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Can-Fite to Initiate Clinical Studies to Test Efficacy of CF101 in Treating Dry Eyes Syndrome

Posted on: Monday, 3 April 2006, 12:00 CDT

Can-Fite BioPharma (TASE:CFBI), a world leader in development of drugs that are agonists of the A3 adenosine receptor (A3AR agonists), announced today that it began its preparation to initiate a pilot clinical study to test efficacy of its lead drug, CF101, in ameliorating dry eye symptoms.

The Company intends to conduct this clinical study in Israel and it will begin within a few months. The company expects to have definitive data from this clinical study in the second quarter of 2007. In the study the effect of oral CF101 on increase in tear production will be tested.

Dry eye syndrome, also known as Keratitis Sicca, is a chronic eye disease that results from inadequate tear volume, leading to eye irritation that may lead to temporary or at times permanent impairment in vision. It is a disease that is commonly found in rheumatoid arthritis (RA) patients. As was recently announced by Can-Fite (press release of January 30), dry eye symptoms of several RA patients that participated in Can-Fite's Phase IIa study and that also suffered from Keratitis Sicca were significantly improved following treatment with CF101. Dry eye syndrome is a condition affecting more than 6 million people in the US alone. Other than symptomatic treatment and the use of general immunosuppressive drugs, there are currently no drug therapies for the treatment of this disease. A therapy for treating dry eyes targets a huge therapeutic market.

"The findings that were obtained from our clinical studies in rheumatoid arthritis patients, although preliminary, are a very encouraging indication on the efficacy of CF101 in treating dry eye syndrome," said Dr. Pnina Fishman, the company's CEO. "The market for this drug is huge and there are no good drugs available for treating this disease. Should the efficacy of this drug be confirmed in our coming trial, a new development avenue and on business opportunities may open for CF101," added Dr. Fishman.

As already previously announced by the Company (see press release of March 6, 2006), it has submitted patent applications on the use of A3 adenosine receptor agonists in treating dry eyes that it believes will secure its dominant position in this therapeutic field.

About Can-Fite

Can-Fite BioPharma Ltd. is a public company, traded on the Tel-Aviv Stock Exchange that is headquartered in Petach-Tikva, Israel. The company, which began its operations at the end of 2000 was founded based on the work by Professor Pnina Fishman, formerly a Tumor Immunologist in the Rabin Medical Center and currently the company's CEO, together with Dr Ilan Cohn, Patent Attorney and Senior Partner at Reinhold Cohn and Partners, a leading Israeli Patent Attorney firm. The Company has research laboratories and offices in Israel. The Company's lead drug, CF101, for the treatment of rheumatoid arthritis is currently in Phase II clinical trials and to date went through clinical trials in the USA, UK and Israel.

About CF101

CF101 is a small molecule, which is administered to patients orally. This drug, which is developed for the treatment of rheumatoid arthritis, was tested to date in clinical trials in the USA, UK and Israel. The drug is active against a wide variety of autoimmune and cancer diseases and has a preferential safety profile. The drug's main advantage is in its ability to specifically attack pathological cells without affecting healthy ones. In addition, the fact that the drug is administered orally in the form of a capsule creates a huge advantage vs. current treatments which are administered by IV infusion or injection, at much higher costs.

Rheumatoid arthritis (RA) is a severe and chronic autoimmune disease that affects more than 1% of the population in the Western World. The disease is characterized mainly by inflammation of the lining, or synovium, of the joints that can lead to long-term joint damage, resulting in chronic pain, loss of function and disability. The market of disease modifying anti-rheumatic drugs is estimated to be about US $5 billion and is expected to rise to about $7 billion by 2007.

NOTE TO EDITORS: The 3s in A3AR and A3 should be subscript. They were changed for transmission purposes only.

Source: Business Wire

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