Can-Fite BioPharma Ltd (PETACH TIKVA, Israel), a clinical-stage drug development company focused on a portfolio of orally bioavailable, highly selective, small molecule adenosine receptor (A(3)AR) agonists with potent activities in inflammation and cancer, announced that Seikagaku Corp, the exclusive licensee of Can-Fite’s CF101 in the Japanese market and a pioneer in the field of glycoscience and therapeutics for joint diseases, will commence a phase I clinical trial in Japan with CF101 to treat rheumatoid arthritis (RA). Under the 2006 agreement terms, which allows Seikagaku to develop, manufacture, and market CF101 in Japan for the treatment of inflammatory diseases (excluding ophthalmology indications), Can-Fite will receive a consideration of $1 million USD upon clinical trial initiation. Since the agreement between the two companies was signed, Seikagaku has been conducting preclinical studies.

CF101, Can-Fite’s lead compound, is an oral drug that has been successfully used in animal models and human phase IIa RA trials to test the concept of targeting A(3)AR for the treatment of inflammatory diseases. Phase I studies in healthy volunteers as well as the phase IIa clinical studies in RA patients have demonstrated the drug’s safety profile. Phase IIa study data indicate that the compound has disease-modifying anti-inflammatory activity in RA patients failing methotrexate therapy. Can-Fite is currently conducting a phase IIb clinical study to demonstrate definitive efficacy, thereby establishing the basis for a phase III development and commercialization partnership. The study will include 230 RA patients at 30 medical sites in Europe and Israel. Participants will derive from the two dose groups that provided the best results in the previous trial, with a control group and a 12-weeks treatment period. The company estimates that trial enrollment will continue for the next 6 months and that study results will be available during the first quarter of 2009.

Under the terms of the agreement, Can-Fite will receive an aggregate consideration of up to $19.5 million USD based on predetermined milestones, until the drug is marketed in Japan. Can-Fite will also receive royalties from the sales of CF101 in the Japanese market. To date, Can-Fite has received $6 million USD from the licensing agreement.