Casi Pharmaceuticals, a biopharmaceutical company based in Rockville, MD, announced that its oncology drug candidate, ENMD-2076, has received Orphan Drug designation (ODD) from the European Medicines Agency (EMA) for the treatment of heptacelluar carcinoma (HCC) including fibrolamellar carcinoma (FLC).  FLC is a rare form of liver cancer that usually occurs in young adults that have no history of liver disease.  It comprises approximately 5% of all HCC.  The total incidence of HCC is estimated to be 780,000 each year worldwide according to World Health Organization.  ENMD-2076 is an orally-active, Aurora  A/angiogenic kinase inhibitor with a unique kinase selectivity profile.  It exerts its effects through multiple mechanisms of action, including anti-proliferative activity and the inhibition of angiogenesis.  Aurora kinases are key regulators of cell regulator, and are often over-expressed in human cancers.  ENMD was also granted ODD by the U.S. FDA in 2014.


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