CASI Pharmeceuticals

Press Release

CASI Pharmaceuticals Announces Abstract On ENMD-2076 In Clear Cell Ovarian Cancer

Poster to be Presented at 2017 ASCO Annual Meeting

ROCKVILLE, Md., May 18, 2017- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs today reported the availability of an abstract titled “Phase II Clinical and Molecular Trial of Oral ENMD-2076 in Clear Cell Ovarian Cancer (CCOC)” that was published on May 17, 2017 and is the subject of a poster to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 2-6, 2017 in Chicago, Illinois. The abstract is available at: http://abstracts.asco.org.

Alex Zukiwski, M.D., CASI’s Chief Medical Officer, commented, “The abstract analyzes the data from an investigator-initiated study of ENMD-2076 in pretreated patients with recurrent CCOC conducted by the Princess Margaret Phase 2 Consortium. The trial completed enrollment of 40 patients (37 evaluable) with biomarker analysis still ongoing. The primary endpoints of the study were progression free survival rate (PFS) at 6 months and objective response rate. Exploratory objectives incorporated evaluation of correlative biomarkers on patient outcomes, including the evaluation of ARID1A status which is a known negative prognostic factor in CCOC. The estimated six-month PFS rate was 20% for the evaluable patients, 31% for patients with ARID1A loss, and 12% for patients with ARID1A positive. Median PFS was 3.7 months (m) (95%CI: 3.4-4.4m), in ARID1A loss (19 pts) was 4.1m (95%CI: 3.5-10.3m) vs 3.6m (95%CI: 1.7-3.9m) in ARID1A positive (17 pts) (p=0.024). The loss of ARID1A on archival tissue seems to be associated with better PFS on ENMD-2076. Two patients achieved a partial response (1 unconfirmed) as per RECIST v1.1 criteria.”

Dr. Zukiwski continued, “CCOC is a rare type of ovarian cancer which is difficult to treat and is shown to be relatively non responsive to standard chemotherapy agents. The identification of what appears to be an improved PFS in the patient group with ARID1A loss is encouraging and needs to be further assessed as this potential biomarker could allow for selection of patients who may potentially benefit from ENMD-2076. Evaluation of the clinical data and the correlative biomarker program continues and will help determine the development path in CCOC and potentially for the other tumor types for which ARID1A loss or mutation has been identified.”

About CASI Pharmaceuticals, Inc.
CASI is a U.S. based, late-stage biopharmaceutical company focused on the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a focus on commercialization in China. CASI’s product pipeline features (1) our lead proprietary drug candidate, ENMD-2076, in multiple Phase 2 clinical trials, (2) MARQIBO®, ZEVALIN® and EVOMELA®, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in various stages in the regulatory process for market approval in China, and (3) proprietary early-stage candidates in preclinical 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 CASI’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: 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 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, the difficulty of executing our business strategy in China; our inability to predict when or if our product candidates will be approved for marketing by the China Food and Drug Administration authorities; 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 and early clinical models are not necessarily indicative of later 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.

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