Can-FITE BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, today announced the successful completion of long-term pre-clinical toxicity studies regarding its flagship drug, CF101. The tests were conducted by United States Food and Drug Administration standards, Can-FITE says.

That doesn't mean that the FDA examined Can-FITE's results: that is the job of panels of experts. But the FDA does receive copies.

The significance of the development is that patients can take CF101 for long-term six-month or 12-month clinical trials of the drug, which is usually required in Phase III clinical trials.

Can-FITE is developing CF101 to treat psoriasis, an incurable skin condition, which is shown in the form of scaly, discolored skin plaques. The disease affects 2%-3% of the general population and its global market is currently estimated at about $3 billion per annum, the company says.

It is also developing CF101 to treat rheumatoid arthritis and dry eye syndrome.

On January 14, 2007, Can-FITE said it had recruited 250 patients with gout, for Phase IIb clinical trials of CF101, in Europe, the United States and Israel. The patients were given the drug for 12 weeks. It will be releasing the results of the trial in the summer.

Can-FITE has also received regulatory approval to commence Phase II clinical trials of CF101 for psoriasis. This trial will involve about 60 patients, treated for about 12 weeks at four medical centers in Israel. The company thinks it can complete the trial will be completed in the first quarter of 2008.

Can-FITE chief executive Prof. Pnina Fishman commented today that success in the toxicity tests is a significant step in the development of the drug. Now the company can proceed onto the next development phases, she said, and treat patients for longer periods of time. 

"That fact will enable deeper study of the beneficial effect CF101 has on the various inflammatory diseases it is designed to treat," she said.

Can-FITE BioPharma, founded  by Prof. Fishman and patent lawyer Dr. Ilan Cohn, commenced operations in 2000 and subsequently floated on the Tel Aviv Stock Exchange. The company is focusing on the development of drugs that delay the proliferation of cancerous or otherwise diseased cells.