CASI receives CFDA approval for ENMD-2076 Phase 2 clinical trial in ovarian clear cell carcinoma

CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that the China Food and Drug Administration (CFDA) has approved the Company's application to conduct a Phase 2 global clinical trial in ovarian clear cell carcinoma (OCCC) patients for its proprietary drug candidate ENMD-2076.

The approval will allow CASI to expand its ongoing Phase 2 OCCC trial currently underway in multiple centers in North America with Princess Margaret Cancer Centre in Toronto, Canada as the lead institution. This will be the Company's third approval of a global Phase 2 clinical trial in China, the first being for advanced triple-negative breast cancer in which the first patient was enrolled last week at the Cancer Hospital of Chinese Academy of Medical Science in Beijing and the second being for advanced soft tissue sarcoma. More information about the three trials can be found at www.clinicaltrials.gov.

Ken K. Ren, Ph.D., CASI's Chief Executive Officer, commented, "Our excitement about this trial is two-fold. First, CFDA's approval of this third application supports our commitment to our global development strategy for ENMD-2076 to include China as an important component under our US/China development model. Second, we will be able to explore the therapeutic potential of ENMD-2076 in the Chinese OCCC patient population which may show a distinct sensitivity profile."

Rong Chen, M.D., Ph.D., CASI's Chief Medical Officer, stated, "The Phase 2 trial in North America is progressing as planned under the direction of Dr. Amit M. Oza, who is the principal investigator of the trial at Princess Margaret Cancer Centre. We are very pleased that we can now expand the trial into China with the recruitment of more patients. Data from this China trial will be evaluated in conjunction with data being collected in the Canadian/US trials in an effort to further advance the development of ENMD-2076."