EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With China CFDA
To Expand Clinical Trial for Advanced Ovarian Clear Cell Carcinoma
ROCKVILLE, Md., Jan. 13, 2014 /PRNewswire/ — EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of diseases, announced today that it has moved to expand its Phase 2 clinical trial for its drug candidate ENMD-2076 in advanced ovarian clear cell carcinoma (OCCC) with the submission of a new drug global clinical trial application with China’s Food and Drug Administration (CFDA). The ongoing Phase 2 trial is currently being conducted at Princess Margaret Cancer Centre in Toronto, along with participation from up to seven additional cancer centers in Canada and the U.S.
This application is the Company’s third new drug global clinical trial application with the CFDA. The first was announced in January 2013 for triple-negative breast cancer, which is being conducted at the University of Colorado and at Indiana University. The second was announced in June 2013 for the advanced/metastatic soft tissue sarcoma trial, which is being conducted at Princess Margaret Hospital. More information about the Company’s clinical trials can be found at www.clinicaltrials.gov.
Ken K. Ren, Ph.D., EntreMed’s Chief Executive Officer, commented, “We are advancing our clinical trials in targeted patient populations in North America, while expanding the trials into China to reach our goal of achieving clinical inflection points more cost-effectively. This North America/China business model is compelling because it not only will enable us to develop more drugs with efficient resources, but also will accelerate product entry into China’s market at least three years earlier compared with more traditional approaches. In addition, the U.S. FDA recently has accepted the data from our crossover bioavailability study for ENMD-2076, thereby approving the use of ENMD-2076 in formulated dosage form for our clinical studies based on its pharmacokinetic equivalence to the non-formulated dosage form. This provides us with a significant advantage in future product manufacturing.”
Dr. Ren added, “We are actively pursuing in-licensing opportunities for additional drug candidates for development under this same global approach. We have further strengthened our internal product development capabilities in China with the recent establishment of an R&D Center in Beijing, and have added a technology leader with extensive large pharma experience in pharmaceutical technology and product development, along with a proven track record of bringing products from early stage proof-of-concept development to late-stage clinical trials.”
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 tumor cancers including ovarian, breast, liver, renal and sarcoma, as well as in leukemia and multiple myeloma, and is completing a Phase 2 trial for ovarian cancer. EntreMed is conducting a dual-institutional Phase 2 study of ENMD-2076 in triple-negative breast cancer, a Phase 2 study in advanced/metastatic soft tissue sarcoma, and a Phase 2 study in advanced ovarian clear cell carcinomas. ENMD-2076 has received orphan drug designation from the U.S. FDA for the treatment of ovarian cancer, multiple myeloma and acute myeloid leukemia.
EntreMed is a clinical-stage pharmaceutical company employing a drug-development strategy primarily in North America and China to develop targeted therapeutics for global markets. Its lead compound, ENMD-2076, a selective angiogenic kinase inhibitor, has completed several Phase 1 studies in solid tumors, multiple myeloma and leukemia, and is completing a multi-center Phase 2 study in ovarian cancer. EntreMed is conducting a Phase 2 study of ENMD-2076 in triple-negative breast cancer, a Phase 2 study of ENMD-2076 in advanced/metastatic soft tissue sarcoma, and a Phase 2 study of ENMD-2076 in advanced ovarian clear cell carcinomas. The Company is headquartered in Rockville, Maryland and has a wholly owned subsidiary in Beijing, China. Additional information about EntreMed is available on the Company’s web site at www.entremed.com and in various 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 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 our shares may be delisted from trading on the Nasdaq Capital Market; the volatility 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; declines in actual sales of Thalomid(®) resulting in reduced or no royalty payments; risks associated with our product candidates; risks associated with any early-stage products under development; the risk 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.
Kim Sutton Golodetz
SOURCE EntreMed, Inc.