New business will continue late-stage development of CF101 in dry eye syndrome, glaucoma, and uveitis.

Israel firm Can-Fite BioPharma is spinning out the ophthalmic indications for its lead drug candidate, CF101, to a subsidiary fully owned by the U.S.-based public company Denali Concrete Management. As part of the deal Can-Fite will become a majority shareholder of Denali and invest at least $5 million in the firm. Can-Fite is focused on developing drugs that target the A3 adenosine receptor (A3AR).

CF101 is the firm’s lead A3AR agonist candidate. It has demonstrated efficacy in Phase II trials as a treatment for psoriasis, dry eye syndrome, and rheumatoid arthritis. An FDA-approved Phase III dry eye syndrome study and Phase II/III dry eye syndrome trial are also under way.

The firm says establishing a new ophthalmic-focused business will expedite development of CF101 for indications including dry eye syndrome, glaucoma, and uveitis. The firm separately has licensed CF101 to Seikagaku for the treatment of autoimmune diseases in Japan, and to Kwang Dong in Korea.

Can-Fite’s second lead candidate, CF102, is another A3AR agonist, currently undergoing Phase I/II development both for the treatment of hepatocellular carcinoma and HCV infection. Just last month the firm reported positive interim data from an ongoing Phase I/II study evaluating CF102 in 18 HCC patients, most of whom had failed prior treatment with sorafenib (Nexavar).

The interim results suggest a favorable safety profile for CF102 in primary liver cancer and Child-Pugh cirrhosis classes A and B. The median overall survival time was as high as 8.1 months, an encouraging statistic given that most patients were being treated in a second-line setting and some were Child-Pugh class B, the firm notes.

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