A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Piclidenoson (CF101) Administered Orally in Subjects With Moderate-to-Severe Plaque Psoriasis

This is a double-blind, placebo-controlled study in adults with a diagnosis of moderate-to-severe chronic plaque psoriasis to test the efficacy and safety of piclidenoson in this patient population.

Start Date01 Mar 2025

Sponsor / Collaborator

Can-Fite BioPharma Ltd.

EUCTR2021-002009-85-BG

/ Not yet recruitingPhase 2

Piclidenoson for Treatment of COVID-19 - A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

Start Date12 Aug 2021

Sponsor / Collaborator

Can-Fite BioPharma Ltd.

NCT04333472

/ CompletedPhase 2

Piclidenoson for Treatment of COVID-19 - A Randomized, Double-Blind, Placebo-Controlled Trial

Patients with documented moderate COVID-19 infection will be randomized 1:1 to receive piclidenoson 2 mg Q12H orally with standard supportive care (SSC - intervention arm) or placebo orally with SSC (control arm) for up to 28 days.

Start Date06 Jan 2021

Sponsor / Collaborator

Can-Fite BioPharma Ltd.

[+1]

100 Clinical Results associated with Piclidenoson

100 Translational Medicine associated with Piclidenoson

100 Patents (Medical) associated with Piclidenoson

225

Literatures (Medical) associated with Piclidenoson

01 Jun 2024·Journal of the European Academy of Dermatology and Venereology

Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT‐1)

Article

Author: Papp, K A ; Brezoev, P ; Harpaz, Z ; Trailovic, N ; Celic, M ; Blicharski, T ; Silverman, M H ; Groppa, L ; Kalicka-Dudzik, M ; Fishman, P ; Calin, C A ; Ramon, M ; Gantcheva, M L ; Slavcheva Simeonova, E ; Beyska-Rizova, S ; Bareket-Samish, A ; Farbstein, M ; Selmanagic, A

AbstractObjectiveA3 adenosine receptor (A3AR) is overexpressed in the skin and peripheral blood mononuclear cells of psoriasis patients. We investigated the efficacy/safety of piclidenoson (CF101), an orally bioavailable A3AR agonist that inhibits IL‐17 and IL‐23 production in keratinocytes, in moderate‐to‐severe plaque psoriasis.MethodsThe randomized, placebo‐ and active‐controlled, double‐blind phase 3 COMFORT‐1 trial randomized patients (3:3:3:2) to piclidenoson 2 mg BID, piclidenoson 3 mg BID, apremilast 30 mg BID or placebo. At Week 16, patients in the placebo arm were re‐randomized (1:1:1) to piclidenoson 2 mg BID, piclidenoson 3 mg BID or apremilast 30 mg BID. The primary end point was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI‐75) at Week 16 versus placebo.ResultsA total of 529 patients were randomized and received ≥1 dose of study medication (safety population). The efficacy analysis population for the primary end point included 426 patients (piclidenoson 2 mg BID, 127; piclidenoson 3 mg BID, 103; apremilast, 118; placebo, 78). Piclidenoson at 2 and 3 mg BID exhibited similar efficacy. The primary end point was met with the 3 mg BID dose: PASI 75 rate of 9.7% versus 2.6% for piclidenoson versus placebo, p = 0.037. The PASI responses with piclidenoson continued to increase throughout the study period in a linear manner. At week 32, analysis in the per‐protocol population showed that a greater proportion of patients in the piclidenoson 3 mg BID arm (51/88, 58.0%) achieved improvement from baseline in Psoriasis Disability Index (PDI) compared to apremilast (59/108, 55.1%), and the test for noninferiority trended towards significance (p = 0.072). The safety/tolerability profile of piclidenoson was excellent and superior to apremilast.ConclusionsPiclidenoson demonstrated efficacy responses that increased over time alongside a favourable safety profile. These findings support its continued clinical development as a psoriasis treatment (ClinicalTrials.gov identifier: NCT03168256).

01 May 2024·International Immunopharmacology

Manual acupuncture ameliorates inflammatory pain by upregulating adenosine A3 receptor in complete Freund’s adjuvant-induced arthritis rats

Article

Author: Du, Hong ; Xu, Shang-Cheng ; Yang, Qian ; Qu, Fei ; Ke, Hong ; Cui, Yan-Ru ; Ouyang, Qian-Wen ; Xu, Jing-Ping ; Shao, Mei-Juan

BACKGROUNDAdenosine A₃ receptor (A₃R) exerts analgesic, anti-inflammatory, and anti-nociceptive effects. In this study, we determined the analgesic mechanism of manual acupuncture (MA) in rats with complete Freund's adjuvant (CFA)-induced arthritis and explored whether MA ameliorates inflammation in these rats by upregulating A₃R.METHODSSixty Sprague Dawley (SD) rats were randomly divided into the following groups: Control, CFA, CFA + MA, CFA + sham MA, CFA + MA + DMSO, CFA + MA + IB-MECA, and CFA + MA + Reversine groups. The arthritis rat model was induced by injecting CFA into the left ankle joints. Thereafter, the rats were subjected to MA (ST36 acupoint) for 3 days. The clinical indicators paw withdrawal latency (PWL), paw withdrawal threshold (PWT), and open field test (OFT) were used to determine the analgesic effect of MA. In addition, to explore the effect of A₃R on inflammation after subjecting arthritis rats to MA, IB-MECA (A₃R agonist) and Reversine (A₃R antagonist) were injected into ST36 before MA.RESULTSMA ameliorated the pathological symptoms of CFA-induced arthritis, including the pain indicators PWL and PWT, number of rearing, total ambulatory distance, and activity trajectory. Furthermore, after MA, the mRNA and protein expression of A₃R was upregulated in CFA-induced arthritis rats. In contrast, the protein levels of TNF-α, IL-1β, Rap1, and p-p65 were downregulated after MA. Interestingly, the A₃R agonist and antagonist further downregulated and upregulated inflammatory cytokine expression, respectively, after MA. Furthermore, the A₃R antagonist increased the degree of ankle swelling after MA.CONCLUSIONMA can alleviate inflammatory pain by inhibiting the NF-κB signaling pathway via upregulating A₃R expression of the superficial fascia of the ST36 acupoint site in CFA-induced arthritis rats.

01 Dec 2022·Neurochemical Research

Adenosine as a Key Mediator of Neuronal Survival in Cerebral Ischemic Injury

Review

Author: Grewal, Amarjot Kaur ; Kaur, Parneet ; Khan, Heena ; Singh, Thakur Gurejet ; Sood, Shreya

Several experimental studies have linked adenosine's neuroprotective role in cerebral ischemia. During ischemia, adenosine is formed due to intracellular ATP breakdown into ADP, further when phosphate is released from ADP, the adenosine monophosphate is formed. It acts via A1, A2, and A3 receptors found on neurons, blood vessels, glial cells, platelets, and leukocytes. It is related to various effector systems such as adenyl cyclase and membrane ion channels via G-proteins. Pharmacological manipulation of adenosine receptors by agonists (CCPA, ADAC, IB-MECA) increases ischemic brain damage in various in vivo and in vitro models of cerebral ischemia whereas, agonist can also be neuroprotective. Mainly, receptor antagonists (CGS15943, MRS1706) indicated neuroprotection. Later, various studies also revealed that the downregulation or upregulation of specific adenosine receptors is necessary during the recovery of cerebral ischemia by activating several downstream signaling pathways. In the current review, we elaborate on the dual roles of adenosine and its receptor subtypes A1, A2, and A3 and their involvement in the pathobiology of cerebral ischemic injury. Adenosine-based therapies have the potential to improve the outcomes of cerebral injury patients, thereby providing them with a more optimistic future.

News (Medical) associated with Piclidenoson

30 Dec 2024

·ir.canfite.com

Recognition of the American Society of Clinical Oncology (ASCO) of the Liver Protective Effect of Can-Fite’s anti-Cancer Drug Namodenoson

Can-Fite’s data will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium Can-Fite enrolls patients for its pivotal Phase III advanced liver cancer study Ramat Gan, Israel, Dec. 30, 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 Oncology and Inflammatory diseases, today announced that its work titled “The Liver Protective Effect of the anti-Cancer Drug Candidate Namodenoson is Mediated via Adiponectin” will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium to take place at San Francisco & On Line, January 23-25. Currently, Namodenoson is being evaluated in a pivotal Phase 3 multinational registrational trial for the treatment of advanced liver cancer (Hepatocellular Carcinoma; HCC). Interestingly, Namodenoson has also completely cleared cancer in an HCC patient who was enrolled in Can-Fite’s Phase 2b HCC trial. The patient continues to be treated through a compassionate use program in Romania, where she remains cancer-free for more than 8 years following her first dose of Namodenoson. The uniqueness of Namodenoson is that beyond its anti-cancer activity, it also induces a liver-protective effect. The latter is manifested by anti-steatosis, anti-inflammatory, anti-fibrotic, and anti-ischemic effects in the liver. Can-Fite researchers also found that the molecular mechanism of the protective effect is mediated via adiponectin protein, a positive cytokine released by adipocytes and endothelial cells in the body, known to induce liver-, cardio-, and neuro-protective effects. Namodenoson has received significant acknowledgment in the scientific and medical communities, as evidenced by the numerous peer-reviewed publications and conferences, in which it has been published and presented. “Our Phase 3 registrational trial is designed to treat patients who have tried, yet not benefitted from the few other FDA-approved HCC treatments on the market today. In distinction from these drugs which induce liver toxicity on top of their anti-cancer effect, Namodenoson has the advantage of having a liver-protective effect and therefore can be administered to patients with advanced disease,” stated Can-Fite CSO & Chairperson Dr. Pnina Fishman. We are hopeful that Namodenoson, with its liver-protective properties, can safely prolong life for advanced liver cancer patients.” 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 MASH 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: 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. Contact Can-Fite BioPharma Motti Farbstein info@canfite.com +972-3-9241114 Released December 30, 2024

Phase 2Orphan DrugClinical ResultPhase 3ASCO

04 Dec 2024

·www.globenewswire.com

8 Years Survival with Complete Cure for a Patient with Advanced Liver Cancer Being Treated with Can-Fite’s Namodenoson Drug

RAMAT GAN, Israel, Dec. 04, 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, announced today that a patient currently treated with Namodenoson in a compassionate use program in Can-Fite’s Phase II Liver Cancer Study has an overall survival time of 8 years with a complete response. The patient, who suffered from advanced liver cancer was enrolled in the former Can-Fite Phase II study, continue to be treated with Namodenoson, and has now an overall survival of 8 years, with disappearance of ascites, normal liver function, good quality of life and is defined as a long term complete response. Can-Fite is currently enrolling patients in Israel, Europe and the US for a pivotal Phase III clinical study for patients with advanced HCC as a 2nd or 3rd line treatment and Namodenoson is administered twice daily orally. The study protocol has been agreed upon with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania. “With a very favorable safety profile and anti-cancer effect of Namodenoson, we are now enrolling patients for the pivotal Phase III clinical study where we expect to prolong patients’ overall survival, and see a response similar to that of the patient who has now been treated with Namodenoson for 8 years. The uniqueness of Namodenoson which specifically acts against the tumor cells and protects the normal liver cells, is the rationale for the conductance of the current trial,” stated Prof. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel. 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. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1 billion by 2027 for the G8 countries. 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 MASH 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: 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. Contact Can-Fite BioPharmaMotti Farbsteininfo@canfite.com+972-3-9241114

Phase 2Orphan DrugClinical ResultPhase 3Fast Track

11 Nov 2024

·www.globenewswire.com

Can-Fite Achieves Milestone with First Patient Dosing in Pancreatic Cancer Phase IIa Clinical Trial

Orphan Drug Designation has been granted lately by US FDA RAMAT GAN, Israel, Nov. 11, 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 announces the dosing of the first patient in the Phase IIa clinical trial in patients with advanced pancreatic adenocarcinoma (NCT06387342). “We are excited to have the first patient enrolled and hope that we will be able to demonstrate the safety and efficacy of Namodenoson in the pancreatic cancer patient population. This trial provides us the opportunity to explore our innovative treatment approach for patients who are facing significant gaps in effective treatment options,” stated Dr. Michael Silverman, Can-Fite’s Medical Officer. The Phase IIa study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first-line therapy. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. All patients receive oral Namodenoson 25 mg, administered twice daily for consecutive 28-day cycles. Patients are being 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 is being conducted by Dr. Salomon 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. Orphan Drug Designation has been granted lately by US FDA. 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 MASH 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: 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. ContactCan-Fite BioPharmaMotti Farbsteininfo@canfite.com+972-3-9241114

Phase 2Orphan DrugClinical ResultFast Track

100 Deals associated with Piclidenoson

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D10971	-	-	DB05511

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	NDA/BLA	EU	Can-Fite BioPharma Ltd.	10 Jan 2023
Psoriasis	Phase 3	US	Can-Fite BioPharma Ltd.	-
Psoriasis	Phase 3	CN	Shenzhen Kangzhe Pharmaceutical Co., Ltd.	-
Rheumatoid Arthritis	Phase 2	CA	Can-Fite BioPharma Ltd.	30 Oct 2017
Rheumatoid Arthritis	Phase 2	IL	Can-Fite BioPharma Ltd.	30 Oct 2017
Rheumatoid Arthritis	Phase 2	BA	Can-Fite BioPharma Ltd.	30 Oct 2017
Rheumatoid Arthritis	Phase 1	IL	Can-Fite BioPharma Ltd.	30 Oct 2017
Rheumatoid Arthritis	Phase 1	BA	Can-Fite BioPharma Ltd.	30 Oct 2017
Rheumatoid Arthritis	Phase 1	CA	Can-Fite BioPharma Ltd.	30 Oct 2017
Kerato conjunctivitis sicca	Phase 1	IL	Can-Fite BioPharma Ltd.	01 Jul 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03168256 (COMFORT-1, Pubmed) Manual	Phase 3	Plaque psoriasis	529	Piclidenoson 3 mg BID	(fuwavkhjhy) = lhfrrsrbvd mhpwnufzti (eslfasybvr ) View more	Positive	26 Jan 2024
				Placebo	(fuwavkhjhy) = agejvcoxox mhpwnufzti (eslfasybvr )
NCT03168256 (COMFORT, EADV2022)	Phase 3	Plaque psoriasis A3 adenosine receptor (A3AR)	529	Piclidenoson 3 mg BID	(xewqgwpyrp) = usawywlumb tuauqtjjzx (tgfhcbayjd ) View more	Positive	07 Sep 2022
				Apremilast 30 mg BID	ugmrvwpuba(fcyskczicn) = fhyrzknpud ctehvkstgk (qeesxjocnv )
NCT01033422 (CTgov)	Phase 2	Glaucoma	89	CF101 (CF101 1mg)	ncmrjuwyuz(btfwbmsnrw) = erglwgmdah pqtzudnaub (qunhtkpjmt, rbuaromkzr - qkzqlrxucl) View more	-	23 May 2019
				CF101 (CF101 2mg)	ncmrjuwyuz(btfwbmsnrw) = wvwgcaigtf pqtzudnaub (qunhtkpjmt, iwcrhgkgbh - etvbpapmtn) View more
NCT01265667 (CTgov)	Phase 2/3	Plaque psoriasis	293	CF101 (CF101 2 mg)	pwqvesmjks(ozknhaiycd) = rakcvwtcbi yujvzzngcx (qvylfsdbbn, glsyfwjvzw - vmambimsiw) View more	-	20 Sep 2017
				Placebo (Placebo)	pwqvesmjks(ozknhaiycd) = qgosdsmnau yujvzzngcx (qvylfsdbbn, ujcrymcapc - qbotxvqkww) View more
NCT01265667 (Pubmed) Manual	Phase 2/3	Plaque psoriasis	-	CF101	(birnjawfxr) = gjtsnmmshe axczakayle (hbnmzjxnlf ) View more	Positive	01 Aug 2016
				Placebo	(birnjawfxr) = ictfnkrncd axczakayle (hbnmzjxnlf )
NCT01235234 (CTgov)	Phase 3	Kerato conjunctivitis sicca	236	CF101 (CF101 0.1 mg)	pfvsuscgdh(pfpibgkjvc) = thydizdcsg rvvzdfxdwu (dvortjqrwc, iycfkjvwig - joopqxuums) View more	-	11 Mar 2015
				CF101 (CF101 1 mg)	pfvsuscgdh(pfpibgkjvc) = xudyjlloed rvvzdfxdwu (dvortjqrwc, irfhjrdiaf - xpcxqeevcv) View more
NCT01034306 (CTgov)	Phase 2	Rheumatoid Arthritis	79	Placebo control	iqrygvxcht(rxkdllbttz) = zifzdohdoo oqkyqskwnv (lfejbskxtf, appirhmita - okjifkybso) View more	-	09 Mar 2015
ERS2013	Not Applicable	Asthma	7	adenosine	kbxmrkgzmo(kjwvjswzcf) = gitkoxvpaq pmskeflqce (shlxlcqcqr )	Positive	01 Sep 2013
				adenosine	kbxmrkgzmo(kjwvjswzcf) = imetdnakof pmskeflqce (shlxlcqcqr )
NCT00428974 (CTgov)	Phase 2	Plaque psoriasis	76	Placebo	clcqbropzj(uxxubrdwai) = avpmawffsk oxprbzjcvk (bycfdwwwkd, uhyzekgbkl - xdabevkkha) View more	-	26 Sep 2011
ARVO2007	Not Applicable	-	-	IB-MECA	ocinqbjyuh(tvaptefvgl) = otgomfgbxw wblnevrckd (mrzsmjwsiq )	-	01 May 2007

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