Can-Fite BioPharma
🇮🇱Israel
- Country
- 🇮🇱Israel
- Ownership
- Public
- Established
- 1994-01-01
- Employees
- 5
- Market Cap
- $12.2M
- Website
- http://www.canfite.com
- Introduction
Can-Fite BioPharma Ltd. is a biopharmaceutical company, which engages in the development of drugs for the treatment of cancer, liver and inflammatory diseases and erectile dysfunction. Its product pipeline include Piclidenoson, Namodenoson, and CF602. The company was founded by Pnina Fishman and Ilan Cohn on September 11, 1994 and is headquartered in Petach-Tikva, Israel.
Can-Fite BioPharma Secures $3 Million in Funding to Advance Clinical Trials for Oncology and Inflammatory Disease Treatments
• Can-Fite BioPharma has secured $3 million through a registered direct offering of 2.5 million American Depositary Shares priced at $1.20 per ADS, with the transaction expected to close by April 15, 2025.
• The biotech company plans to allocate the proceeds toward advancing its pipeline of small-molecule drugs, including Piclidenoson for psoriasis, Namodenoson for liver cancer and MASH, and CF602 for erectile dysfunction.
• Namodenoson has received Orphan Drug Designation in both the U.S. and Europe, as well as Fast Track Designation from the FDA as a second-line treatment for hepatocellular carcinoma.
Robust Pipeline of 80+ Therapies Advancing in Psoriasis Treatment Landscape
• DelveInsight's 2025 Psoriasis Pipeline Report reveals over 80 companies developing 80+ pipeline therapies, highlighting significant R&D investment in this therapeutic area.
• Promising treatments in development include topical roflumilast (Arcutis Biotherapeutics) in Phase III trials and GSK2982772 (GlaxoSmithKline), a novel RIPK1 inhibitor in Phase I development.
• Alumis Inc. has initiated a long-term extension study for ESK-001 in moderate to severe plaque psoriasis patients, evaluating safety, efficacy, and durability of response over 24 weeks.
Can-Fite Launches FDA & EMA-Approved Phase 3 Trial for Oral Psoriasis Drug Piclidenoson
• Can-Fite BioPharma has initiated a pivotal Phase 3 clinical trial for Piclidenoson, an oral drug targeting moderate to severe plaque psoriasis, with protocols approved by both FDA and EMA regulatory authorities.
• The randomized, double-blind study will evaluate 3mg twice-daily oral dosing, measuring efficacy through PASI 75 scores and Static Physician's Global Assessment at Week 16, with patient enrollment beginning in Europe before expanding to North America.
• Piclidenoson works by inhibiting inflammatory cytokines IL-17 and IL-23 while inducing apoptosis in affected skin cells, positioning it as a potential key player in the psoriasis market projected to reach $30 billion by 2030.
Can-Fite Advances Piclidenoson to Phase II Trial for Rare Lowe Syndrome with No Current Treatments
• Can-Fite BioPharma has completed the design of a Phase II clinical trial for Piclidenoson in Lowe Syndrome, a rare genetic disease affecting approximately 1 in 500,000 people with no approved treatments.
• The open-label study will enroll five patients who will receive 3mg of Piclidenoson twice daily for 12 months, with the primary endpoint measuring improvements in renal uptake.
• The development follows successful preclinical research by Dr. Antonella De Matteis, who found Piclidenoson significantly decreased urinary protein loss in Lowe Syndrome models after testing thousands of compounds.
NASH Pipeline Shows Promise with 80+ Emerging Therapies in Development
• Over 80 companies are actively developing treatments for Non-Alcoholic Steatohepatitis (NASH), with Inventiva Pharma and Cirius Therapeutics leading with Phase III candidates lanifibranor and MSDC-0602K respectively.
• Lanifibranor, a triple PPAR agonist with FDA Breakthrough Therapy designation, demonstrates significant anti-inflammatory and antifibrotic properties, while MSDC-0602K selectively modulates the mitochondrial pyruvate carrier to improve metabolic parameters.
• Novel therapeutic approaches include Terns Pharmaceuticals' THR-β agonist TERN-501 and HighTide Biopharma's HTD1801, both showing promising results in reducing liver fat and improving metabolic markers in Phase II trials.
Namodenoson Shows Promise in Treating Decompensated Liver Cirrhosis: Patient's Remarkable Recovery in Compassionate Use Program
• A patient with decompensated liver cirrhosis demonstrated significant clinical improvement after 20 months of Namodenoson treatment, including resolution of moderate ascites and no further variceal bleeding episodes.
• Can-Fite BioPharma's Namodenoson emerges as a potential breakthrough for decompensated cirrhosis patients, addressing a critical gap in treatment options beyond liver transplantation.
• The development holds significant promise for the estimated 10.6 million people globally affected by decompensated cirrhosis, targeting a U.S. market projected to reach $15 billion by 2030.
Advanced Liver Cancer Market to Reach $11.13 Billion by 2035, Driven by Early Detection and Novel Therapies
• The advanced liver cancer market is projected to grow from $2.31 billion in 2024 to $11.13 billion by 2035, exhibiting a CAGR of 15.38%, according to IMARC Group research.
• Advancements in early detection technologies, including multi-modal MRI, contrast-enhanced ultrasound, and liquid biopsy, are significantly improving diagnosis and expanding treatment options for patients.
• Novel therapeutic approaches, including targeted therapies, immunotherapies, and combination treatments, are transforming patient outcomes, with drugs like Namodenoson showing promising results in clinical trials.
Can-Fite's Namodenoson Shows Liver Protection and Anti-Cancer Activity in HCC
• Can-Fite BioPharma's Namodenoson demonstrates liver-protective effects alongside its anti-cancer activity in hepatocellular carcinoma (HCC).
• A Phase 3 trial is underway for Namodenoson in advanced liver cancer, with promising results including one patient cancer-free for over 8 years.
• The drug's unique mechanism involves adiponectin, offering potential cardio- and neuro-protective benefits in addition to liver protection.
• Namodenoson's liver-protective properties differentiate it from other HCC treatments that can induce liver toxicity, according to Can-Fite.
Can-Fite Doses First Patient in Phase IIa Pancreatic Cancer Trial with Namodenoson
• Can-Fite BioPharma has dosed the first patient in its Phase IIa clinical trial evaluating Namodenoson for advanced pancreatic adenocarcinoma.
• The open-label, multicenter trial will assess the safety, clinical activity, and pharmacokinetics of oral Namodenoson (25 mg twice daily) in patients who have progressed on first-line therapy.
• The primary objective is to characterize the safety profile of Namodenoson, while secondary objectives include evaluating clinical activity via ORR, PFS, DCR, DoR, and OS.
• Namodenoson, an orally bioavailable A3 adenosine receptor agonist, has received Orphan Drug Designation from the FDA for this indication.
Can-Fite BioPharma Doses First Patient in Phase IIa Pancreatic Cancer Trial with Namodenoson
• Can-Fite BioPharma has dosed the first patient in its Phase IIa clinical trial (NCT06387342) evaluating Namodenoson for advanced pancreatic adenocarcinoma.
• The open-label, multicenter trial will assess the safety, clinical activity, and pharmacokinetics of oral Namodenoson (25 mg twice daily) in patients who have progressed on first-line therapy.
• The primary objective is to characterize the safety profile of Namodenoson, while secondary objectives include evaluating ORR, PFS, DCR, DoR, and OS.
• Namodenoson has received Orphan Drug Designation from the U.S. FDA for pancreatic cancer, highlighting the unmet need for effective treatments.
Can-Fite BioPharma Doses First Patient in Phase IIa Pancreatic Cancer Trial of Namodenoson
• Can-Fite BioPharma initiates Phase IIa trial of Namodenoson for advanced pancreatic adenocarcinoma, marking a key step in addressing unmet treatment needs.
• The open-label, multicenter trial will assess the safety and clinical activity of oral Namodenoson (25mg twice daily) in patients who have progressed on first-line therapy.
• The study will evaluate key endpoints including Objective Response Rate, Progression-Free Survival, and Overall Survival to determine Namodenoson's efficacy.
• Namodenoson recently received Orphan Drug Designation from the FDA, potentially granting Can-Fite seven years of market exclusivity upon approval.
Can-Fite Doses First Patient in Phase IIa Pancreatic Cancer Trial with Namodenoson
• Can-Fite BioPharma has dosed the first patient in a Phase IIa clinical trial evaluating Namodenoson for advanced pancreatic adenocarcinoma.
• The open-label, multicenter trial will assess the safety, clinical activity, and pharmacokinetics of oral Namodenoson in patients who have progressed on first-line therapy.
• The primary objective is to characterize the safety profile of Namodenoson, while secondary objectives include evaluating Objective Response Rate (ORR), Progression-Free Survival (PFS), and Overall Survival (OS).
• Namodenoson, an orally bioavailable A3 adenosine receptor agonist, has received Orphan Drug Designation from the FDA for this indication.
Can-Fite's Namodenoson Receives Patent Allowance in Australia and US for Anti-Obesity Use
• Can-Fite BioPharma's Namodenoson receives patent allowance in Australia and the US for treating obesity, expiring in 2040 and 2042, respectively.
• The patent covers methods of treating obese patients using an oral formulation of Namodenoson, an A3 adenosine receptor ligand.
• Clinical data shows Namodenoson reduces fat levels by increasing adiponectin and inducing weight loss in animal models and MASH patients.
• Namodenoson is currently in Phase IIb trials for MASH, with potential to address the growing global obesity treatment market, projected to reach $60.5 billion by 2030.
Can-Fite BioPharma Advances Clinical Trials for Psoriasis, HCC, and NASH
• Can-Fite BioPharma focuses on orally bioavailable small molecule therapeutics for cancer, liver, and inflammatory diseases.
• Piclidenoson is in Phase III clinical trials for psoriasis, showing promise in treating this chronic skin condition.
• Namodenoson is progressing through Phase III trials for hepatocellular carcinoma (HCC) and Phase IIb for non-alcoholic steatohepatitis (NASH).
• The company's A3 adenosine receptor (A3AR) targeted platform offers innovative solutions with improved patient compliance via oral administration.
Namodenoson Receives FDA Orphan Drug Designation for Pancreatic Cancer
• Namodenoson, a drug developed by Can-Fite BioPharma, has been granted Orphan Drug Designation by the FDA for pancreatic cancer treatment.
• The designation offers Can-Fite potential market exclusivity for seven years post-approval, along with regulatory advantages and tax credits.
• A phase 2 study is planned to assess the safety, clinical activity, and pharmacokinetics of namodenoson in patients with advanced pancreatic cancer.
• Preclinical studies indicate that namodenoson inhibits pancreatic cancer cell growth and modulates key signaling pathways, supporting its continued evaluation.
Hepatocellular Carcinoma: Over 90 Companies Pursue Novel Therapies
• Over 90 pharmaceutical and biotech companies are actively developing more than 95 pipeline drugs for hepatocellular carcinoma (HCC).
• Key companies like Can-Fite BioPharma are advancing HCC drug candidates, with some therapies in Phase III clinical trials.
• Emerging therapies such as Namodenoson, SRF388, and Porustobart are expected to significantly impact the HCC market in the coming years.
• The pipeline includes diverse routes of administration and molecule types, offering varied treatment options for HCC.
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