CASI Pharma Granted Type C Meeting With FDA For ENMD-2076 In FLC - Quick Facts

(RTTNews) - CASI Pharmaceuticals, Inc. (CASI), a clinical-stage pharmaceutical company, reported that it has been granted a Type C meeting with the U.S. Food and Drug Administration or FDA and that the meeting will be held in February 2015.

The company said during this meeting, it will seek guidance on the clinical trial protocol design and the regulatory path forward to obtain marketing approval for ENMD-2076 for the treatment of fibrolamellar carcinoma or FLC.

Ken K. Ren, Ph.D., CASI's Chief Executive Officer, stated, "We look forward to advancing our investigational drug ENMD-2076 for fibrolamellar carcinoma, a rare malignant neoplasm of the liver that represents a subset of hepatocellular carcinoma, and often times affects adolescents and young adults with no history of primary liver disease.  There is currently no standard first-line systemic treatment option available for FLC, which has a distinct clinical and histological prognosis.  We believe that our proprietary drug candidate ENMD-2076, which targets Aurora A, VEGF and FGFR, has potential to treat FLC."