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Transcript
23 October 2006 Press Release Can-Fite progresses through clinical trials: completed enrolment of half the patients required for phase IIb RA trial and is scheduled to receive next payment from the Japanese Seikagaku Corporation Enrolment of half the patients required for Can-Fite's phase IIb clinical trials is one of the milestones set forth in the development and marketing agreement signed with Japanese company Prof. Pnina Fishman, CEO of Can-Fite: “We are very pleased with the current rate of enrolling, more than half the patients required for the trials over this period of time, which shows that we are within the expected timelines is a remarkable achievement. This is a significant progress in the clinical trial program, and we are highly satisfied with it. The cash flow from the Japanese company will be used to continue the development of the company's product line”. Can-Fite, a biotechnology company traded on the Tel Aviv Stock Exchange, is moving ahead with phase IIb clinical trials at a rate higher than expected. Last July, Can-Fite entered phase IIb clinical trials of CF101 in patients with rheumatoid arthritis (RA), after receiving a successful summary report of phase IIa trial results. The trials are being conducted at leading medical centers in the US, Europe and Israel. The company announced today that it enrolled more than half the patients required for its phase IIb RA trial (approx. 250 patients in total). By doing so, Can-Fite has achieved one of the milestones set forth in the development and marketing agreement signed last month with the Japanese Seikagaku Corporation and is scheduled to receive US$ 500,000. Last month Can-Fite announced that it had entered into an exclusive license agreement with the Japanese Seikagaku Corporation to develop and market CF101 in Japan for the treatment of inflammatory diseases, including RA but excluding ophthalmic indications. Under the terms of this agreement, Can-Fite is to receive an aggregate consideration of up to US$ 19.5 million, contingent to achieving agreed milestones, and collect substantial royalties from the sales of CF101 in Japan and from the sales of raw materials needed for the drug manufacturing process. Can-Fite received US$ 3.5 million upfront and has now achieved another milestone, granting it an additional consideration. Prof. Pnina Fishman, CEO of Can-Fite: “Enrolling more than half the patients required for the trials over this period of time is a remarkable achievement. This is a significant progress in the clinical trial program, and we are highly satisfied with it. The cash flow from the Japanese company will be used to continue the development of the company's product line”. Can-Fite develops targeted drugs that specifically attacks affected cells without compromising normal body systems, and therefore have a favourable safety profile. The company's drugs are based on a scientific concept, which was proven in internal 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 pretreatment blood tests to determine the receptor level, which may be a useful tool to predict treatment response. Can-Fite is developing its first drug, CF101, for 3 clinical indications in the field of inflammatory diseases, including: RA (ongoing phase IIb clinical trials in the US, Europe and Israel), dry eye syndrome (phase II trials scheduled to begin in Israel) and psoriasis (phase II trials scheduled to begin in the USA). Entering the preplanned development of CF102 for the treatment of hepatocellular carcinoma (HCC), Can-Fite has now become a company with a diverse line of drugs for the treatment of inflammatory diseases and cancer. About 2 weeks ago, Can-Fite announced that the second drug in the company's development pipeline, CF102, will be developed for the treatment of HCC, among other indications. Can-Fite estimates that phase I clinical trials of CF102 will commence until the end of 2007. 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. For details: Amir Eisenberg, 0528-260285; Shai Eliash 0522-546635; Liron Singer 0525-476661