Saturday, April 15, 2017
CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported today that along with the investigators a decision has been reached to stop further patient enrollment in its Phase 2, open-label study of ENMD-2076 in previously treated locally advanced or metastatic triple-negative breast cancer (TNBC) conducted at the University of Colorado, Denver and the Indiana University Melvin and Bren Simon Cancer Center. The study was a 2 stage design which targeted an accrual of 35 patients. The patient number was expanded to take into consideration those patients which may not be evaluable for efficacy analysis as per the protocol. In this uncommon tumor type and challenging setting to recruit, a total of 41 patients have been enrolled which has been determined to be sufficient to assess the potential efficacy of ENMD-2076 in this patient population and for our ongoing biomarker analysis. The Company continues to collect and evaluate data in those patients enrolled in the study, and the biomarker program which evaluates potential markers that could be predictive of a response to ENMD-2076 is ongoing. In addition, the ongoing Phase 2a study in China in patients with TNBC continues to accrue patients in the dose escalation phase, the primary objective of which is to determine the recommended Phase 2 dose in Chinese study subjects. This dose escalation phase is expected to reach the full accrual target in Q3 2017.
Dr. Alex Zukiwski, CASI's Chief Medical Officer, commented, "We continue to evaluate the maturing data including the biomarker analysis to determine the potential future development path in patients with TNBC. Identifying markers predictive of response to ENMD-2076 in patients with TNBC would be helpful to future development as a single agent, as well as consideration of any additional trials where ENMD-2076 could be combined with approved agents to increase clinical benefit."
Along with the investigators, the Company plans to present the study results at the next available opportunity.
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 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: 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 CFDA 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 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.
MARQIBO®, EVOMELA® and ZEVALIN® are proprietary to Spectrum Pharmaceuticals, Inc. and its affiliates.
CASI Pharmaceuticals, Inc.
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