CF101 drug fails to meet primary efficacy endpoint in phase III study for Dry Eye Syndrome

Can-Fite BioPharma Ltd. (TASE:CFBI), (NYSE MKT:CANF), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that its subsidiary OphthaliX Inc. (OTCBB:OPLI) released results from a 24 week, placebo-controlled phase III study involving 237 patients with moderate-to-severe Dry Eye Syndrome who were treated with its licensed drug CF101, an A3 adenosine receptor agonist. The patients were randomized to receive two oral doses of CF101 (0.1 mg or 1.0 mg) or a placebo, for a period of 24 weeks.

In the study, CF101 did not meet the primary efficacy endpoint of complete clearing of corneal staining, nor the secondary efficacy endpoints. Nonetheless, CF101 was found to be well tolerated.

CF101 is developed by Can-Fite for anti-inflammatory indications. Last week, Can-Fite announced positive data from a Phase II clinical trial in Rheumatoid Arthritis. In addition, Can-Fite is conducting a phase II/III clinical study in patients with Psoriasis. Can-Fite announced positive interim analysis of the Psoriasis study several months ago and patients enrollment in the second segment is ongoing in the United States, Europe and Israel. The final data from this study is expected to be released during 2014.

Global Data estimates that the global market for rheumatoid arthritis therapeutics was $12 billion in 2010 and is projected to reach $18 billion by 2020. The global market for treating psoriasis was $3.3 billion in 2010 and is projected to reach $6.7 billion by 2018, according to Global Data.

OphthaliX is also developing CF101 for the treatment of Glaucoma and Uveitis. The interim data from the ongoing phase II study in Glaucoma is expected to be released during 2014.

Can-Fite already has licensing agreements in place for up to approximately $22 million in upfront and milestone payments, plus royalties upon commercialization for CF101 for anti-inflammatory indications with Seikagaku Corporation in Japan and with Kwang Dong Pharmaceutical Co. Ltd in South Korea. Can-Fite has already received approximately $8 million in upfront and milestone payments to date.

"We are disappointed from the fact that the phase 3 clinical trial for the treatment of Dry Eye Syndrome did not meet the endpoints. We intend to learn the trial results and extract from the clinical data received the lessons required for the successful advancement of Can-Fite's compounds in various indications. The fact that the safety profile of CF101 remains high and is consistent is very encouraging and emphasizes an important advantage of CF101 compared to other drugs on the market. Our recently released positive data from our RA phase IIb clinical study and the positive interim analysis of data with respect to CF101 for the treatment of psoriasis, in which half of the patients treated with CF101 showed clinically meaningful improvement, both demonstrate the potential of the A3AR agonist CF101 for autoimmune inflammatory indications. We believe in the platform technology and will continue to develop it for the appropriate indications," stated Pnina Fishman, Chief Executive Officer of Can-Fite.

SOURCE Can-Fite BioPharma Ltd.