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

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

Can-Fite: New Phase III Psoriasis Data Showing Superior Safety & Improved Efficacy Presented by KOL Dr. Papp at the 31st European Academy of Dermatology (Businesswire) - "Dr. Papp commented, '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.'"

Media quote • Psoriasis

Treatment of plaque psoriasis with piclidenoson: Efficacy and safety results from a phase 3 clinical trial (COMFORT) (EADV 2022) - No abstract available

Clinical • Late-breaking abstract • P3 data • Dermatology • Immunology • Psoriasis

Can-Fite Selected to Present the Positive Psoriasis Phase III Data at the 31st European Academy of Dermatology and Venerology Congress (Businesswire) - "The study is co-authored by numerous dermatology key opinion leaders, researchers, and investigators, in Europe, Israel, and Canada, including Dr. Papp who is leading the design of Can-Fite's pivotal Phase III psoriasis registration trial, which will be submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for market clearance of Piclidenoson in the treatment of moderate to severe psoriasis."

"$CANF Can-Fite: Reports Progress in the Development of Piclidenoson for Osteoarthritis in Pets Through its Partner Vetbiolix https://t.co/32qFrTPTog" (@stock_titan)

Immunology • Osteoarthritis • Pain • Rheumatology

CF101. The 63 Year-old Man with a BMI of 51 Presenting for Elective Major Inpatient Abdominal Surgery; Really? What's the Big Deal? (ASA 2022) - "Review intraoperative management strategies that address the concerns for the patient with obesity. Prescribe a feasible postoperative management plan for safe care in the patient with obesity."

Clinical • Anesthesia • Genetic Disorders • Obesity

CF101 Therapy in Patients With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=528 | Completed | Sponsor: Can-Fite BioPharma | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Activation of adenosine A3 receptor attenuates progression of osteoarthritis through inhibiting the NLRP3/caspase-1/GSDMD induced signalling. (PubMed, J Cell Mol Med) - "The pre-treatment with CF101 powerfully inhibited the above process both in vivo and in vitro. Our findings demonstrated that activation of A3AR attenuates OA progression and relieves pain perception through suppression of cartilage degradation and inhibition of ROS/NLRP3/GSDMD signalling, indicating pyroptosis is a potential candidate for OA treatment."

Journal • Immunology • Inflammation • Musculoskeletal Pain • Neuralgia • Oncology • Osteoarthritis • Pain • Rheumatology • IL18 • IL1B • NLRP3

Drugs Targeting the A3 Adenosine Receptor: Human Clinical Study Data. (PubMed, Molecules) - "Piclidenoson and namodenoson are A3AR agonists with high affinity and selectivity to A3AR. A phase IIb study in NASH is currently enrolling patients. In conclusion, A3AR agonists are promising drug candidates in advanced stages of clinical development and demonstrate safety and efficacy in their targeted indications."

Journal • Review • Dermatology • Fibrosis • Gastrointestinal Cancer • Hepatology • Immunology • Liver Cancer • Non-alcoholic Steatohepatitis • Oncology • Psoriasis • Solid Tumor