACR Special Conference on Pancreatic Cancer, and from Biomolecules, a scientific journal focused on the function and mechanism of bioactive molecules, which published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/β-catenin, NF-κB, and RAS Signaling Pathways." 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 pro 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 Metabolic Dysfunction-associated Steatohepatitis (MASH), 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 pro experience in over 1,600 patients in clinical studies to date. For more information please visit: . 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: Contacts Can-Fite BioPharma Motti Farbstein info@canfite.com +972-3-9241114 Source: Can-Fite BioPharma Ltd. View this news release online at:

Phase 2Clinical ResultOrphan DrugFast Track

05 Jun 2024

·www.biospace.com

Can-Fite Updates on its Advanced Liver Cancer Pivotal Phase 3 Study

Namodenoson granted Orphan Drug and Fast track status from the FDA RAMAT GAN, 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 announced an update on the status of its oncological lead drug candidate, Namodenoson in the treatment of advanced liver cancer. The Phase 3 pivotal study now has 31 recruiting medical centers in Europe, Israel and the US. Namodenoson has Orphan Drug status with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency, as well as Fast Track Status with the FDA. A compassionate use program has also been ongoing in Israel and Romania. In the former Phase 2 study, conducted in patients with advanced liver cancer, Namodenoson prolonged survival, patients had good quality of life, and in two patients, clearance of peritoneal carcinomas have been reported. In addition, one patient had a long term complete response of more than 7 years. Liver cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. The market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries. The current double blind, placebo-controlled trial, known as LIVERATION, will enroll 450 patients diagnosed with advanced liver cancer (hepato-cellular carcinoma) and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will be randomized to oral treatment with either 25 mg of Namodenoson or a matching placebo, in a ratio of 2:1 given twice daily as a second- or third-line treatment. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. 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 pro 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 Metabolic Dysfunction-associated Steatohepatitis (MASH), 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 pro experience in over 1,600 patients in clinical studies to date. For more information please visit: . 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.

Phase 2Clinical ResultOrphan DrugFast TrackPhase 3

29 May 2024

·www.biospace.com

Independent Scientists Published a Review Article Demonstrating That Can-Fite Drugs Have Therapeutic Effects on Heart Diseases

RAMAT-GAN, 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 reported that the International Journal of Molecular Sciences published a scientific review by independent scientists summarizing >50 publications from scientists all over the world stating that piclidenoson and namodenoson have a positive effect on heart diseases (Link to article). According to the review, both piclidenoson and namodenoson induced in pre-clinical in vivo studies beneficial outcomes in cardiac ischemia, protection against ischemic/reperfusion injury, reduction in infarct size, improved contractile function against ischemic preconditioning, attenuation of cardiac hypertrophy, fibrosis, and myocardial dysfunction and more. Can-Fite CSO & Executive Chairperson, Dr. Pnina Fishman commented on these findings, stating, "It is very interesting that our drug candidates have additional well-defined cardio-protective effect and have the potential to positively influence a broad range of heart diseases. In fact, we believe now that this is part of the mechanism contributing to the very good safety pro has been observed all along the clinical development in more than 1600 patients suffering from psoriasis, liver cancer and MASH”. Can-Fite continues with its efforts to commence a Phase 3 clinical study in psoriasis, continues to enroll patients in a Phase 3 clinical study in advanced liver cancer as well asa Phase 2b study in MASH while additionally planning to start enrolment for a Phase 2a clinical study in pancreatic cancer in the near term. 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 Metabolic Dysfunction-associated Steatohepatitis (MASH), 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 pro experience in over 1,600 patients in clinical studies to date. For more information please visit: . 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: Contacts Can-Fite BioPharma Motti Farbstein info@canfite.com +972-3-9241114 Source: Can-Fite BioPharma Ltd. View this news release online at:

Phase 2Phase 3Fast TrackOrphan DrugClinical Result

100 Deals associated with Namodenoson

External Link

KEGG	Wiki	ATC	Drug Bank
D11128	-	-	DB12885

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Hepatocellular Carcinoma	Phase 3	US	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	BA	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	BG	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	IL	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	MD	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	PL	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	RO	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	RS	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	SK	Can-Fite BioPharma Ltd.	15 Mar 2023
Fibrosis	Phase 3	US	Can-Fite BioPharma Ltd.	15 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02128958 (ILCA2022)	Phase 2	Advanced Hepatocellular Carcinoma	-	Namodenoson	sgnavypout(moujldivhu) = ztdzfoqymp jtfnrntwji (qlgwacsdgg ) View more	Positive	02 Sep 2022
				Placebo	sgnavypout(moujldivhu) = yqtxmbfvah jtfnrntwji (qlgwacsdgg )
NCT02128958 (CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	78	CF102 (CF102)	junhfxiwii(ybaeatqjbe) = vxauwajqqd gcmtahgbhi (sqebxkymby, gepynzemvt - imwthfebwm) View more	-	29 Dec 2021
				Placebo (Placebo Tablets of CF102)	junhfxiwii(ybaeatqjbe) = mcnvuvwbuw gcmtahgbhi (sqebxkymby, yzzqwfkwbh - vjhdoissti) View more
NCT02927314 (Pubmed \| Aliment Pharmacol Ther)	Phase 2	Fatty Liver \| Metabolic dysfunction-associated steatotic liver disease	60	Namodenoson 25 mg b.d.	chnmyqzznq(skrrzrxoed) = letldtifrq zjzwtcsaza (lrxxjbtcrv )	-	20 Oct 2021
				Placebo	chnmyqzznq(skrrzrxoed) = fhjvfvvttq zjzwtcsaza (lrxxjbtcrv )
NCT02128958 (Pubmed) Manual	Phase 2	Fibrosis \| Advanced Hepatocellular Carcinoma Second line	78	Namodenoson	yjrnbxqupz(gtnmevnxqk) = wkfkvygsfc yichmsrfuf (yvvcffseuf ) View more	Positive	07 Jan 2021
				Placebo	yjrnbxqupz(gtnmevnxqk) = plbaqooaht yichmsrfuf (yvvcffseuf ) View more
NCT02128958 (ASCO2019) Manual	Phase 2	Advanced Hepatocellular Carcinoma Second line	78	Namodenoson 25 mg	hfnjtdcqts(rsjclvctag) = lbgmhxzapa llrlgpszdx (upagosnrhm )	Positive	02 Jun 2019
				placebo	hfnjtdcqts(rsjclvctag) = ywoumctmza llrlgpszdx (upagosnrhm )
NCT00790673 (CTgov)	Phase 1/2	Chronic hepatitis C genotype 1	32	CF102 (Cohort 1 CF102 1 mg qd)	wgahsodfes(xsmmeorewd) = hqqispsqyo bqhpgyrgkk (pfnwdikwte, kpylewgppb - wivwmdjrqa) View more	-	15 Apr 2015
				CF102 (Cohort 2 CF102 1 mg Bid)	wgahsodfes(xsmmeorewd) = axtmelrlwi bqhpgyrgkk (pfnwdikwte, quefznchef - okrlqiqufb) View more
NCT00790218 (CTgov)	Phase 1/2	Advanced Hepatocellular Carcinoma	19	CF102 (CF102 1mg)	aohwqgiuly(nfkrimynui) = koqzvnbmxd vqxgitgxma (rpxsgikbwo, nnscvhxhko - ljemoacfld) View more	-	27 Feb 2015
				CF102 (CF102 5mg)	aohwqgiuly(nfkrimynui) = nvzkirqvou vqxgitgxma (rpxsgikbwo, wnsqudeccy - dimtuiwvnf) View more
NCT00790218 (Pubmed \| Oncologist)	Phase 1/2	Hepatocellular Carcinoma	19	CF102 1 mg BID	dfcbrjczcg(glbqddubdq) = xdtsewtmvs edzszjyeaf (eswxwyyfup )	-	01 Jan 2013
				CF102 5 mg BID	dfcbrjczcg(glbqddubdq) = lzazbxpgcm edzszjyeaf (eswxwyyfup )

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