Download completed enrolment of half the patients required for phase IIb RA

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