These findings were obtained through analysis of the results of a phase IIa clinical trial in patients with RA. A trial conducted by the company revealed that patients with high expression of A(3)AR achieved a significant response to CF101, whereas patients with low expression exhibited only a minor response. High expression of target cells was found in 70% of the patients. Internal trials suggest that the drug target is only expressed on the surface of diseased cells. Using pre-treatment blood tests to determine A(3)AR levels may be a useful tool to predict treatment response in a variety of inflammatory diseases. Can-Fite has recently announced that the same target is also over-expressed in patients with psoriasis; the company is now in preparation to initiate a phase II clinical trial in this patient population.
Can-Fite is developing its first drug, CF101, for three medical indications in the field of inflammatory diseases, including: RA (ongoing phase IIb clinical trials in the US, Europe, and Israel), dry eye syndrome (scheduled to initiate phase II trials in Israel), and psoriasis (scheduled to initiate phase II trials in the US).
Recently, Can-Fite announced that it had entered into an exclusive license agreement with the Japanese Seikagaku Corporation to develop and market CF101 in Japan for the treatment of inflammatory diseases, including RA but excluding eye disorders. Under the terms of this agreement, Can-Fite is to receive an aggregate consideration of up to US$19.5 million (including US$3.5 million upfront payment), contingent on achieving agreed to milestones, and collect substantial royalties from the sale of CF101 in Japan and from the sale of raw materials needed for manufacturing the drug. Can-Fite has enrolled more than half the patients required for its phase IIb RA trial (approximately 250 patients in total), thereby achieving one of the milestones set forth in the development and marketing agreement with Seikagaku and is scheduled to receive US$500,000.
—A. Techman
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