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news.Can-Fite BioPharma has received orphan drug status from FDA for its drug candidate, CF102, for the treatment of hepatocellular carcinoma (primary liver cancer).
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CF102 is a small orally bioavailable drug which bind with high affinity and selectivity to the A3 adenosine receptor.
The latter is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the safety profile of the drug.
The drug induces a anti-tumor effect via de-regulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.
Can-Fite CEO Pnina Fishman said this designation is an additional important milestone in the development of CF102, and follows the successful Phase I/II results.