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CASI Pharmaceuticals Reports Second Quarter 2014 Financial Results
Date:8/14/2014

res as we advance the development of ENMD-2076." 

Commenting on the Company's most recent milestones, Dr. Ren added, "Subsequent to the close of the second quarter the Company was granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for ENMD-2076 in hepatocellular carcinoma and was also granted approval from China's Food and Drug Administration (CFDA) to start a Phase II trial of ENMD-2076 in Chinese patients with triple-negative breast cancer (TNBC).  CFDA's approval will allow CASI to fully embrace our U.S./China business strategy and we look forward to starting a TNBC trial in China.  The data from these patients will also be used in support of our U.S. regulatory strategy." 

About ENMD-2076ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action.  ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase.  Aurora kinases are key regulators of mitosis (cell division), and are often over-expressed in human cancers.  ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases, which have been shown to play important roles in the pathology of several cancers.  ENMD-2076 has shown promising activity in Phase I clinical trials in solid tumor cancers including ovarian, breast, liver, renal and sarcoma, as well as in leukemia and multiple myeloma.  CASI is completing a Phase II trial of ENMD-2076 in ovarian cancer.  In addition, CASI is conducting a dual-institutional Phase II study of ENMD-2076 in triple-negative breast cancer, a Phase II study in advanced/metastatic soft tissue sarcoma and a Phase II ovarian clear cell carcinomas. ENMD-2076 has received orphan drug designation from the U.S. FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia, and
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SOURCE CASI Pharmaceuticals, Inc.
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