Orphan Drug Designation Granted for New Agent in Hepatocellular Carcinoma


Get Permission

CASI Pharmaceuticals, Inc, announced that its investigational agent ENMD-2076 has received orphan drug designation from the U.S. Food & Drug Administration (FDA) for the treatment of hepatocellular carcinoma. ENMD-2076 is an orally active Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action.

The drug has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase, which is a key regulator of mitosis and is often overexpressed in human cancers. ENMD-2076 also targets the ­VEGFR, Flt-3, and FGFR3 kinases, which have been shown to play important roles in the pathology of several cancers.

ENMD-2076 previously received orphan drug designation from the FDA for the treatment of ovarian cancer, multiple myeloma, and acute myeloid leukemia. Phase II studies of ENMD-2076 in ovarian cancer, triple-negative breast cancer, metastatic soft-tissue sarcoma, and advanced ovarian clear cell carcinomas are currently underway. ■

 


Advertisement

Advertisement



;
Advertisement

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.