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.
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.
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