CASI Pharmaceuticals Announces Abstract On ENMD-2076 In Clear Cell Ovarian Cancer

ROCKVILLE, Md., May 18, 2017

Alex Zukiwski, M.D., CASI's Chief Medical Officer, commented, "The abstract analyzes the data from an investigator-initiated study of ENMD-2076 in pretreated patients with recurrent CCOC conducted by the Princess Margaret Phase 2 Consortium. The trial completed enrollment of 40 patients (37 evaluable) with biomarker analysis still ongoing. The primary endpoints of the study were progression free survival rate (PFS) at 6 months and objective response rate. Exploratory objectives incorporated evaluation of correlative biomarkers on patient outcomes, including the evaluation of ARID1A status which is a known negative prognostic factor in CCOC. The estimated six-month PFS rate was 20% for the evaluable patients, 31% for patients with ARID1A loss, and 12% for patients with ARID1A positive. Median PFS was 3.7 months (m) (95%CI: 3.4-4.4m), in ARID1A loss (19 pts) was 4.1m (95%CI: 3.5-10.3m) vs 3.6m (95%CI: 1.7-3.9m) in ARID1A positive (17 pts) (p=0.024). The loss of ARID1A on archival tissue seems to be associated with better PFS on ENMD-2076. Two patients achieved a partial response (1 unconfirmed) as per RECIST v1.1 criteria."

Dr. Zukiwski continued, "CCOC is a rare type of ovarian cancer which is difficult to treat and is shown to be relatively non responsive to standard chemotherapy agents. The identification of what appears to be an improved PFS in the patient group with ARID1A loss is encouraging and needs to be further assessed as this potential biomarker could allow for selection of patients who may potentially benefit from ENMD-2076. Evaluation of the clinical data and the correlative biomarker program continues and will help determine the development path in CCOC and potentially for the other tumor types for which ARID1A loss or mutation has been identified."

About CASI Pharmaceuticals, Inc.
CASI is a U.S. based, late-stage biopharmaceutical company focused on the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a focus on commercialization in China. CASI's product pipeline features (1) our lead proprietary drug candidate, ENMD-2076, in multiple Phase 2 clinical trials, (2) MARQIBO^®, ZEVALIN^® and EVOMELA^®, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in various stages in the regulatory process for market approval in China, and (3) proprietary early-stage candidates in preclinical development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com and in CASI's filings with the U.S. Securities and Exchange Commission.

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