PETACH TIKVA, Israel - Can-Fite BioPharma (NYSE:CANF) Ltd. (NYSE American: CANF) (TASE: CANF), an Israeli biotechnology firm, has reached a new milestone in the development of its drug candidate Namodenoson, currently undergoing a pivotal Phase III trial for advanced liver cancer. The trial, named LiverationTM, has received approval from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Namodenoson, which also targets metabolic dysfunction-associated steatohepatitis (MASH), is designed to selectively bind to the A3 adenosine receptor (A3AR), a protein that is highly expressed in diseased cells but less so in healthy ones. This selective binding is believed to contribute to the drug's dual anti-cancer and liver-protective effects. The company has reported encouraging clinical data from earlier Phase II studies in hepatocellular carcinoma (HCC) and a Phase IIa study in MASH.
The drug's dual mechanism of action, which involves the inhibition of inflammatory cytokines and the stimulation of positive cytokines, has been detailed in an article published by the journal Biomedicines. Dr. Ohad Etzion, a key opinion leader in hepatology and the first author of the study, has expressed optimism about the drug's safety profile and its potential as a treatment for liver diseases.
In addition to the ongoing Phase III trial for HCC and a Phase IIb study for MASH, Can-Fite has plans for a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe, as well as Fast Track Designation by the FDA for second-line treatment of HCC. The drug has also shown promise in treating other cancers, including colon, prostate, and melanoma.
Can-Fite BioPharma has a broader pipeline, with its lead drug candidate Piclidenoson recently completing a Phase III trial for psoriasis and preparing for another pivotal Phase III trial. Another drug candidate, CF602, has demonstrated efficacy in treating erectile dysfunction.
This information is based on a press release statement from Can-Fite BioPharma Ltd.
InvestingPro Insights
Can-Fite BioPharma Ltd. (NYSE American: CANF) has been actively developing its drug candidate Namodenoson with recent milestones suggesting potential in treating advanced liver cancer. As investors consider the implications of these developments, certain financial metrics and expert insights can provide a more comprehensive view of the company's position.
According to real-time data from InvestingPro, Can-Fite BioPharma exhibits a Price to Book (P/B) ratio of 1.75, reflecting the market's valuation of the company relative to its book value. This metric can be particularly insightful when assessing the value investors are attributing to the company's assets, minus liabilities. The company's Revenue Growth has seen a decline of 8.27% over the last twelve months as of Q1 2023, signaling challenges in increasing sales. Additionally, the Operating Income Margin stands at -1102.96%, indicating the company's current expenses far exceed its gross profit.
Among the InvestingPro Tips, two are particularly noteworthy in light of the article's context. Firstly, Can-Fite is said to be quickly burning through cash, which is a critical factor to consider given the expensive nature of clinical trials and drug development. Secondly, analysts do not anticipate the company will be profitable this year, which aligns with the reported operating income margin and could impact investor confidence. These insights suggest that while the clinical advancements are promising, the financial health of Can-Fite requires careful consideration.
For investors seeking a more in-depth analysis, there are additional InvestingPro Tips available, which can be accessed at: https://www.investing.com/pro/CANF. These tips delve into various aspects of Can-Fite's financial and market performance, offering investors a broader perspective on the company's potential risks and opportunities. To further enrich your investment strategy, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking even more expert insights and data-driven analysis.
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