piclidenoson (CF101) / Can-Fite, Gebro, Cipher, China Medical System, Ewopharma - LARVOL DELTA

Can-Fite’s Latest Developments of its Advanced Stage Drug Pipeline will be Presented at Noble Capital Markets 21st Annual Emerging Growth Equity Conference (GlobeNewswire) - "Mr. Farbstein will present the latest developments in Can-Fite’s advanced stage drug development pipeline including the following trials: Phase III liver cancer; Phase IIa pancreatic cancer; Phase III psoriasis; Phase IIb MASH..."

Trial status • Liver Cancer • Metabolic Dysfunction-Associated Steatohepatitis • Pancreatic Cancer • Psoriasis

CF 101 for New Pediatric Psychosocial Clinicians (NACFC 2025) - No abstract available

Clinical • Pediatrics

CF 101 for New Adult Psychosocial Clinicians (NACFC 2025) - No abstract available

Clinical

Can-Fite Reports H1 2025 Financial Results… (GlobeNewswire) - "Research and development expenses for the first half of 2025 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH."

Commercial • Hepatocellular Cancer • Metabolic Dysfunction-Associated Steatohepatitis • Psoriasis

Local anti-inflammatory effect in a psoriasis model using a photoswitchable drug, A3 adenosine receptor agonist MRS7787 (ACS-Fall 2025) - "The agonist structure was designed based on the experimental anti-inflammatory drug Piclidenoson (IB-MECA, Phase 3 for psoriasis)...As a result, our photoswitchable agonist MRS7787 allowed the precise modulation of A3R function both in vitro and in vivo, which led to a clear light-controlled pharmacotherapeutic effect on mouse skin lesions, induced by subcutaneous injection of IL-23. This breakthrough not only demonstrates the potential of diazocine photoswitches for in vivo photopharmacology but also paves the way for the development of new strategies for skin-related diseases that require localized and temporally controlled drug action."

Dermatology • Immunology • Psoriasis • IL23A

Molecular basis of ligand binding and receptor activation at the human A3 adenosine receptor. (PubMed, Nat Commun) - "In addition, we identify a cryptic pocket that accommodates the N6-iodobenzyl group of Piclidenoson through a ligand-dependent conformational change of M1745.35. Our comprehensive structural and functional characterisation of A3AR advances our understanding of adenosine receptor pharmacology and establishes a foundation for developing more selective therapeutics for various disorders, including inflammatory diseases, cancer, and glaucoma."

Journal • Glaucoma • Oncology • Ophthalmology

Breakthrough Study from UCLA Demonstrate Can-Fite’s Piclidenoson as a Treatment for Vascular Dementia (GlobeNewswire) - "Can-Fite BioPharma Ltd...announced that a leading group from University of Los Angeles (UCLA), demonstrate that Piclidenoson showed efficacy in an experimental model of vascular dementia...The study headed by Dr. S. Thomas Carmichael...utilized a vascular dementia mouse model with focal ischemia replicating many elements of the complex pathophysiology of human vascular dementia. Piclidenoson was found to restore tissue integrity and behavioral function in this vascular dementia model."

Preclinical • CNS Disorders • Dementia

Can-Fite Has Raised $175 Million in Total to Date for the Development of Namodenoson and Piclidenoson, Advancing into Pivotal Phase 3 Trials in Liver Cancer and Psoriasis (GlobeNewswire) - "Can-Fite BioPharma Ltd...announced that, it has raised $175 million in funding to date. These funds have enabled the advancement of its lead drug candidates, Namodenoson and Piclidenoson, into pivotal Phase III studies for liver cancer and psoriasis, respectively."

Financing • Liver Cancer • Psoriasis

A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy (clinicaltrials.gov) - P3 | N=705 | Not yet recruiting | Sponsor: Can-Fite BioPharma | Initiation date: Mar 2025 ➔ Jun 2025

Trial initiation date • Dermatology • Immunology • Psoriasis

Can-Fite to Generate $685M in Projected Future Revenues from its Partnerships (GlobeNewswire) - "Can-Fite BioPharma Ltd....today announced the completion of a comprehensive analysis of its current partnerships and the market potential for its lead drug candidates, Piclidenoson and Namodenoson upon regulatory approvals....Based on in-depth internal modeling and insights from external advisors, the Company forecasts potential substantial revenue generation over the next decade from its two drug candidates, currently in development for four key indications: psoriasis, advanced liver cancer, pancreatic cancer, and MASH, which assumes, among other things, regulatory approval and launches between 2027 and 2029, depending on the indication and territory."

Approval • Commercial • Launch • Hepatocellular Cancer • Liver Cancer • Metabolic Dysfunction-Associated Steatohepatitis • Pancreatic Cancer • Psoriasis

Can-Fite Initiates Pivotal Phase 3 Psoriasis Study of its Oral Drug Piclidenoson with FDA & EMA-Approved Protocol (GlobeNewswire) - "Can-Fite BioPharma Ltd...today announced that it initiated a pivotal phase 3 psoriasis study of its oral drug Piclidenoson with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) - approved clinical study protocol. The study will enroll patients with moderate to severe plaque psoriasis. Patient enrolment will be initiated in Europe and US and Canada expected to follow....Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA."

EMA filing • FDA filing • Trial status • Psoriasis

Can-Fite to Initiate Phase II Study in the Rare Genetic Disease Lowe Syndrome with Piclidenoson (GlobeNewswire) - "Can-Fite BioPharma Ltd...today announced that a Phase II design is completed and preparatory work is undergoing for the initiation of clinical study in the rare genetic disease Lowe Syndrome...The Phase II open study will enroll 5 patients that will be treated twice daily with 3 mg Piclidenoson for 12 months. The study’s primary end point will be the efficacy of Piclidenoson in increasing 99mTc-DMSA renal uptake."

Clinical • Clinical protocol • Genetic Disorders

Local delivery of an adenosine receptor agonist reduces inflammation associated with contact hypersensitivity. (PubMed, Drug Deliv Transl Res) - "To our knowledge, this is the first demonstration of therapeutic efficacy of IBMECA in CHS, as well as the first proof-of-principle demonstration of IBMECA application in the context of a local drug delivery system. Ultimately, this delivery system has the potential to be adapted for use in other T-cell mediated inflammatory conditions (e.g., transplant rejection), suggesting broader implications of this study."

Journal • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Transplant Rejection • Transplantation

Efficacy and safety of Piclidenoson in the treatment of plaque psoriasis: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Arch Dermatol Res) - "Piclidenoson demonstrates a significant improvement in PGA scores and a favorable safety profile, suggesting it could be a valuable addition to plaque-like psoriasis treatment. Further research with larger, longer-term RCTs is needed to confirm its efficacy and optimize clinical use."

Clinical • Journal • Retrospective data • Review • Dermatology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Musculoskeletal Diseases • Psoriasis

A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy (clinicaltrials.gov) - P3 | N=705 | Not yet recruiting | Sponsor: Can-Fite BioPharma

New P3 trial • Dermatology • Immunology • Psoriasis

Can-Fite Reports First Half 2024 Financial Results & Progress in Two Pivotal Phase III Clinical Studies (GlobeNewswire) - "Research and development expenses for the six months ended June 30, 2024 were $2.89 million compared with $3.42 million for the same period in 2023. Research and development expenses for the first half of 2024 comprised primarily of expenses associated with the two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for NASH. The decrease is primarily due to a decrease in expenses associated with Piclidenoson."

Commercial • Gastrointestinal Cancer • Hepatocellular Cancer • Immunology • Liver Cancer • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Oncology • Solid Tumor

Adenosine A3 Receptor: From Molecular Signaling to Therapeutic Strategies for Heart Diseases. (PubMed, Int J Mol Sci) - "Several A3AR-specific agonists, such as piclidenoson and namodenoson, exert cardioprotective impacts during ischemia in the diverse animal models of heart disease. Thus, modulating A3ARs serves as a potential therapeutic approach, fueling considerable interest in developing compounds that target A3ARs as potential treatments for heart diseases."

Journal • Review • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Hypertension

Cryo-EM structures of adenosine receptor A3AR bound to selective agonists. (PubMed, Nat Commun) - "The selective A3AR agonists, CF101 and CF102, are clinically significant, yet their recognition mechanisms remained elusive. Comparative analysis with the inactive A2AAR structure highlights a conserved receptor activation mechanism. Our findings provide comprehensive insights into the molecular recognition and signaling of A3AR, paving the way for designing subtype-selective adenosine receptor ligands."

Journal • Oncology

Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT-1). (PubMed, J Eur Acad Dermatol Venereol) - P3 | "Piclidenoson 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)."

Journal • P3 data • Dermatology • Immunology • Psoriasis • IL17A • IL23A

DG03--What's the Play Coach?- The Pharmacy Team Playbook for CF (Team Pharmacy CF 101) (NACFC 2023) - "Analyze new and changing roles and responsibilities for pharmacists and pharmacy technicians. Formulate strategies to navigate current medication access challenges and foster medication adherence."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

CF101. Controversies in High-Risk Anesthesia and Critical Care (ASA 2023) - "DESCRIPTION This interactive scenario will explore four to five perioperative decision dilemmas in the context of perioperative case management. Decision guidance will involve literature review, audience participation, and expert opinion."

Anesthesia • Critical care

Can-Fite Reports First Quarter 2023 Financial Results & Provides Clinical Update (Businesswire) - "A Phase 2b NASH study is currently ongoing to evaluate Namodenoson’s efficacy as compared to placebo...Namodenoson met its primary endpoint of reducing liver fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect in a prior Phase 2a NASH study....The European Medicines Agency (EMA) gave Can-Fite a positive opinion on its registration plan for a pivotal Phase 3 clinical trial for Piclidenoson in the treatment of moderate to severe psoriasis...Can-Fite has submitted a comparable data package to the U.S. Food and Drug Administration (FDA) and expects a similar response....Research and development expenses for the three months ended March 31, 2023 were $2.06 million, an increase of $0.24 million, or 13.17%, compared to $1.82 million for the three months ended March 31, 2022....The increase is primarily due to an increase in expenses associated with Namodenoson."

Commercial • European regulatory • FDA event • Trial status • Dermatology • Fibrosis • Immunology • Non-alcoholic Steatohepatitis • Psoriasis

New synthetic pharmacotherapeutic approaches to the treatment of moderate-to-severe plaque psoriasis in adults. (PubMed, Expert Opin Pharmacother) - "Cost is also a barrier for many patients. Recent development of new synthetic treatment options is promising, and we recommend that providers consider these agents as they develop holistic and individualized treatment plans for their patients."

Journal • Dermatology • Immunology • Psoriasis

Can-Fite to Conduct Meetings at the BIO-Europe Spring Conference with Pharma Companies Interested in Licensing and Distributing Piclidenoson and Namodenoson (Businesswire) - "Can-Fite BioPharma Ltd...announced today that Dr. Sari Fishman, the Company’s Vice President of Business Development, will participate in the BIO-Europe Spring^® partnering conference in Basel, Switzerland from March 20 to 22, 2023. Dr. Fishman will conduct one-on-one meetings with a substantial number of potential partners interested in licensing and distribution arrangements for Can-Fite’s advanced-stage drug candidates Piclidenoson and Namodenoson."

Licensing / partnership • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Psoriasis

This Company Is Racing Toward Providing Comfort And Safety To Millions Of Psoriasis Sufferers (Benzinga) - "'The safety results on Piclidenoson and its progressive effectiveness over the study period position it as unique among the current treatment options - especially given the chronic nature of psoriasis, which can necessitate long-term treatment,' Papp said."

Media quote • Psoriasis