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 Dec 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

202

Literatures (Medical) associated with Namodenoson

01 Oct 2024·Purinergic Signalling

Genetic and functional modulation by agonist MRS5698 and allosteric enhancer LUF6000 at the native A3 adenosine receptor in HL-60 cells

Article

Author: Gao, Zhan-Guo ; Jacobson, Kenneth A ; Hanover, John A ; Chen, Weiping ; Li, Jonathan ; Tosh, Dilip K ; Gao, Ray R

AbstractThe A3 adenosine receptor (AR) is an important inflammatory and immunological target. However, the underlying mechanisms are not fully understood. Here, we report the gene regulation in HL-60 cells treated acutely with highly selective A3AR agonist MRS5698, positive allosteric modulator (PAM) LUF6000, or both. Both pro- and anti-inflammatory genes, such as IL-1a, IL-1β, and NFκBIZ, are significantly upregulated. During our observations, LUF6000 alone produced a lesser effect, while the MRS5698 + LUF6000 group demonstrated generally greater effects than MRS5698 alone, consistent with allosteric enhancement. The number of genes up- and down-regulated are similar. Pathway analysis highlighted the critical involvement of signaling molecules, including IL-6 and IL-17. Important upstream regulators include IL-1a, IL-1β, TNF-α, NF-κB, etc. PPAR, which modulates eicosanoid metabolism, was highly downregulated by the A3AR agonist. Considering previous pharmacological results and mathematical modeling, LUF6000’s small enhancement of genetic upregulation suggested that MRS5698 is a nearly full agonist, which we demonstrated in both cAMP and calcium assays. The smaller effect of LUF6000 on MRS5698 in comparison to its effect on Cl-IB-MECA was shown in both HL-60 cells endogenously expressing the human (h) A3AR and in recombinant hA3AR-expressing CHO cells, consistent with its HL-60 cell genetic regulation patterns. In summary, by using both selective agonists and PAM, we identified genes that are closely relevant to immunity and inflammation to be regulated by A3AR in differentiated HL-60 cells, a cell model of neutrophil function. In addition, we demonstrated the previously uncharacterized allosteric signaling-enhancing effect of LUF6000 in cells endogenously expressing the hA3AR.

01 Sep 2024·Mitochondrion

Neuroprotective compounds alter the expression of genes coding for proteins related to mitochondrial function in activated microglia

Article

Author: Navarro, Gemma ; Luis Labandeira-García, José ; Quijano, Aloia ; Valenzuela, Rita ; Serrano-Marín, Joan ; Delgado, Cristina ; Franco, Rafael

A hallmark of neuroinflammatory disorders is mitochondrial dysfunction. Nevertheless, the transcriptional changes underlying this alteration are not well-defined. Microglia activation, a decrease in mitochondrion biogenesis and a subsequent alteration of the redox are common factors in diseases coursing with neuroinflammation. In the last two decades, components of the adenosinergic system have been proposed as potential therapeutic targets to combat neuroinflammation. In this research, we analyzed by RNAseq the gene expression in activated microglia treated with an adenosine A_2A receptor antagonist, SCH 582561, and/or an A₃ receptor agonist, 2-Cl-IB-MECA, since these receptors are deeply related to neurodegeneration and inflammation. The analysis was focused on genes related to inflammation and REDOX homeostasis. It was detected that in the three conditions (microglia treated with 2-Cl-IB-MECA, SCH 582561, and their combination) more than 40 % of the detected genes codified by the mitochondrial genome were differentially expressed (FDR < 0.05) (14/34, 16/34, and 13/34) respectively, being almost all of them (>85 %) upregulated in the microglia treated with adenosinergic compounds. Also, we analyzed the differential expression of genes related to mitochondrial function and oxidative stress codified by the nuclear genome. Additionally, we evaluated the oxygen consumption rate (OCR) of mitochondria in microglia treated with LPS and IFN-γ, both alone and in combination with adenosinergic compounds. The data showed an improvement in mitochondrial function with the antagonist of the adenosine A_2A receptor, compared to the effects of pro-inflammatory stimulus, confirming a functional effect consistent with the RNAseq data.

25 Jul 2024·Journal of Medicinal Chemistry

Lipid Trolling to Optimize A₃ Adenosine Receptor-Positive Allosteric Modulators (PAMs)

Article

Author: Jacobson, Kenneth A. ; Pradhan, Balaram ; Suresh, R. Rama ; Fisher, Courtney L. ; Smith, Brian C. ; Auchampach, John A. ; Salmaso, Veronica ; Gao, Zhan-Guo ; Keyes, Robert F. ; Kumar, T. Santhosh ; Rollison, Noah ; Pavan, Matteo ; Wan, Tina C.

A₃ adenosine receptor (A₃AR) positive allosteric modulators (PAMs) (2,4-disubstituted-1H-imidazo[4,5-c]quinolin-4-amines) allosterically increase the E_max of A₃AR agonists, but not potency, due to concurrent orthosteric antagonism. Following mutagenesis/homology modeling of the proposed lipid-exposed allosteric binding site on the cytosolic side, we functionalized the scaffold, including heteroatom substitutions and exocyclic phenylamine extensions, to increase allosteric binding. Strategically appended linear alkyl-alkynyl chains with terminal amino/guanidino groups improved allosteric effects at both human and mouse A₃ARs. The chain length, functionality, and attachment position were varied to modulate A₃AR PAM activity. For example, 26 (MRS8247, p-alkyne-linked 8 methylenes) and homologues increased agonist Cl-IB-MECA's E_max and potency ([³⁵S]GTPγS binding). The putative mechanism involves a flexible, terminally cationic chain penetrating the lipid environment for stable electrostatic anchoring to cytosolic phospholipid head groups, suggesting "lipid trolling", supported by molecular dynamic simulation of the active-state model. Thus, we have improved A₃AR PAM activity through rational design based on an extrahelical, lipidic binding site.

News (Medical) associated with Namodenoson

18 Oct 2024

·www.globenewswire.com

Significant Positive Results from Osteoarthritis Clinical Study in Dogs Treated with Piclidenoson

Data Reported by Can-Fite Veterinary Partner Vetbiolix who already exercised its option for a full license deal worth $325M Ramat Gan, Israel, Oct. 18, 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 that its veterinary partner Vetbiolix reported positive final results from the osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite’s veterinary commercialization partner, which is covering all costs associated with veterinary clinical development, successfully concluded the full study. Vetbiolix already exercised its option to enter into a full in-license agreement with Can-Fite and is obligated to pay Can-Fite an upfront payment, milestone payments and royalties on sales upon regulatory approval, summing up to projected income of $325M to Can-Fite over the next 10 years. The study looked at the effect of 90 days treatment with Piclidenoson at 100 μg/kg and 500 μg/kg twice daily orally in dog patients with osteoarthritis. Including all evaluable patients, the primary objective was the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire for the assessment of symptoms severity evaluated on dog’s mobility. The secondary objectives included Visual Analog Scale (VAS) for pain assessment by pet parents and Numerical Rating Score (NRS) for (i) lameness and (ii) pain assessment by the veterinarian. The study reached the primary and secondary endpoints with a dose and time dependent inhibitory effect of Piclidenoson on LOAD and VAS, together with a favorable trend on NRS scores, demonstrating significant improvement in clinical status and decrease in pain utilizing the 500 µg/kg dose. The canine osteoarthritis market is projected to reach $3 billion by 2028. There is a clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs), which only treat symptoms and carry significant harmful side effects, and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease. “The final data from the osteoarthritis study are very encouraging and this veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canine, and potentially contribute to near-term revenues. We are very pleased to work productively with the team at Vetbiolix.” stated Can-Fite VP of business Development Dr. Sari Fishman. About Piclidenoson Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity. 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. About VETBIOLIX SAS VETBIOLIX develops innovative products for the treatment and prevention of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class oral small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs in periodontitis (VBX-1000; Cathepsin-K inhibitor), osteoarthritis (VBX-2000; Adenosin-A3 agonist) and gut motility disorders (VBX-3000; 5-HT4 agonist). VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry. For more information please visit: https://www.vetbiolix.com Contact: matthieu.dubruque@vetbiolix.com Forward-Looking StatementsThis 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. Contact Can-Fite BioPharmaMotti Farbsteininfo@canfite.com+972-3-9241114

Clinical ResultPhase 2Orphan DrugLicense out/inPhase 3

07 Oct 2024

·www.globenewswire.com

Join Can-Fite’s Exclusive Live Investor Webinar and Q&A Session on October 29

RAMAT GAN, Israel , Oct. 07, 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, invites investors to a webinar on October 29, 2024, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature Can-Fite Chief Executive Officer Motti Farbstein and Executive Chairperson and Chief Scientific Officer Dr. Pnina Fishman, who will share insight into the Company’s current development pipeline and upcoming milestones. Strategically positioned with multiple out-licensing deals and potential milestone payments totaling over $450 million, Can-Fite has already received $20 million in upfront and milestone payments, underscoring the potential of its therapies. With advanced-stage assets targeting unmet medical needs in markets with a combined value in excess of $70 billion, Can-Fite believes it is well positioned for the potential commercialization of its innovative therapies. To register for the free webinar, please visit: https://redchip.zoom.us/webinar/register/WN_3UZ8u9huRsmIbV216KrdwA#/registration Questions can be pre-submitted to CANF@redchip.com or online during the live event. 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 profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: https://www.canfite.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. Contacts Can-Fite BioPharma Motti Farbstein info@canfite.com +972-3-9241114 Dave GentryRedChip Companies, Inc.CANF@redchip.com 1-407-644-4256

Phase 2Orphan DrugClinical ResultPhase 3Fast Track

16 Sep 2024

·www.globenewswire.com

Can-Fite: Pancreatic Carcinoma Phase IIa Clinical Study with Namodenoson Received Regulatory Authorization from the Israeli Ministry of Health

Study will aim to establish safety and clinical efficacy PETACH TIKVA, Israel, Sept. 16, 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 that it received approval from the Israeli Ministry of Health (MoH) to conduct Phase IIa clinical trial with orally-administered Namodenoson in the treatment of pancreatic carcinoma. “We are very much encouraged by the excellent data in the pre-clinical studies demonstrating the impressive anti-cancer effect of namodenoson and definitive molecular mechanism of action against pancreatic carcinoma,” stated Dr. Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. “We are very keen to initiate the study in this devastating disease and are pleased with the regulatory approval of the Israeli MOH. We do hope that as we have shown efficacy in patients with advanced liver cancer studies, we will be able to demonstrate safety and efficacy in the pancreatic cancer patient population.” The Phase IIa is 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). The study will be conducted by Dr. Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel and by Dr. Al Mutar from the UT Southwestern Medical Center in the US. 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. 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.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. Contact Can-Fite BioPharmaMotti Farbsteininfo@canfite.com+972-3-9241114

Phase 2Clinical ResultOrphan DrugFast Track

100 Deals associated with Namodenoson

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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	RO	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	BA	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	SK	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	US	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	PL	Can-Fite BioPharma Ltd.	15 Mar 2023
Advanced Hepatocellular Carcinoma	Phase 3	BG	Can-Fite BioPharma Ltd.	15 Mar 2023
Hepatocellular Carcinoma	Phase 3	CN	Shenzhen Kangzhe Pharmaceutical Co., Ltd.	-
Liver Cancer	Discovery	US	Can-Fite BioPharma Ltd.	11 Oct 2021

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	ffojthpysv(ztfvumdeoz) = omrmymkotz ovzxlwlifp (vttklxtggc ) View more	Positive	02 Sep 2022
				Placebo	ffojthpysv(ztfvumdeoz) = iqxkjlmboh ovzxlwlifp (vttklxtggc )
NCT02128958 (CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	78	CF102 (CF102)	ptkvpkgabr(gfovotajuk) = tctjahnbao ephkztyoup (eyclfonorj, bkdhzshbnc - jjorgsqvsm) View more	-	29 Dec 2021
				Placebo (Placebo Tablets of CF102)	ptkvpkgabr(gfovotajuk) = wphxldswtv ephkztyoup (eyclfonorj, ffklkwglgs - ldwkixamic) View more
NCT02927314 (Pubmed \| Aliment Pharmacol Ther)	Phase 2	Fatty Liver \| Metabolic dysfunction-associated steatotic liver disease	60	Namodenoson 25 mg b.d.	ciwxnmwigu(npfznvccfz) = nymnaimwyr lkxjstyjan (drfdrsccsi )	-	20 Oct 2021
				Placebo	ciwxnmwigu(npfznvccfz) = dfhixqhvbz lkxjstyjan (drfdrsccsi )
NCT02128958 (Pubmed) Manual	Phase 2	Fibrosis \| Advanced Hepatocellular Carcinoma Second line	78	Namodenoson	(lbbapydzvx) = qypyytzwar lgyxoelhkk (apbhdburjx ) View more	Positive	07 Jan 2021
				Placebo	(lbbapydzvx) = ekvtfxksxi lgyxoelhkk (apbhdburjx ) View more
NCT02128958 (ASCO2019) Manual	Phase 2	Advanced Hepatocellular Carcinoma Second line	78	Namodenoson 25 mg	(lwdpihruxj) = caxqxiwpdz joopactaiv (jpefbnaski )	Positive	02 Jun 2019
				placebo	(lwdpihruxj) = nssvfrberc joopactaiv (jpefbnaski )
NCT00790673 (CTgov)	Phase 1/2	Chronic hepatitis C genotype 1	32	CF102 (Cohort 1 CF102 1 mg qd)	colahllihu(lpamzqqkdh) = fudbjiamgr skcjxoztoz (zxhegdjgnh, pwbxytmfdp - kagowbjvcc) View more	-	15 Apr 2015
				CF102 (Cohort 2 CF102 1 mg Bid)	colahllihu(lpamzqqkdh) = dljjsahpvv skcjxoztoz (zxhegdjgnh, gtvtdplmkc - bjbxojhluw) View more
NCT00790218 (CTgov)	Phase 1/2	Advanced Hepatocellular Carcinoma	19	CF102 (CF102 1mg)	(iwpdscuyyb) = ymqrgmpttb vseducnyjk (jisxbnirbt, jfzuzdgazu - jobjooixyo) View more	-	27 Feb 2015
				CF102 (CF102 5mg)	(iwpdscuyyb) = xudfbncuha vseducnyjk (jisxbnirbt, vsqszfqajc - feyngmphsj) View more
NCT00790218 (Pubmed \| Oncologist)	Phase 1/2	Hepatocellular Carcinoma	19	CF102 1 mg BID	(wusccsgreg) = bqflnpwbqf hobryetxwk (srmncsphpu )	-	01 Jan 2013
				CF102 5 mg BID	(wusccsgreg) = ibthvlckfl hobryetxwk (srmncsphpu )

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