RAMAT GAN, Israel - Can-Fite BioPharma (NYSE:CANF) Ltd. (NYSE American: CANF) (TASE:CANF), an Israeli biotech firm, has announced that its drug candidate Namodenoson has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of advanced liver cancer, also known as hepatocellular carcinoma (HCC). The designations aim to facilitate and expedite the drug's development and regulatory review process.
Namodenoson, a small molecule drug, targets the A3 adenosine receptor (A3AR) and has shown a promising safety profile and efficacy in Phase 2 trials, including prolonged survival and quality of life improvements in advanced liver cancer patients. It is now undergoing a Phase 3 pivotal study, known as LIVERATION, which is currently recruiting participants across 31 medical centers in Europe, Israel, and the United States.
The LIVERATION trial will enroll 450 patients diagnosed with advanced liver cancer and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will receive either Namodenoson or a placebo in a 2:1 ratio, with the primary endpoint being overall survival. Additional outcomes such as tumor response rates and median progression-free survival will also be assessed, with an interim analysis planned after half of the enrolled patients have been treated.
Liver cancer is a significant global health concern, with more than 700,000 deaths annually. The market for HCC treatments is expected to grow, with an estimated value of $3.8 billion by 2027 for the G8 countries, according to Delveinsight.
Can-Fite BioPharma is also conducting clinical trials for other indications, including a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH) and a planned Phase IIa study in pancreatic cancer.
The information in this article is based on a press release statement from Can-Fite BioPharma Ltd.
Furthermore, Can-Fite has received a Notice of Allowance from the European Patent Office for its erectile dysfunction (ED) treatment patent, about the CF602 drug candidate.
The company has also expanded its agreement with Ewopharma to include marketing rights for Namodenoson in treating pancreatic carcinoma.
These are recent developments that underscore Can-Fite's continued efforts in drug development and clinical trials. The company's focus on diseases such as NASH, ED, and various cancers, along with the expansion of their agreements and patent allowances, demonstrate its commitment to addressing these health concerns.
InvestingPro Insights
As Can-Fite BioPharma Ltd. advances its drug candidate Namodenoson through the regulatory process, the company's financial metrics and market performance provide additional context for investors. According to InvestingPro data, Can-Fite currently holds a Price to Book ratio of 1.95 as of the last twelve months ending Q4 2023, suggesting a moderate valuation relative to the company's book value. However, the company's revenue reflects a contraction, with a decline of 8.27% in the same period, and a more pronounced quarterly revenue decline of 21.32% in Q4 2023.
Despite the recent FDA designations which may bolster the company's prospects, Can-Fite is experiencing challenges as indicated by an operating income margin of -1102.96% for the last twelve months as of Q4 2023, underscoring the company's significant operational losses relative to its revenue. This is further substantiated by InvestingPro Tips, which highlight that Can-Fite is quickly burning through cash and analysts do not expect the company to be profitable this year.
Investors interested in the potential upside of Can-Fite's clinical developments should consider these financial metrics alongside the company's strategic moves. For further insights and additional InvestingPro Tips, such as the company's cash position relative to debt and its liquid assets coverage for short-term obligations, visit InvestingPro. Currently, there are 7 more InvestingPro Tips available which could provide a deeper understanding of Can-Fite's financial health and market position. To access these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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