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Can-Fite Catapults NASH Indication Into Phase II Aiming for $35 Billion Market

NEW YORK, NY / ACCESSWIRE / July 28, 2016 / Newsweek magazine called NASH “The 21st Century’s Looming Public Health Threat”. Dieting can save people in the early stages, if it’s diagnosed. After that, there’s nothing. A little known yet lethal disease, non-alcoholic steatohepatitis (NASH) is the advanced form of non-alcoholic fatty liver disease (NAFLD) characterized by fat build up in the liver. Rising prevalence and no approved therapy make it an indication aggressively pursued by the pharma industry. Once approved treatments come to market, Deutsche Bank projects their annual sales to be in the $35 – $40 billion range by 2025. While several companies have been pursuing the indication for some years, Can-Fite BioPharma (NYSE MKT: CANF) is jumping into Phase II trials for NASH with its promising liver disease drug candidate CF102.

The beauty of CF102 – it has shown in clinical and preclinical studies to heal and repair numerous key liver functions. Because CF102 is now in a global Phase II study for the treatment of liver cancer, Can-Fite can leverage this into launching its Phase II NASH study in the same countries where it already has clearance to study CF102 in liver cancer.

Diabetes, a recognized epidemic in the U.S. because 29 million people live with the disease, actually pales in comparison to the number of people with NAFLD. An astonishing 67 million people in the U.S. have NAFLD. Anywhere from 5.6 to 8.4 million Americans are living with NASH and .89 to 2.52 million of those will get cirrhosis. In later stages, NASH is known to lead to liver cancer and liver failure.

The public health threat comes in the fact that at current growth rates, there won’t be enough liver donors available to save people needing liver transplant due to NASH. The second largest organ of the body, the liver has an essential role in human health, removing harmful substances from our blood and processing what we eat and drink into energy and nutrients the body can use. NASH is the third leading cause of liver transplants in the U.S. today and is expected to surpass hepatitis C as the leading cause for liver transplants by 2020.

25 million Americans will have NASH by 2025, driven by rising obesity rates. This is huge. To put this into perspective, 3.2 million people in the U.S. have hepatitis C. Based on the dire need, the U.S. FDA is likely to grant Breakthrough and Fast Track Designations to speed up the most promising NASH drugs in development today. The FDA has already granted Breakthrough Therapy Designation for Intercept’s (ICPT) OCA which is in Phase III for NASH.

Can-Fite announced it plans to conduct a 75 patient double blind, placebo controlled, Phase II study at leading medical centers in Israel, following submission of its protocol to review boards at those clinics in the fourth quarter of this year. The study will test CF102’s ability to treat NAFLD using measures including a reduction in liver fat, something CF102 has already proven it can do in preclinical studies.

Other players in the market for NASH include Genfit (GNFTF) for its drug Elafibranor and India-based Zydus Cadila with its drug Lipaglyn, both in U.S. FDA Phase III trials. A handful of other companies are in Phase II. Due to the unmet need and huge market size, a number of other biotechs, and through partnerships, a few big pharma players Sanofi (SNY) and Bristol Myers Squibb (BMY), are angling to advance their NASH drug candidates.

Many different therapies, some used in combination, will likely be needed in the NASH market. Because the causes of NASH are not yet clearly understood, different drugs may be more efficacious in different people. Not all people with NASH are overweight, obese, or have diabetes. The disease is occurring more often than expected in people who have no apparent risk factors.

As an oral tablet, with a superb safety profile, CF102 is a drug candidate to bet on for NASH. Preclinical studies of CF102 have shown efficacy in the treatment of liver regeneration and function following liver surgery. CF102 revealed its capability to improve liver pathology in an animal model of NASH. CF102 also had a statistically significant reduction in NAFLD activity score compared to placebo. Can-Fite’s drug reduced liver-to-body weight compared to placebo and reduced liver fat levels as compared to placebo.

Beyond NASH, CF102 has received Fast Track Designation in the U.S. and Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency in the treatment of liver cancer. Can-Fite has proven its ability to advance forward into Phase III trials. Its lead drug candidate, Piclidenoson, is about to enter Phase III for psoriasis and rheumatoid arthritis. With a portfolio that includes two indications in Phase II and two more in Phase III, all addressing multi-billion markets, at a $30 million market cap, Can-Fite is a bargain.

HC Wainright’s analyst agrees with me. The firm has a buy recommendation on the stock with a price target of $6.00 per share, more than double where it is trading over the past month in the $2.00 – $2.50 range.

RAY DIRKS Research suggests that Readers/Investors place no more than 1% of the funds they devote to common stocks in any one issue. It’s best to diversify.

About Ray Dirks

Ray Dirks came to Wall Street with Goldman, Sachs & Co. in 1963 where he was established as the leading insurance stock analyst dealing with institutional investors and high -net worth investors both in the U.S. and internationally.

In 1973 Ray uncovered the biggest Ponzi scheme of the 20th century, the Equity Funding fraud. Over the years Ray has expanded his stock market research to include Healthcare Stocks and Special Situations. Ray has written two books, “The Great Wall Street Scandal” and “Heads You Win, Tails You Win,” published by McGraw-Hill and Bantam Books respectively. He continues to provide research to institutions and individuals, and he manages money for some individual investors.

Contact:

Jackie Rodriguez
(646)-430-5783

SOURCE: RAY DIRKS Research

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