Can-Fite BioPharma Ltd (PETACH TIKVA, Israel), a clinical-stage drug development company focused on a portfolio of orally bioavailable, highly selective, small molecule A(3) adenosine receptor (A(3)AR) agonists with potent activities in inflammation and cancer, announced the  completion of patient enrollment in a phase IIb rheumatoid arthritis (RA) clinical trial of CF101, an A(3)AR agonist. About 250 patients have been enrolled in the trial from the US, Europe, and Israel at 36 medical centers worldwide. Study results are expected to be released by the third quarter of 2007.

Can-Fite is developing CF101, its first investigational drug candidate, for three medical indications in the field of inflammatory diseases, including RA (ongoing phase IIb clinical trial), dry eye syndrome (scheduled to initiate phase II trials in Israel), and psoriasis (scheduled to initiate phase II trials in the US). The company has recently developed a blood test to determine A(3)AR levels prior to treatment in order to use it as a biological predictive marker. The A(3)AR was found during a phase IIa study to serve as a biological marker to predict patient response to CF101.
 
Completion of patient enrollment in the phase IIb RA trial triggered a milestone payment of US$500,000 from the Seikagaku Corporation, Can-Fite's development and marketing partner in Japan. Can-Fite entered into an exclusive license agreement with Seikagaku to develop and market CF101 in Japan for the treatment of inflammatory diseases, including RA but excluding eye disorders. In addition, under the terms of this agreement, Can-Fite received US$500,000 in royalties for the future sales of CF101, once approved for use in Japan, in accordance with the provisions that specify an annual payment of royalties every January 1st starting from January 1, 2007, until whichever one of the following occurs first: (i) submission of an investigational new drug (IND) application to the Japanese regulatory authority; or (ii) the beginning of the 6th year from the date of the exclusive license agreement.

Can-Fite was recently granted a patent by the US Patent and Trademark Office (USPTO) on CF101 for the treatment of RA; the patent will expire in 2023. The company's intellectual property portfolio includes composition-of-matter patents and patent applications exclusively licensed for all fields from the National Institutes of Health (NIH) and Leiden University, in The Netherlands, covering its development compounds (CF101, CF102, CF502, and others); and method of use, indication, and mechanism of action claims residing in company-owned intellectual properties. 

—A. Techman

 

The Rheumatologic Perspective