Drug to treat dry eyes promising, says Can-Fite

A new drug to treat dry eye is showing promising results in human studies.

The new drug named CF101 is being developed by Can-Fite BioPharma, a biotechnology company based in Israel.

CF101 results studied in 80 patients showed the drug is effective in treating dry eye disease or keratoconjunctivitis sicca. Phase II clinical study using CF101 to treat patients with moderate to severe Dry Eye Syndrome had successfully met the primary efficacy endpoint, the company said in a press statement.

Patients in this masked study were randomly assigned to either 1 mg of CF101 or matching placebo, a dummy pill. CF101 was taken orally as a monotherapy – as a single drug – for 12 weeks. The 12 week duration is one that Can-Fite has used in other trials of CF101 as an anti-inflammatory agent, and is similarly a common one for Phase II trials of Keratoconjunctivitis Sicca.

The patient group receiving CF101 demonstrated statistically significant improvement in superficial punctate keratitis, relative to the placebo group, as measured by fluorescein staining. This sensitive and prevalent measure of corneal disease was prospectively defined as a primary study endpoint, thus demonstrating the ability of orally administered CF101 to exert beneficial effects on ocular surface inflammation. An improvement in additional study parameters was also observed. CF101 was safe and well tolerated during the study period.

Prof. Isaac Avni, Director of Ophthalmology, Assaf-Harofea Medical Center and the study principal investigator, said today “there is a linear increase in the number of patients suffering from dry eye syndrome all over the world and we are very happy with the positive results of this Phase II study. In addition to the impressive data demonstrating an improvement in the signs and symptoms of Dry Eye Syndrome, I am very excited by the data showing that CF101 decreased the intraocular pressure in the patients participated in this study.”

These findings supply evidence for the efficacy of CF101 alone as a systemic anti-inflammatory drug, CanFite release said.

Recently, Can-Fite announced that a Phase IIb study with CF101, in combination with methotrexate, failed to meet its primary end point in the treatment of rheumatoid arthritis, most probably due to lack of efficacy in the combined treatment.

CanFite is currently studying the efficacy of CF101 in patients with psoriasis, as well. The Phase II study  is ongoing  and based on Can-Fite’s estimations, data will be released during Q3 2009.

Adenosine A3 receptors are G protein-coupled receptors that are involved in a variety of intracellular signaling pathways and physiological functions.

Dry Eye Syndrome affects a large proportion of the general population, including contact lens users and postmenopausal women, and is also associated with rheumatoid arthritis. Dry eye syndrome affects more than 30 million people in the US alone, and the market for treatments is estimated at about US$ 1 billion, according to estimates. In addition, it was also suggested by the scientific community that developing effective ethical drugs for the treatment of dry eye syndrome may increase the market size.

CF101 has also been found effective in decreasing the intraocular pressure in patients. This finding may pave the way towards additional clinical applications of adenosine A3 agonists in the ophthalmology arena such as glaucoma.

Can-Fite Biopharma Ltd focuses on the development of small molecule-based drugs that bind to receptors of cancerous or inflammatory cells and inhibit their development. Can-Fite’s development pipeline currently has two drugs: CF101 and CF102. The company is simultaneously conducting several pre-clinical and clinical trials with the two drugs for various indications. CF101 is being studied for the treatment of  psoriasis (Phase II). Can-Fite develops CF102 for the treatment of liver conditions, including liver cancer and hepatitis infections.