CASI Pharmaceuticals Announces First Patient Dosed In Phase 2 Trial For ENMD-2076 In Fibrolamellar Carcinoma (FLC)
ROCKVILLE, Md., Nov. 4, 2015 - CASI Pharmaceuticals, Inc. (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 www.clinicaltrials.gov.
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.”
