US-based, biopharmaceutical company CASI Pharmaceuticals has received approval from China's Food and Drug Administration (CFDA) to conduct a Phase ll clinical trial of ENMD-2076 in patients with fibrolamellar carcinoma (FLC).
ENMD-2076 is an orally-active, Aurora A / angiogenic kinase inhibitor with a 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 are key regulators of mitosis (cell division), and are often over-expressed in human cancers.
CASI Pharmaceuticals CEO Dr Ken Ren said: "We are pleased with CFDA's approval of our application to expand the ongoing Phase ll trial for FLC into China.
"This is our fourth approval from CFDA to conduct Phase ll trials with our novel and orally-active Aurora A / angiogenic kinase inhibitor, and confirms our core competency to navigate and obtain CFDA approvals to conduct trials in China as part of a global clinical programme."
Dr Ren also noted the company's current Phase ll trial of ENMD-2076 in FLC is being conducted at five sites in the US, including Memorial Sloan Kettering Cancer Centre, Dana Farber Cancer Centre, University of California in San Francisco, University of Colorado-Denver, and University of Texas Southwestern Medical Centre.
CASI stated that it is completing a Phase ll trial of ENMD-2076 in ovarian cancer.
Additionally, CASI is conducting a dual-institutional Phase ll study of ENMD-2076 in triple-negative breast cancer, a Phase ll study in advanced / metastatic soft tissue sarcoma, a Phase ll ovarian clear cell carcinomas and a Phase ll study in FLC.
ENMD-2076 has received orphan drug designation from the US FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukaemia, hepatocellular carcinoma and EU orphan drug designation for the use of ENMD-2076 to treat hepatocellular carcinoma (HCC), including FLC.