CASI Files New Drug Clinical Trial Application With China FDA To Expand U.S. Development Of ENMD-2076 In Fibrolamellar Carcinoma

- CASI on track to initiate U.S. Phase 2 trial with ENMD-2076 in FLC by 3Q2015

ROCKVILLE, Md., June 4, 2015 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), 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, announced today that it has filed an application with China's Food and Drug Administration (CFDA) to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076.  The China Phase 2 trial will be an extension of a U.S. Phase 2 trial that is expected to be initiated in the third quarter of this year.

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Ken K. Ren, Ph.D., CASI's Chief Executive Officer, commented, "We are very pleased with the CFDA's acceptance of our application package and look forward to working with them to move the process towards approval.  This is our fourth application to conduct a new drug clinical trial in China for ENMD-2076.  We received approval for our first three applications to conduct trials in ovarian clear cell carcinoma, soft tissue sarcoma, and triple negative breast cancer (TNBC), the latter of which was initiated recently and is currently enrolling patients."  

Dr. Ren further commented, "We continue to protect the proprietary nature of our unique drug candidate ENMD-2076.  In addition to patents already issued in the U.S., China, Japan, Canada, and Australia among others, we have recently secured patent protection in Switzerland, Spain, Germany, France, U.K., Sweden, Korea and other territories.  These recently issued patents add to our robust intellectual property portfolio."   

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 and ovarian clear cell carcinomas and is preparing for a Phase 2 trial in 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. 

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™ (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.  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 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; 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 candidate 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; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest stockholders that differ from our other stockholders; and the risk of substantial dilution of existing stockholders in future stock issuances.  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. 

COMPANY CONTACT:

CASI Pharmaceuticals, Inc.

240.864.2643

ir@casipharmaceuticals.com

INVESTOR CONTACT:

Torrey Hills Capital

Jim Macdonald

858.456.7300

jmacdonald@torreyhillscapital.com

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SOURCE CASI Pharmaceuticals, Inc.

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