Bearish interpreters of the interim Phase II/III data Can-Fite ($CANF) presented in 2012 have been proven right. Final top-line results from the trial of CF101 in psoriasis patients showed it failed to meet its primary endpoint, sending shares in the Israeli biotech down 60% to close at a new low for the company.
The data represent a major blow to Can-Fite and CF101, the oral small molecule A3 adenosine receptor (A3AR) agonist it is developing as a treatment for psoriasis, rheumatoid arthritis and glaucoma. In a trial of 326 patients across the U.S., Europe and Israel, CF101 failed to outperform the placebo. After 12 weeks, 8.5% of the treatment arm showed a 75% or more improvement over the baseline on the Psoriasis Area and Severity Index. Almost 7% of the placebo arm showed the same level of improvement.
Data gathered using the Physicians' Global Assessment score--a secondary endpoint in the trial--were equally underwhelming. Can-Fite CEO Pnina Fishman dangled the possibility of a secondary endpoint and sub-group analysis yielding something positive in front of investors, but the hopes of the biotech and anyone hoping to make a buck out of it have most likely moved on to other drugs and indications. Data from an 88-person Phase II glaucoma trial of CF101 are due later this year. And Can-Fite wrapped up the design-stage of a Phase III rheumatoid arthritis trial of the same drug at the end of 2014.
The psoriasis flop puts a question mark against both programs, which are the most advanced at the company. Beyond the three indications being pursued for CF101, Can-Fite has another A3AR agonist--CF102--in development as a liver cancer treatment. The company dosed the first patient in a Phase II trial of CF102--which is designated an orphan drug by FDA--late last year. Enrollment in the 78-person trial is expected to close in the fourth quarter.
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