Can-Fite Commences Phase II Clinical Trial for Additional Indication of Dry Eye Syndrome.

The Company is concurrently conducting a clinical trial for the indication of rheumatoid arthritis

Prof. Pnina Fishman CEO of Can-Fite, said today that "commencing this trial is a highly significant event in the life of our Company. It is the first in a series of eye disorder trials, an area into which Can-Fite has recently entered. The Company's products are currently indicated for three different therapeutic areas, including autoimmune inflammatory diseases, cancer and eye disorders."

PETACH TIKVA, Israel -- Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, is progressing through clinical trials for an additional indication of Dry Eye Syndrome. The company announced today that it has commenced patient enrolment in a phase II clinical trial of CF101 for the amelioration of dry eye symptoms. This clinical trial will be conducted in Israel and include 50 patients, who will be treated for 12 weeks at the following 4 medical centers: Assaf Harofeh, Rabin, Sheba and Meir.

The trial results will also be presented to the FDA (US Food and Drug Authority) and if the drug is shown to be effective, Can-Fite may apply to obtain an orphan drug status, which if granted would lead to a substantial increase in the rate of drug development.

Pnina Fishma, CEO of Can-Fite, said today that "commencing this trial is a highly significant event in the life of our Company. It is the first in a series of eye disorder trials, an area into which Can-Fite has recently entered. The Company's products are currently indicated for three different therapeutic areas, including autoimmune inflammatory diseases, cancer and eye disorders."

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. Based on published data, Dry Eye Syndrome affects more than 6 million people in the US alone, and the market for treatments is estimated at about US$ 1 billion. 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. Can-Fite entered the development of the drug for this indication after learning that, during a phase IIa rheumatoid arthritis trial, several patients reported a significant improvement in their dry eye symptoms following treatment with CF101.

Dry Eye Syndrome is generally associated with an inflammatory process in the lachrymal gland. Because CF101 has an anti-inflammatory effect, it seems that its mechanism of activity, which has been widely studied by Can-Fite scientists, supports the use of CF101 for the amelioration of Dry Eye Syndrome. The current standard of care is eye drops administered many times a day. These eye drops do not cure the cause or alter the course of the disease, but are only used for lubrication and alleviation of symptoms.

This phase II trial in patients with Dry Eye Syndrome is added to an ongoing clinical trial conducted by Can-Fite in patients with rheumatoid arthritis. About 2 weeks ago, Can-Fite announced that it had completed the enrolment of 250 patients in a phase IIb rheumatoid arthritis trial. Completion of enrolment was a milestone in the marketing agreement recently signed with the Japanese Seikagaku Corporation, and Can-Fite received US$ 500,000 for achieving it. Can-Fite also received a further royalty payment of US$ 500,000.

Can-Fite develops targeted drugs that specifically attacks affected cells without compromising normal body systems, and therefore have a favorable safety profile. The Company's drugs are based on a scientific concept, which was proven in trials, suggesting that the target of the drug is only expressed on the surface of affected cells. The Company has recently developed a procedure that uses pre-treatment blood tests to determine the receptor level, which may be indicative of treatment response.

Can-Fite is developing its first drug, CF101, for 4 clinical indications in the field of inflammatory diseases, including: rheumatoid arthritis (ongoing phase IIb clinical trials in the US), Dry Eye Syndrome (ongoing phase II trials in Israel), psoriasis (initial development phase) and uveitis. The Company has also begun the development of CF102 for the treatment of liver cancer.

CAN-FITE BIOPHARMA LTD is a public company traded on the Tel Aviv Stock Exchange. The Company, which commenced business activity in 2000, was founded by researcher Prof. Pnina Fishman and patent attorney Dr. Ilan Cohn. The Company focuses on the development of molecule-based drugs that inhibit the development of cancer or inflammatory cells. The market for the company's drugs is estimated at billions of dollars.