Can-Fite Granted European Patent for CF602 Erectile Dysfunction Treatment

PETACH TIKVA, Israel—Can-Fite BioPharma Ltd. has achieved a significant milestone with the European Patent Office's Notice of Allowance for its patent application concerning the CF602 drug candidate. This innovation involves the use of A3 Adenosine Receptor Ligands in treating sexual dysfunction, particularly erectile dysfunction (ED) in patients who struggle with current market drugs, such as diabetics.

The standard treatment for erectile dysfunction typically involves oral phosphodiesterase type 5 (PDE5) inhibitors—Viagra, Cialis, Levitra, and Stendra. However, a considerable portion of the population, about 30% to 35% of ED patients, do not respond to these treatments. Additionally, these drugs may not be suitable for individuals with diabetes.

Can-Fite's research, recently detailed in the journal Andrologia, proposed CF602 as a viable alternative. In preclinical studies involving diabetic rat models, a single dose of CF602 resulted in full erectile recovery. This was evidenced by improvements in muscle collagen ratio and endothelial cell function. Furthermore, the application of CF602, whether orally or topically, led to enhanced arterial blood flow, increased intracavernosal pressure, improved smooth muscle/collagen ratio, and elevated levels of vascular endothelial growth factor and endothelial nitric oxide synthase.

Motti Farbstein, CEO of Can-Fite, emphasized the strategic value of this European patent, noting that it fortifies the company's intellectual property portfolio related to CF602. He highlighted the promising pre-clinical data, suggesting that CF602 holds substantial potential for further development in treating sexual dysfunction.

The market for erectile dysfunction treatments is projected to grow significantly, reaching approximately $6.6 billion by 2030, according to Market Research Future.

Namodenoson, another drug developed by Can-Fite, is under evaluation in various clinical trials. This orally bioavailable drug binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently in a pivotal Phase III trial for advanced liver cancer and a Phase IIb trial for steatotic liver disease (SLD). Additionally, a Phase IIa study for pancreatic cancer is in the planning stages. The drug's differential expression in diseased versus normal cells may contribute to its excellent safety profile.

Can-Fite BioPharma Ltd. is a clinical-stage drug development company focusing on treatments for cancer, liver, and inflammatory diseases. Its leading drug candidate, Piclidenoson, has shown promise in a Phase III trial for psoriasis and is moving toward another pivotal Phase III trial. Namodenoson, besides its trials for liver diseases, has also received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for second-line treatment of hepatocellular carcinoma (HCC) by the U.S. FDA. This drug has also indicated potential in treating various cancers, including colon, prostate, and melanoma. CF602, the third drug candidate, has demonstrated effectiveness in treating erectile dysfunction. These drugs have been tested in over 1,600 patients, showcasing an excellent safety profile in clinical studies to date.