News Releases

ROCKVILLE, Md., Nov. 8, 2015 /PRNewswire/ -- 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."

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 and Macau). 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 www.casipharmaceuticals.com and in the Company's filings with the U.S. Securities and Exchange Commission.

Forward Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals, including, without limitation, with respect to the closing of the private placement offering and the anticipated use of the net proceeds.  Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed.  Actual results could differ materially from those currently anticipated due to a number of factors, including: the risk that the closing of the private placement offering does not occur, that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility in the market price of our common stock; risks relating to interests of our largest stockholders that differ from our other stockholders; the risk of substantial dilution of existing stockholders in future stock issuances, including as a result of the closing of the private placement offering; the difficulty of executing our business strategy in China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with any early-stage products under development; the risk that results in preclinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; dependence on third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).  Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition.  We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

ZEVALIN^® and MARQIBO^® and EVOMELA™ are proprietary to Spectrum Pharmaceuticals, Inc. and its affiliates. 

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SOURCE CASI Pharmaceuticals, Inc.