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Can-Fite Wins FDA Nod for Phase III Trial

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Saturday, September 11th, 2010

As reported in Globes: CEO Prof. Pnina Fishman: The treatment positions the company in the forefront of drug development for dry-eye syndrome.

Can-Fite BioPharma Ltd.  has obtained US Food and Drug Administration (FDA) approval for the Phase III clinical trial of its CF101 anti-inflammatory drug for the treatment of dry-eye syndrome. The trial will last for six months, and include 300 patients in the US, Europe and Israel.

Can-Fite added, however, that to register the drug for use, two Phase III trials, with 500 patients altogether, will be needed.

Can-Fite noted that it had successfully completed a Phase II clinical trial of CF101 for dry-eye syndrome, which demonstrated with statistical significance that the drug was effective and safe.

Can-Fite CEO Prof. Pnina Fishman said, “Can-Fite today took another important step forward in the development of its first innovative drug. The FDA’s approval strengthens recognition of the company and the potential of CF101. The treatment positions the company in the forefront of drug development for dry-eye syndrome. Assuming that the Phase III trial succeeds as did the previous trial, CF101 will be an effective treatment for a disease with a currently estimated market of $2 billion.”

Can-Fite’s updated estimates said that more than 30 million people in the US alone suffer from dry-eye syndrome.

Can-Fite’s share price rose 6.1% in morning trading to NIS 0.53, giving a market cap of NIS 110 million.