EntreMed, Inc. Announces Initiation of Second Site for Phase 2 Trial in Triple-Negative Breast Cancer
ROCKVILLE, Md., Jan. 4, 2013 /PRNewswire/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company, announced today the initiation of a second site for its Phase 2 study of ENMD-2076 in triple-negative breast cancer (TNBC). Kathy Miller, MD, Associate Professor at the Melvin and Bren Simon Cancer Center at Indiana University serves as the investigator for the study. Indiana University joins the University of Colorado Cancer Center where the Phase 2 study is already underway. This study is sponsored by EntreMed and is supported by a grant from the National Cancer Institute. More information about the clinical trial can be found at www.ClinicalTrials.gov.
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Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer commented, "The primary objective of this Phase 2 trial is to assess clinical benefits of ENMD-2076 in TNBC patients. In addition, it will also test in a clinical setting the correlation between patient responses to ENMD-2076 and p-53 based genomic profiling predictive biomarker that was identified in pre-clinical studies by Dr. Jennifer Diamond and her group at the University of Colorado Cancer Center. This Phase 2 trial is therefore valuable to us and it may provide critical guidance on our next phase of clinical trials. The study at our first site is moving along well and we would like to express thanks to our investigators and research staff for their dedication and support. We are excited with the addition of Indiana University as a second site and Dr. Kathy Miller as the principal investigator."
Dr. Ren continued, "The continued development of ENMD-2076 to address unmet medical needs for an effective treatment of various types of cancer, including triple-negative breast cancer, represents our commitment to the clinical advancement of the ENMD-2076 oncology platform. We are evaluating several other indications for further development, including sarcoma and ovarian cancer among others. In addition, our wholly owned China subsidiary in Beijing is fully operational and local product development, manufacturing and regulatory activities are underway which will allow us to leverage both China and US resources in our global drug development mission."
About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company employing a drug development strategy primarily in the United States and China to develop targeted therapeutics for the global market. Its lead compound, ENMD-2076, a selective Aurora A and angiogenic kinase inhibitor for cancer, has completed several Phase 1 studies in solid tumors, multiple myeloma, and leukemia, and is currently completing a multi-center Phase 2 study in ovarian cancer. EntreMed, Inc. recently initiated a dual-institutional Phase 2 study of ENMD-2076 in triple-negative breast cancer. Its second compound, 2ME2, has been investigated in clinical trials in oncology patients, and is the subject of a successful IND filing for clinical use to treat RA. Additional information about EntreMed is available on the Company's web site at www.entremed.com and in various filings with the Securities and Exchange Commission (the SEC).
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 tumor cancers, leukemia, and multiple myeloma. ENMD-2076 is currently completing a Phase 2 trial for ovarian cancer. EntreMed, Inc. recently initiated a Phase 2 study of ENMD-2076 in triple-negative breast cancer.
Forward Looking Statements
This 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 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; 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 royalty payments; risks associated with our product candidates; any early-stage products under development; 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 ("SEC"), which are available at www.sec.gov.
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