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Top-line results of Phase IIb study with monotherapy for rheumatoid arthritis

Jan 1st 2014 at 8:45 PM

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced results from a 12-week, placebo-controlled Phase IIb study involving 79 patients with active rheumatoid arthritis ("RA") for its proprietary drug CF101, an A3 adenosine receptor ("A3AR") agonist.

The study entailed 2 arms, a placebo and a CF101 1 mg treated group, in which CF101 was administered orally twice-daily as a monotherapy for 12 weeks to patients with RA. Only patients with elevated baseline expression levels of the biomarker A3AR were enrolled in the study. In the study, CF101 1 mg met all primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of RA as compared to the placebo,

as measured by ACR20 response rates at 12 weeks (ACR20 response rates: placebo = 25%; CF101 = 49%, p=0.035). This advantage was also evident in higher response rates in the CF101 group versus placebo in ACR50 (ACR50 response rates: placebo = 9%; CF101 = 19%) and ACR70 (ACR70 response rates: placebo = 3% ; CF101 = 11%). Similar to the Company's observations in the previously reported CF101 psoriasis trials, the response of patients with RA was cumulative over time, suggesting a consistent anti-inflammatory effect of CF101.

Moreover, half of the RA patients treated with CF101 showed clinically meaningful improvement. CF101 was very well-tolerated with no evidence of immunosuppression. CF101 had an excellent safety profile, as has already been shown in more than 750 patients in previously reported Phase II clinical studies in autoimmune and inflammatory diseases.

Additionally, all treatment-emergent adverse events were mild to moderate in intensity. These results will be presented at the 9th International Congress on Autoimmunity in Nice, France from March 26-30, 2014. "Along with our recently presented interim analysis data with CF101 in psoriasis, results from this study in RA, in which half of the patients treated with CF101 showed clinically meaningful improvement, demonstrate the potential of the A3AR agonist CF101 in inflammatory indications.

The data also supports the notion that A3AR can be used as a biological predictive marker," stated Pnina Fishman, Chief Executive Officer of Can Fite. About CF101 CF101 is a small molecule orally bioavailable drug which binds with high affinity and selectivity to the A3AR, which is known to be over-expressed in inflammatory cells.

The correlation between A3AR expression levels prior to treatment and patients' response to CF101 suggests that the A3AR may be utilized a predictive biomarker to be analyzed prior to patients' treatment. CF101 is currently being developed for the treatment of RA and other inflammatory indications, including psoriasis, for which positive data from an interim analysis of an ongoing Phase II/III study was recently released by the Company.

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