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EntreMed Announces Initiation Of Phase 2 Trial In Triple-negative Breast Cancer

ROCKVILLE, Md., July 25, 2012 /PRNewswire/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company, announced today the initiation of a dual-institutional Phase 2 study of ENMD-2076 in triple-negative breast cancer. Jennifer R. Diamond, MD at the University of Colorado serves as the principal investigator for the study. The 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.

(Logo:  http://photos.prnewswire.com/prnh/20010620/ENMDLOGO)

Jennifer R. Diamond, MD, stated, "Triple-negative breast cancer represents an aggressive breast cancer subtype which carries a high risk of developing distant metastasis.  It remains an area of unmet need in terms of effective anti-cancer agents with innovative patient selection strategies. We are encouraged by the data from the Phase 1 study of ENMD-2076 in patients with advanced solid tumors, including triple-negative breast cancer. ENMD-2076 has also demonstrated significant anti-tumor activity against preclinical models of breast cancer with more robust activity against triple-negative breast cancer alone or in combination with standard chemotherapies.  This single-agent Phase 2 study is designed to determine the activity of ENMD-2076 by the clinical benefit rate in patients with previously treated locally advanced or metastatic triple-negative breast cancer."

Ken Ren, Ph.D., EntreMed's Chief Executive Officer commented, "The development of ENMD-2076 to address the unmet medical need for an effective treatment of triple-negative breast cancer represents a part of our integrated initiatives in the clinical advancement of the ENMD-2076 oncology platform. ENMD-2076 is unique in its class and has demonstrated promising clinical activity across multiple oncology indications in our previous clinical trials. To maximize the value proposition of ENMD-2076, we are evaluating several of those indications as possible targets for further clinical trials while leveraging resources in both the US and China. Additionally, following the Phase 1 and Phase 2 results of ENMD-2076 in ovarian cancer, we are evaluating the next trial in this indication.  We will continue to execute on our clinical development plans this year and appreciate the support and encouragement of Dr. Diamond and our other investigators and clinical advisors. We are grateful not only to their collective expertise in specific oncology areas but also to their passion, commitment and contributions to bring ENMD-2076 to patients."

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 angiogenic kinase inhibitor, 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. 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.

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