ENMD-2076 has shown promising activity in a completed Phase 1 clinical trial in various types of solid tumors including ovarian, breast, liver, renal and sarcoma, as well as in leukemia, and multiple myeloma, and has also completed a Phase 2 clinical trial in advanced ovarian cancer.
We are currently conducting multiple Phase 2 studies of ENMD-2076 in FLC, triple-negative breast cancer (TNBC), advanced/metastatic soft tissue sarcoma (STS), and advanced ovarian clear cell carcinomas (OCCC).
Our TNBC trial has expanded to include sites in China and is currently enrolling patients. CFDA also approved our clinical trial applications for both a Phase 2 trial of ENMD-2076 for ovarian clear cell carcinoma (OCCC) as well as for advanced/metastatic soft tissue sarcoma (STS).
ENMD-2076 has received orphan drug designation from the U.S. FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia and hepatocellular carcinoma (HCC) and received EU orphan drug designation for the treatment of hepatocellular carcinoma including fibrolamellar carcinomas (FLC)
ENMD-2076 has strong global intellectual property protection worldwide with patents approved or pending for approvals in the U.S., Canada, Japan and many other countries. On May 6, 2013, the Chinese State Intellectual Property Office issued a patent for ENMD-2076 covering composition of matter and uses to treat various cancers.