Casi Pharmaceuticals (CASI)

[Rocky I]

Poster For ENMD-2076 Phase 2 Trial In Soft Tissue Sarcoma Presented At The 2015 Connective Tissue Oncology Society Annual Meeting

ROCKVILLE, Md., Nov. 5, 2015 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces a poster presentation on a Phase 2 study of ENMD-2076 in soft tissue sarcoma (STS) at the 2015 Connective Tissue Oncology Society (CTOS) annual meeting in Salt Lake City, Utah, November 4-7, 2015. 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 Phase 2 study was designed to evaluate clinical activity and safety of ENMD-2076 as a monotherapy in the treatment of metastatic STS in correlation with genetic biomarker(s). The data, presented by the investigators of Princess Margaret Cancer Centre at Toronto University, revealed clinical benefit, either partial response (PR) or stable disease (SD) for more than 6 months, in 17% of patients studied. Genetic variations in CCL11 and FLNB were shown to be potentially associated with the clinical benefit from ENMD-2076, while gene variations in EGFR and CYP4B1 polymorphism could be associated with lack of clinical benefit.”

Dr. Chen further commented, “The findings confirm our rationale that ENMD-2076 may provide clinical benefit to a subset of STS patients, which may lead to the development of personalized target therapy. The identification of potential clinical correlative biomarkers provides valuable information for our continued development of ENMD-2076 in STS. We are on track to initiate our Phase 2 trial for STS in China, which will be conducted under the same protocol and will allow us to investigate and further validate the drug’s clinical activities and correlative biomarkers 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 correlative biomarker(s) prior to the end of next year so as to support Phase 3 trials in a well-defined subset of STS patients.”

Dr. Ren continued, “We also remain on track with our other clinical trials for ENMD-2076 in triple negative breast cancer (TNBC) and ovarian clear cell carcinoma (OCCC). Enrollment in our China sites for TNBC is currently underway. We remain optimistic about having ENMD-2076 developed as a personized target therapy for STS, TNBC and/or OCCC, as cumulative evidence has shown clinical benefit of the drug in a subset of patients in each of the indications.”