Can-Fite has obtained Food and Drug Administration (FDA) approval to conduct a phase I study with its liver cancer treatment drug, CF102. Can-Fite also received a $0.5 million minimal royalty payment on CF101, autoimmune diseases drug candidate, from its Japanese partner Seikagaku Corporation (SKK).

The payment is part of the royalties SKK had agreed to pay under the licensing agreement for the development and marketing in Japan of CF101 for the treatment of rheumatoid arthritis, dry eye syndrome and psoriasis.

CF102, which was developed based on Can-Fite's platform technology, is a targeted drug that binds with high affinity to the A3 adenosine receptor. This receptor is highly expressed on the surface of cancer cells but not on normal cells. CF102 binds to its target on cancer cells and triggers programmed cell death (apoptosis).

Can-Fite currently intends to develop CF102 for the treatment of liver cancer and other liver pathologies. Liver cancer is highly common in patients infected with the hepatitis virus and in patients with alcohol addiction. This virus is highly prevalent in Eastern Asia, where liver cancer is the leading cause of cancer related death. According to the information available to Can-Fite, about 630,000 people worldwide are diagnosed with liver cancer each year.

CF102 has shown efficacy in laboratory and preclinical studies of liver cancer. Preclinical development has established that the safety profile of this drug is optimal, thus enabling to advance it into human studies. A phase I study in healthy volunteers will be conducted in the US by a clinical research organization (CRO) in a phase I unit. Can-Fite estimates that this study will be initiated on Q1 2008, and results should be published by the end of Q1 2008.

Prof. Pnina Fishman, CEO, Can-Fite, said, "the initiation of this study is a substantial progress for the Company, since it reflects the expansion of our development pipeline with a drug for additional indication. There are almost no competing therapies for liver cancer and there is a market need because the response rate of these patients to curative chemotherapy is very low. Our drug works through a unique mechanism that allows liver cancer cells to be targeted and attacked with high specificity."

Can-Fite has also entered the development of CF102 for the treatment of liver cancer, including liver cancer, hepatitis virus infections and liver tissue regeneration, the company said.

Can-Fite Biopharma Ltd focuses on the development of molecule-based drugs that bind to receptors of cancerous or inflammatory cells and inhibit their development.