ROCKVILLE, Md., March 30, 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 the China Food and Drug Administration (CFDA) has approved the Company's application to conduct a Phase 2 global clinical trial in ovarian clear cell carcinoma (OCCC) patients for its proprietary drug candidate ENMD-2076.
The approval will allow CASI to expand its ongoing Phase 2 OCCC trial currently underway in multiple centers in North America with Princess Margaret Cancer Centre in Toronto, Canada as the lead institution. This will be the Company's third approval of a global Phase 2 clinical trial in China, the first being for advanced triple-negative breast cancer in which the first patient was enrolled last week at the Cancer Hospital of Chinese Academy of Medical Science in Beijing and the second being for advanced soft tissue sarcoma. More information about the three trials can be found at www.clinicaltrials.gov.
Ken K. Ren, Ph.D., CASI's Chief Executive Officer, commented, "Our excitement about this trial is two-fold. First, CFDA's approval of this third application supports our commitment to our global development strategy for ENMD-2076 to include China as an important component under our US/China development model. Second, we will be able to explore the therapeutic potential of ENMD-2076 in the Chinese OCCC patient population which may show a distinct sensitivity profile."
Rong Chen, M.D., Ph.D., CASI's Chief Medical Officer, stated, "The Phase 2 trial in North America is progressing as planned under the direction of Dr. Amit M. Oza, who is the principal investigator of the trial at Princess Margaret Cancer Centre. We are very pleased that we can now expand the trial into China with the recruitment of more patients. Data from this China trial will be evaluated in conjunction with data being collected in the Canadian/US trials in an effort to further advance the development of ENMD-2076."
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 Captisol-Enabled™ (propylene glycol-free) melphalan (CE melphalan) 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.
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.
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® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates. Captisol-Enabled™ is the trademark property of its owner.