CASI Pharmaceuticals Announces First Patient Dosed In Phase 2 Trial For ENMD-2076 In Fibrolamellar Carcinoma (FLC)


ROCKVILLE, MD, USA I November 4, 2015 I CASI Pharmaceuticals, Inc. (Nasdaq:CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces the dosing of the first patient in a Phase 2 clinical trial in patients with advanced fibrolamellar carcinoma (FLC) at Memorial Sloan-Kettering Cancer Center. The trial entitled "A Phase 2 Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients with Advanced Fibrolamellar Carcinoma (FLC)" will be evaluating the safety and efficacy of ENMD-2076, an orally-active Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. More information about the trial can be found at

Rong Chen, M.D., CASI's Chief Medical Officer, commented, "Fibrolamellar carcinoma is a rare malignant neoplasm of the liver and is often advanced when diagnosed due to lack of symptoms. It has distinct clinical, histological and prognostic features from conventional hepatocellular carcinoma (HCC).  Because of the current absence of first line treatment options, we feel ENMD-2076 can be a viable candidate to potentially fill a currently unmet medical need and become a first line therapy in the treatment of FLC patients."

Ken Ren, Ph.D., CASI's Chief Executive Officer, commented, "We are excited to further evaluate ENMD-2076 in the treatment of FLC. In our previous Phase 1 trial, we observed therapeutic effects of ENMD-2076 with a FLC patient.  More recently, we also observed its strong anti-tumor activities in a FLC patient derived xenograft (PDX) mouse model, in which tumor volume in the untreated group increased 500% compared to a 60% decrease in tumor volume in the ENMD-2076 treatment group during the 31-day study period.  We believe there is a good correlation between a clearly identified tumor genesis drive gene mutation and the potential sensitivity of the patients to ENMD-2076 therapy, which targets Aurora A, VEGF, and FGFR.  We are optimistic about the drug's potential in the treatment of FLC and look forward to advancing its development."

About ENMD-2076

ENMD-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 1 clinical trials in solid tumors including ovarian, breast, liver, renal and sarcoma, as well as in leukemia and multiple myeloma. ENMD-2076 is currently in Phase 2 clinical trials in multiple indications, including triple-negative breast cancer, soft tissue sarcoma, ovarian clear cell carcinomas and fibrolamellar carcinoma. ENMD-2076 has received orphan drug designation from the U.S. FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia, and hepatocellular carcinoma.  ENMD-2076 has received orphan drug designation from the European Medicines Agency Committee for Orphan Medicinal Products for the treatment of hepatocellular carcinoma, including fibrolamellar carcinoma.

About CASI Pharmaceuticals, Inc.

CASI is 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. CASI's product pipeline includes exclusive rights to ZEVALIN® (ibritumomab tiuxetan), MARQIBO® (vinCRIStine sulfate LIPOSOME injection) and EVOMELA™ (CE-Melphalan HCI for injection) for greater China (including Taiwan, Hong Kong andMacau). CASI's development pipeline also includes its proprietary drug candidate ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial) currently under reformulation 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 and in the Company's filings with the U.S. Securities and Exchange Commission.

SOURCE: CASI Pharmaceuticals

Published on Thursday, 05 November 2015

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