It may take four more years before one of its drug targets come to market, but Israeli biotech drug developer Can-Fite BioPharma is making steady clinical progress on a number of lead compounds that could revolutionize the treatment of a wide range of diseases from arthritis to liver cancer.

The company’s drug discovery program is based on research by Can-Fite’s CEO, Prof. Pnina Fishman, who discovered that the Gi protein associated A3 adenosine receptor (A3AR) is present in inflammatory and cancer cells, but not in healthy ones. Based on this finding, she built a drug discovery platform on two molecules – the CF101 and the CF102.

CF101has shown to be effective against inflammatory diseases such as psoriasis, dry eye syndrome, glaucoma, and rheumatoid arthritis, and is now in Phase II clinical trials – Phase III being the final test stage before the drugs can be approved by the US Food and Drug Administration. Japanese company, Seikagaku, has licensed the CF101 drug discovery platform to treat arthritis for $20 million plus royalties.

Both compounds are in middle to advanced stages of clinical development for a number of indications. Tests for rheumatoid arthritis and glaucoma are about to start Phase IIb studies in Israel, Fishman remarks. Commenting on the news last year that CF101 failed clinical studies in arthritis, she points out that there were three studies. “One of them in arthritis failed when carried out in combination with the drug methotrexate. It was because of the combination,” she tells ISRAEL21c.

Ready for market in four years

Meanwhile Can-Fite’s second compound, CF102, is now being tested in two Phase I/II studies, one against hepatocellular carcinoma, or liver cancer, and in patients with liver damage caused by the hepatitis C virus.

Like pancreatic cancer, the disease which Patrick Swayze succumbed to last year, a diagnosis of liver cancer can be as good as a death sentence, Fishman agrees. The current therapy option, Nexavar, is only marginally effective at slightly extending the life of someone diagnosed with the disease. “This is the only drug, and it prolongs the life of patients for seven to 12 weeks,” Fishman asserts.

Asked whether Can-Fite’s CF102 will improve the prognosis, she responds: “I don’t like to say better or less, because it’s not fair to the company and the patients, but our investigators are happy.”

Both Can-Fite’s CF101 and CF102 are non-toxic in humans and can be taken orally as a pill and both appear to have excellent clinical prospects. Based on clinical results and progress, Fishman estimates that two drugs indications of CF101, for treatment of psoriasis and dry eye, could be ready to market as soon as four years from now.

“Our molecules are related. It’s the same family of compounds that bind to and activate a specific target, present only on the cell surface of pathological cells – on inflammatory cells and cancer and not present on normal body cells. We have a good safety profile because our drug will bind only to diseased cells,” she explains.

New indications for eye disorders are in sight

Based in Kiryat Matalon near Petah Tikva in central Israel, Can-Fite has recently announced that it has filed a patent with the United States National Institutes of Health (the NIH) to treat yet another sight disorder called uveitis, which is a sight-threatening disease. The researchers are aiming for this new indication of CF101 to join their two other ophthalmic applications – for treating glaucoma and dry eye syndrome.

There is no specific treatment for uveitis, currently treated with steroids and systemic immunosuppressive therapy. Afflicting the inner layer of the middle eye, this inflammatory disorder is the root cause of 10 percent of all blindness cases in the US.

Working under a Material-Transfer Cooperative Research and Development Agreement (M-CRADA) with the NIH, Can-Fite has completed animal studies which demonstrate the efficacy of its lead molecule, CF101, for treating autoimmune uveitis.

Can-Fite was founded in 2000 by Fishman, who was then a researcher at the Rabin Medical Center, and patent attorney Dr. Ilan Cohn. The company, which is traded on the Tel Aviv Stock Exchange where it hopes to raise more funds, employs 14 people, 12 in Israel and two in the US through a Boston office. Money raised from venture capital equals about $20 million, not including $30m. raised in public funds.

“We don’t see Can-Fite as a company that markets our compounds,” says Fishman. “We hope to form strategic alliances, with the CF101 and CF102 compounds, and have big companies out-license them, so that we can work together on Phase III trials – as a discovery boutique,” she says, mentioning the support of her partners, Dr. Ken A. Jacobson from the NIH, and Leyden University in the Netherlands, as key to the company’s success.

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