Can Fite Biopharma Ltd (ADR) (NYSEMKT:CANF), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Company’s drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA’s Orphan Drug designation.
Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar® (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.
Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug’s development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.
“We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication,” stated Can-Fite CEO Dr. Pnina Fishman. “We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients.”
According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014. (Original Source)
Shares of Can-Fite BioPharma Ltd closed yesterday at $1.68. CANF has a 1-year high of $5.83 and a 1-year low of $1.46. The stock’s 50-day moving average is $1.77 and its 200-day moving average is $2.49.
On the ratings front, Can-Fite has been the subject of a number of recent research reports. In a report issued on August 31, H.C. Wainwright analyst Mark Breidenbach reiterated a Buy rating on CANF, with a price target of $4, which represents a potential upside of 138.1% from where the stock is currently trading. Separately, on May 31, Roth Capital’s Joseph Pantginis maintained a Hold rating on the stock and has a price target of $3.30.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Mark Breidenbach and Joseph Pantginis have a total average return of -14.0% and -0.7% respectively. Breidenbach has a success rate of 44.4% and is ranked #3403 out of 3765 analysts, while Pantginis has a success rate of 40.5% and is ranked #3049.
Can Fite Biofarma Ltd isa clinical stage biopharmaceutical company that develops orally bioavailable small molecule therapeutic products for the treatment of autoimmune-inflammatory, oncological and ophthalmic diseases.