Casi Pharmaceuticals (CASI)

[Rocky I]

From CFDA To Conduct Phase 2 Clinical Trial With ENMD-2076 For Fibrolamellar Carcinoma (FLC)

ROCKVILLE, Md., May 12, 2016 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces that China’s Food and Drug Administration (CFDA) has approved the Company’s application to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076.

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, commented, “We are pleased with CFDA’s approval of our application to expand the ongoing Phase 2 trial for FLC into China. This is our fourth approval from CFDA to conduct Phase 2 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 program.”

Dr. Ren commented further, “Our current Phase 2 trial of ENMD-2076 in FLC is active at five sites – Memorial Sloan Kettering Cancer Center, Dana Farber Cancer Center, University of California at San Francisco, University of Colorado-Denver, and University of Texas Southwestern Medical Center. The recruitment is going very well. We are optimistic about ENMD-2076’s potential in the treatment of FLC and look forward to advancing its development.”