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

Rockville, MD /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.

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.

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.