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Can-Fite to Initiate Phase II Study in the Rare Genetic Disease Lowe Syndrome with Piclidenoson
Globenewswire· 2025-03-19 13:00
Core Viewpoint - Can-Fite BioPharma Ltd. is advancing its clinical study for Piclidenoson, targeting the rare genetic disease Lowe Syndrome, with a Phase II trial set to begin soon [1][3]. Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases [1][11]. - The company’s lead drug candidate, Piclidenoson, is currently in pivotal Phase III trials for psoriasis and has shown efficacy in preclinical studies for Lowe Syndrome [6][11]. Clinical Study Details - The Phase II study for Lowe Syndrome will enroll 5 patients, who will receive 3 mg of Piclidenoson twice daily for 12 months, with the primary endpoint being the efficacy in increasing renal uptake [2][3]. - The study is led by Dr. Franchesca Emma from Bambino Gesù Children's Hospital in Rome, Italy [2]. Disease Background - Lowe Syndrome, an X-linked genetic condition, primarily affects males and is characterized by vision problems, kidney issues, and intellectual disabilities, with a prevalence of approximately 1 in 500,000 [4][5]. - There are currently no available drugs for Lowe Syndrome, highlighting the medical need for effective treatments [3][4]. Research Collaboration - Can-Fite has partnered with Fondazione Telethon for the clinical development of Piclidenoson, leveraging their expertise in rare genetic diseases [3][8]. Piclidenoson Overview - Piclidenoson is a first-in-class A3 adenosine receptor agonist with a strong safety profile and evidence of efficacy in both Phase II and Phase III studies [7][11]. - The drug works by inhibiting inflammatory cytokines IL-17 and IL-23 and inducing apoptosis in skin cell keratinocytes [7]. Fondazione Telethon Contributions - Fondazione Telethon has invested over 660 million euros in research, funding nearly 3,000 projects and studying 630 diseases, aiming to develop therapies for rare genetic conditions [9][10].
Can-Fite: FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient
Newsfilter· 2025-03-18 12:30
Core Insights - Can-Fite BioPharma Ltd. has received FDA approval for compassionate use of its anti-cancer drug Namodenoson for a pancreatic cancer patient in the U.S. [1][3] - Namodenoson is currently undergoing multiple clinical trials, including a pivotal Phase III study for advanced liver cancer and a Phase IIa study for pancreatic cancer [3][5] - The drug has been granted Orphan Drug Designation by the FDA for pancreatic cancer, which may provide market exclusivity for seven years post-approval [4][6] Company Overview - Can-Fite BioPharma is a clinical-stage biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases [1][6] - The company’s lead drug candidate, Piclidenoson, has recently reported positive results in a Phase III trial for psoriasis [6] - Namodenoson has shown potential efficacy in treating various cancers, including colon, prostate, and melanoma, and has an excellent safety profile based on clinical studies involving over 1,600 patients [5][6]
Can-Fite Innovative Publication: Namodenoson in Liver Cancer Treatment Alongside with Cardiac, Liver, and Neurological Benefits
Newsfilter· 2025-03-03 11:00
Core Insights - Can-Fite BioPharma Ltd. announced the publication of a study on Namodenoson, highlighting its protective effects against toxicity compared to traditional chemotherapy [1][2][3] - The study demonstrates Namodenoson's anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity effects across multiple body systems, particularly the liver, central nervous system, and cardiovascular system [2][3] - Namodenoson is currently undergoing pivotal Phase III trials for advanced liver cancer, with Orphan Drug and Fast Track designations from the FDA and EMA [4][5] Company Overview - Can-Fite BioPharma is focused on developing small molecule drugs for oncological and inflammatory diseases, targeting multi-billion-dollar markets [6] - The company’s lead drug candidate, Piclidenoson, has shown promising results in a Phase III trial for psoriasis and is expected to enter another pivotal Phase III trial [6] - Namodenoson has shown potential in treating various cancers, including hepatocellular carcinoma, metabolic dysfunction-associated steatohepatitis, and pancreatic cancer, with a strong safety profile demonstrated in over 1,600 patients [5][6]
Disappearance of Decompensated Liver Cirrhosis Episodes After Treatment with Can-Fite's Namodenoson
Newsfilter· 2025-02-18 12:00
Core Insights - The U.S. liver cirrhosis treatment market is projected to reach approximately $15 billion by 2030, highlighting significant growth potential in this sector [3]. Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases, with its lead drug candidate Namodenoson showing promise in treating decompensated liver cirrhosis [1][5]. - Namodenoson is currently undergoing multiple clinical trials, including a pivotal Phase III trial for advanced liver cancer and a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH) [4][5]. Clinical Development - A patient treated with Namodenoson under a compassionate use program has shown significant improvements, including the resolution of moderate ascites and a decrease in liver stiffness, indicating the drug's potential effectiveness [2][3]. - The positive response to Namodenoson is particularly noteworthy given the limited treatment options for decompensated liver disease, which often leads to liver transplantation [3]. Market Need - In 2017, approximately 10.6 million people globally were affected by decompensated cirrhosis, underscoring the urgent need for new therapeutic options as many patients face long wait times for liver transplants [3]. - The American Liver Foundation has indicated a critical shortage of donor organs, with some patients waiting over five years for a transplant, further emphasizing the market opportunity for effective treatments like Namodenoson [3].
Disappearance of Decompensated Liver Cirrhosis Episodes After Treatment with Can-Fite's Namodenoson
Globenewswire· 2025-02-18 12:00
Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [5] - The company is currently advancing its lead drug candidate, Namodenoson, which is being evaluated in multiple clinical trials for liver and other cancers [5] Clinical Development - Namodenoson has shown promising results in treating decompensated liver cirrhosis, with a patient experiencing significant symptom improvement after 20 months of treatment [2][3] - The treatment led to the disappearance of episodes of decompensated liver cirrhosis and improvements in liver stiffness and elevated globulin levels, markers of advanced liver disease [2][3] Market Potential - The U.S. market for liver cirrhosis treatment is projected to grow to approximately $15 billion by 2030, highlighting the urgent need for effective therapies [3] - In 2017, an estimated 10.6 million people globally were affected by decompensated cirrhosis, indicating a significant patient population in need of treatment options [3] Drug Profile - Namodenoson is an orally bioavailable drug that selectively binds to the A3 adenosine receptor, which is highly expressed in diseased cells, contributing to its favorable safety profile [4] - The drug has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for hepatocellular carcinoma by the FDA [5]
Join Can-Fite's Exclusive Live Investor Webinar and Q&A Session on February 25
GlobeNewswire News Room· 2025-02-10 12:10
Core Insights - Can-Fite BioPharma Ltd. is hosting a webinar on February 25, 2025, to discuss its development pipeline and milestones [1][2] - The company has multiple out-licensing deals and potential regulatory and sales milestone payments exceeding $130 million, with $20 million already received [2] - Can-Fite's advanced-stage assets target unmet medical needs in markets valued over $70 billion, positioning the company for potential commercialization [2] Company Overview - Can-Fite BioPharma Ltd. is focused on developing small molecule drugs for oncological and inflammatory diseases, with a lead drug candidate, Piclidenoson, recently reporting Phase III trial results for psoriasis [4] - The company is also evaluating Namodenoson in various trials, including a Phase IIb for Metabolic Dysfunction-associated Steatohepatitis (MASH) and a Phase III for hepatocellular carcinoma (HCC) [4] - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for HCC treatment [4] - CF602, another drug candidate, has shown efficacy in treating erectile dysfunction, with all drugs demonstrating a strong safety profile in over 1,600 patients [4]
Join Can-Fite's Exclusive Live Investor Webinar and Q&A Session on February 25
Newsfilter· 2025-02-10 12:10
Core Insights - Can-Fite BioPharma Ltd. is hosting a webinar on February 25, 2025, to discuss its development pipeline and milestones [1][2] - The company has multiple out-licensing deals and potential regulatory and sales milestone payments exceeding $130 million, with $20 million already received [2] - Can-Fite's advanced-stage assets target unmet medical needs in markets valued over $70 billion, positioning the company for potential commercialization [2] Company Overview - Can-Fite BioPharma Ltd. is focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [1][4] - The lead drug candidate, Piclidenoson, has reported positive Phase III trial results for psoriasis and is set to begin a pivotal Phase III trial [4] - Namodenoson, another key drug, is in various stages of clinical trials for conditions such as Metabolic Dysfunction-associated Steatohepatitis (MASH) and hepatocellular carcinoma (HCC) [4] - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for HCC treatment [4] - CF602, a third drug candidate, has shown efficacy in treating erectile dysfunction [4] Financial Highlights - Can-Fite has secured $20 million in upfront and milestone payments, indicating strong potential for its therapies [2] - The company is strategically positioned to capitalize on a market with a combined value exceeding $70 billion [2]
Can-Fite BioPharma to Present the Namodenoson Anti-Obesity Effect at BIO CEO & Investor Conference 2025
Globenewswire· 2025-02-05 12:00
Core Insights - Can-Fite BioPharma Ltd. is set to present at the BIO CEO & Investor Conference on February 10-11, 2025, in New York City, focusing on its business strategy and clinical milestones [1][2]. Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company specializing in small molecule drugs for oncological and inflammatory diseases, targeting multi-billion-dollar markets [4]. - The company’s lead drug candidate, Namodenoson, is currently in a pivotal Phase III trial for advanced liver cancer and a Phase IIb study for Metabolic Dysfunction-associated Steatohepatitis (MASH) [3][4]. - Another key drug candidate, Piclidenoson, is preparing to enter a pivotal Phase III trial for psoriasis [3][4]. - Can-Fite's third drug candidate, CF602, has shown efficacy in treating erectile dysfunction [4]. Clinical Development - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for HCC treatment by the U.S. FDA [4]. - The company has reported positive topline results for Piclidenoson in a Phase III trial for psoriasis and is expected to advance further [4]. - Can-Fite has conducted clinical studies involving over 1,600 patients, demonstrating an excellent safety profile for its drug candidates [4]. Presentation Details - The presentation at the BIO CEO & Investor Conference will be led by Motti Farbstein, the Chief Executive & Chief Financial Officer, on February 10, 2025, at 3:45 pm EST [6]. - The management team will hold one-on-one meetings with investors and potential partners to discuss the company's future development plans [2].
US Patent Office Granted Can-Fite Namodenoson Patent for Use as anti-Obesity Drug
Newsfilter· 2025-01-27 12:00
Namodenoson Drug Development - Namodenoson, a small orally bioavailable drug, has been granted a US patent for its use as an anti-obesity drug, valid until 2042 [1][2] - The drug is currently being developed for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), advanced liver cancer, and pancreatic cancer [1][6] - In clinical studies, Namodenoson demonstrated a favorable safety profile and a 2.3% weight loss in patients after 3 months, with increased serum adiponectin levels [1][3] Anti-Obesity Mechanism and Market Potential - Namodenoson reduces fat levels by increasing adiponectin, a hormone that regulates fat production, and has shown weight loss in animal models of obesity [3] - The global obesity treatment industry is projected to reach $60.5 billion by 2030, with a compound annual growth rate of 22.3% from 2025 to 2030 [5] Can-Fite BioPharma Overview - Can-Fite BioPharma is an advanced clinical-stage drug development company focusing on cancer, liver, and inflammatory diseases [8] - The company's platform technology targets multi-billion dollar markets, with Namodenoson being a key drug candidate in Phase III trials for liver cancer and Phase IIb trials for MASH [6][8] - Namodenoson has received Orphan Drug Designation in the US and Europe and Fast Track Designation for hepatocellular carcinoma (HCC) treatment [8]
CanFite Biopharma (CANF) Upgraded to Strong Buy: Here's What You Should Know
ZACKS· 2025-01-09 18:01
Can-Fite Biopharma Ltd (CANF) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by th ...