CASI Pharmaceuticals announced that the FDA has granted Orphan Drug designation to ENMD-2076 for the treatment of hepatocellular carcinoma (HCC).
ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase. ENMD-2076 also targets VEGFR, Flt-3, and FGFR 3 kinases.
ENMD-2076 has shown activity in Phase 1 clinical trials in solid tumor cancers including ovarian, breast, liver, renal, and sarcoma, as well as in leukemia and multiple myeloma. CASI is completing a Phase 2 trial of ENMD-2076 in ovarian cancer as well as a dual-institutional Phase 2 study of ENMD-2076 in triple-negative breast cancer, a Phase 2 study in advanced/metastatic soft tissue sarcoma, and a Phase 2 study in advanced ovarian clear cell carcinomas.
ENMD-2076 has also received Orphan Drug designation for the treatment of ovarian cancer, multiple myeloma and acute myeloid leukemia.
For more information call (240) 864-2600 or visit Casipharmaceuticals.com.
This article originally appeared on MPR