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Can-Fite BioPharma Ltd. (symbol: CANF) is a clinical-stage biopharmaceutical company headquartered at 10 Bareket Street, פ"ת, Israel. This biotechnology firm specializes in the development of orally bioavailable small molecule therapeutic products aimed at treating a range of conditions including cancer, liver, and inflammatory diseases.
The company leverages its proprietary platform technology, which targets the Gi protein associated A3 adenosine receptor (A3AR) to develop its therapeutic candidates. One of its leading drug candidates, Piclidenoson, is currently undergoing a Phase III clinical trial for psoriasis, indicating its advanced stage in the development pipeline.
Another significant product in Can-Fite's portfolio is Namodenoson. This drug is making strides towards addressing liver-related conditions, with a Phase III trial underway for hepatocellular carcinoma (HCC), the most common form of liver cancer. Additionally, it is in a Phase IIb trial for non-alcoholic steatohepatitis (NASH), a serious liver condition with limited treatment options.
Can-Fite BioPharma is committed to improving patient outcomes through innovative therapeutic solutions. The company collaborates with various partners and research institutions to drive its drug development programs forward. Its focus on oral therapeutics provides an added advantage of ease of administration, potentially improving patient compliance and overall treatment efficacy.
This combination of advanced clinical trials, strategic partnerships, and a focused therapeutic approach highlights Can-Fite BioPharma's role as a significant player in the biopharmaceutical industry.
Can-Fite BioPharma (NYSE American: CANF) announced that its lead drug candidate Namodenoson has been granted a US patent for use as an anti-obesity drug. The patent (No. 17/309,952), expiring in 2042, covers methods of treating obese patients with oral Namodenoson.
The drug demonstrated effectiveness by reducing fat levels through increased adiponectin hormone production and showed weight reduction in animal obesity models. In a Phase IIa MASH study, patients treated with Namodenoson experienced a 2.3% weight loss after 3 months with significant adiponectin level increases.
Namodenoson is currently in Phase IIb trials for MASH treatment, where most patients are obese. The global obesity treatment industry is projected to reach $60.5 billion by 2030, with an expected compound annual growth rate of 22.3% from 2025-2030.
Can-Fite BioPharma (NYSE American: CANF) announced that its research on Namodenoson's liver protective effects will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium. The company is currently conducting a pivotal Phase 3 multinational registrational trial for advanced liver cancer treatment. Notably, Namodenoson has shown remarkable results in one HCC patient who has remained cancer-free for over 8 years through a compassionate use program. The drug demonstrates dual benefits: anti-cancer activity and liver-protective effects, including anti-steatosis, anti-inflammatory, anti-fibrotic, and anti-ischemic properties. The protective mechanism works through adiponectin protein, which provides liver-, cardio-, and neuro-protective effects.
Can-Fite BioPharma (NYSE American: CANF) reported remarkable results from their compassionate use program, where a patient with advanced liver cancer treated with Namodenoson has achieved an 8-year survival with complete response. The patient experienced disappearance of ascites, normal liver function, and good quality of life.
The company is currently enrolling patients in Israel, Europe, and the US for a pivotal Phase III clinical study for advanced HCC as a 2nd or 3rd line treatment. Namodenoson, administered orally twice daily, has received Orphan Drug status from both FDA and EMA, along with FDA Fast Track Status for HCC treatment.
The liver cancer treatment market is projected to reach $6.1 billion by 2027 in G8 countries, with liver cancer causing over 700,000 deaths globally each year.
60 Degrees Pharmaceuticals (SXTP) and Can-Fite BioPharma (CANF) will be featured on the RedChip Small Stocks, Big Money show on Bloomberg TV on November 23 at 7 p.m. ET. The program, reaching approximately 73 million U.S. homes, will include interviews with both companies' CEOs. Geoffrey Dow from SXTP will discuss their FDA-approved antimalarial drug ARAKODA and plans to expand its use for diseases like babesiosis. Motti Farbstein from Can-Fite will present their oral drug platform targeting oncology and inflammatory diseases, along with updates on their late-stage clinical pipeline.
Can-Fite BioPharma (NYSE American: CANF) has announced the first patient dosing in its Phase IIa clinical trial for advanced pancreatic adenocarcinoma. The multicenter open-label trial will evaluate Namodenoson, administered orally at 25 mg twice daily, in approximately 20 evaluable patients whose disease has progressed on at least first-line therapy. The study's primary objective is to assess safety, while secondary objectives include evaluating clinical activity through metrics like Objective Response Rate, Progression-Free Survival, and Overall Survival. The trial is being conducted at Rabin Medical Center, Israel, and UT Southwestern Medical Center, US. Notably, Namodenoson has recently received Orphan Drug Designation from the US FDA.
Can-Fite BioPharma (NYSE American: CANF) has received patent allowance in Australia for its drug Namodenoson for anti-obesity treatment, valid until 2040. The patent covers methods of treating obese patients using oral Namodenoson, which has shown promising results in reducing fat levels by increasing adiponectin hormone. In a Phase IIa study for MASH patients, the drug demonstrated a 2.3% weight loss after 3 months with significant increases in adiponectin levels. The drug is currently in Phase IIb trials for MASH treatment, where most patients are obese. The global obesity treatment market was valued at USD 12 billion in 2023, with Australia alone expecting approximately 1.85 Million MASH patients.
Can-Fite BioPharma (NYSE American: CANF) announced positive final results from a multicenter clinical study on dogs with osteoarthritis treated with Piclidenoson. The study, conducted by Can-Fite's veterinary partner Vetbiolix, met its primary and secondary endpoints, showing significant improvement in clinical status and pain reduction at the 500 µg/kg dose.
Vetbiolix has already exercised its option for a full license deal worth $325 million to Can-Fite over the next 10 years. The canine osteoarthritis market is projected to reach $3 billion by 2028. The study results demonstrate Piclidenoson's potential as a safe and effective treatment for canine osteoarthritis, addressing a clear market need.
Can-Fite BioPharma (NYSE American: CANF) (TASE: CANF) is hosting an exclusive live investor webinar and Q&A session on October 29, 2024, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature CEO Motti Farbstein and Executive Chairperson and CSO Dr. Pnina Fishman, who will discuss the company's development pipeline and upcoming milestones.
Can-Fite has multiple out-licensing deals with potential milestone payments exceeding $450 million, having already received $20 million in upfront and milestone payments. The company's advanced-stage assets target unmet medical needs in markets valued at over $70 billion. Investors can register for the free webinar and submit questions in advance or during the live event.
Can-Fite BioPharma (NYSE American: CANF) has announced that its veterinary partner Vetbiolix has exercised its option and signed a development and commercialization agreement for Piclidenoson, targeting osteoarthritis treatment in companion animals. This follows a successful clinical study in dogs. The arthritis market for companion animals is projected to grow from $3.8 Billion in 2023 to $6.3 Billion by 2030.
Can-Fite anticipates potential peak worldwide sales of $445 Million by 2034, capturing up to 6% of the market. The agreement entitles Can-Fite to a 15% royalty on worldwide sales, with projected earnings of $325 million over the next decade, assuming a 2027 launch. Piclidenoson offers a potentially safe and effective oral treatment for canine osteoarthritis, addressing limitations of current treatments.
Can-Fite BioPharma (NYSE American: CANF) has received approval from the Israeli Ministry of Health to conduct a Phase IIa clinical trial for Namodenoson in treating pancreatic carcinoma. The multicenter, open-label trial will enroll approximately 20 evaluable patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy. Patients will receive 25 mg of oral Namodenoson twice daily in 28-day cycles.
The study aims to establish safety and clinical efficacy. Primary objectives include characterizing Namodenoson's safety profile, while secondary objectives involve evaluating clinical activity through metrics such as Objective Response Rate, Progression-Free Survival, and Overall Survival. The trial will be conducted at the Rabin Medical Center in Israel and UT Southwestern Medical Center in the US.