Can-Fite BioPharma Ltd. reports developments for a clinical-stage biotechnology pipeline of proprietary small-molecule drugs targeting the A3 adenosine receptor (A3AR). Recurring news covers Namodenoson and Piclidenoson across oncology, inflammatory disease, liver disorders, metabolic disease, obesity-related uses, and companion-animal osteoarthritis through its veterinary commercialization relationship.
Company updates also include clinical and regulatory disclosures, patent allowances in multiple jurisdictions, operating and financial results, material agreements, capital-structure actions, and governance matters tied to its American Depositary Shares and ordinary-share voting processes.
Can-Fite BioPharma reports positive results from its Phase III COMFORT™ trial for Piclidenoson, a treatment for moderate to severe plaque psoriasis. The primary endpoint was met, with significant improvement observed in patients receiving a 3 mg dosage compared to placebo at week 16 (9.7% vs. 2.6%, P0.04). Piclidenoson demonstrated an excellent safety profile, better than Otezla. Can-Fite plans to approach the FDA and EMA for further studies. The company holds five licensing agreements globally for Piclidenoson.
Can-Fite BioPharma (NYSE American: CANF) has announced that their study on CF602, an allosteric modulator of the A3 adenosine receptor, has been published in the journal Andrologia. The study demonstrates that CF602 effectively reverses erectile dysfunction (ED) in a diabetic rat model, showing potential as an alternative treatment for the estimated 30-35% of ED patients who are non-responders to standard PDE5 inhibitors like Viagra and Cialis. The global ED market is valued at $3.6 billion and projected to grow to $5.94 billion by 2028.
Can-Fite BioPharma (NYSE American: CANF) has published an article on A3 Adenosine Receptor-targeting drugs in MDPI's journal Molecules. The data supports the potential of Piclidenoson and Namodenoson as frontrunners for FDA approval, showcasing their efficacy against psoriasis, liver cancer, and NASH. Can-Fite's extensive clinical data involves over 1,500 patients across multiple trials, with current studies including a Phase III for psoriasis and a Phase IIb for NASH. The company has received regulatory designations for its drug candidates that address significant market needs.
Can-Fite BioPharma Ltd. (NYSE American: CANF) reported its financial results for Q1 2022, with revenues of $0.20 million, up 38.5% from $0.15 million in Q1 2021. The company holds $16.5 million in cash and equivalents. R&D expenses rose 39.8% to $1.82 million due to ongoing clinical trials for psoriasis and NASH treatments. The net loss increased to $2.43 million from $1.87 million year-on-year. Upcoming milestones include Phase III psoriasis study results expected in Q2 2022 and ongoing Phase IIb and III studies for NASH and liver cancer.
Can-Fite BioPharma Ltd. (NYSE American: CANF) has received a patent for its A3 Adenosine Receptor ligand aimed at treating ectopic fat accumulation, particularly in non-alcoholic steatohepatitis (NASH) and fatty liver disease. The patent is recognized in about 40 countries, including Japan and the EU. The market for NASH treatment is expected to reach $35 billion by 2025. Can-Fite is currently conducting a Phase IIb clinical trial for its drug candidate Namodenoson, which previously met key endpoints in Phase IIa trials, showing safety and efficacy in reducing liver fat.
Can-Fite BioPharma (NYSE American: CANF) announced a Phase II study where Namodenoson, an oral drug targeting liver cancer, cleared all lesions in an advanced patient. The pivotal Phase III trial has received FDA and EMA approval and is now open to recruit around 450 hepatocellular carcinoma patients. The drug selectively binds to the A3 adenosine receptor, prevalent in cancer cells. CEO Dr. Pnina Fishman is set to present at the Adenosine Pathway Targeted Cancer Immunotherapy Summit in Boston on May 12, 2022, highlighting the drug's promising results.
Can-Fite BioPharma (NYSE American: CANF) is advancing a topical treatment for psoriasis using its Phase III oral drug candidate, Piclidenoson. Recent preclinical studies show significant efficacy in managing psoriasis symptoms. The global psoriasis drug market, valued at $11.37 billion, is projected to grow at a CAGR of 6.5%. Can-Fite expects to release topline results for its Phase III trial in Q2 2022, with positive interim data supporting the development of its topical formulation as a complement to the oral treatment.
Can-Fite BioPharma Ltd (NYSE American: CANF) announced that CEO Dr. Pnina Fishman will present at the 3rd Annual Dermatology Drug Development Summit on April 6, 2022, showcasing the lead drug candidate Piclidenoson for psoriasis treatment. Enrollment in the Phase III Comfort™ study is complete with 400 patients across 30 sites in Europe, Israel, and Canada, with topline data expected in Q2 2022. The company has received approximately $20 million from licensing agreements, enhancing its market reach in various countries.
Can-Fite BioPharma (NYSE: CANF) announced its financial results for the year ended December 31, 2021, reporting revenues of $0.85 million, up from $0.76 million in 2020. The company had a cash balance of $18.9 million at year-end. Key developments include a significant $42.7 million out-licensing deal with Ewopharma and positive Phase II results for Namodenoson in liver cancer. A Phase III study for liver cancer is set to start in H1 2022, and topline data for psoriasis is expected in Q2 2022.
Can-Fite BioPharma Ltd (NYSE: CANF) announced a Notice of Allowance from the U.S. Patent and Trademark Office for its method to treat advanced liver fibrosis with Namodenoson. This expansion targets various liver conditions including NASH and liver cancer, tapping into a market projected to exceed $20 billion by 2020.
The company is currently enrolling patients for a Phase IIb trial for NASH and plans to begin a Phase III trial for advanced liver cancer. Namodenoson boasts a strong safety profile and significant commercial potential.