Casi Pharmaceuticals (CASI)

[Rocky I]

Data On Anti-Tumor Activity Of ENMD-2076 In Triple Negative Breast Cancer Animal Models Presented In Poster Session At AACR-NCI-EORTC International Conference

ROCKVILLE, Md. (November 8, 2015) – CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces a poster presentation by investigators of the University of Colorado, on a study of ENMD-2076 in p53 mutated triple negative breast cancer (TNBC) models at the AACR-NCI-EORTC International Conference, November 5-9 in Boston, Massachusetts. To view the poster, visit the Company’s website at http://www.casipharmaceuticals.com.

Rong Chen, M.D., CASI’s Chief Medical Officer, commented, “The purpose of this study is to further characterize the activity of ENMD-2076 on p53 mutant TNBC patient derived tumor xenograft (PDTX) models as related to its sensitivity and resistance. Data presented reveals significant anti-tumor activities of ENMD-2076 in a subset of p53 mutated TNBC PDTX models. The sensitivity is attributed to the induction of p73 which may mediate the response in the absence of functional p53, while the resistance is associated with a loss of p73 expression.”

Dr. Chen further commented, “The data is in line with our belief that ENMD-2076 may provide clinical benefit to a subset of TNBC patients. Understanding the role of mutant p53 in mediating response to ENMD-2076 in TNBC may lead to a p53-based patient selection strategy and contribute to the advancement of ENMD-2076 as a personalized target therapy.”

“Our TNBC Phase 2 trial in the U.S. has completed patient recruitment and study treatment,” continued Dr. Chen. “Efficacy activities were observed in a subset of patients while correlative biomarker analysis with clinical benefit is currently underway at the University of Colorado. As part of our Phase 2 trial and under the same protocol, we have begun patient recruitment and treatment at our multi-center sites in China, where we are studying efficacy and safety as well as correlative biomarkers of ENMD-2076 in an expanded patient population.”

Ken Ren, Ph.D., CASI’s Chief Executive Officer, commented, “Our goal is to reach a clinical inflection point with the identification of clinically correlative biomarker(s) prior to the end of next year in order to support a Phase 3 trial in a well-defined subset of a TNBC patient population. We believe there is strong potential for the development of ENMD-2076 as a personalized target therapy for TNBC.”