EntreMed's ENMD-2076 Demonstrates Clinical Activity in Recurrent, Platinum-Resistant Ovarian Cancer Patients

ROCKVILLE, Md., June 3, 2011 /PRNewswire/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer today announced the presentation of clinical data for its Phase 2 study with ENMD-2076 in platinum-resistant ovarian cancer patients.   The data were presented by the principal investigator for the study, Dr. Ursula A. Matulonis, medical director of gynecologic oncology at Dana-Farber Cancer Institute and associate professor of medicine, Harvard Medical School, during a poster discussion session at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3 - 7, 2011 in Chicago, Illinois.

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The trial was an open-label, single-arm, multi-center-study of ENMD-2076 dosed orally as a single agent in patients with platinum-resistant recurrent ovarian, peritoneal or tubal cancer.  The study was conducted at six sites in the United States and Canada and included Dana-Farber Cancer Institute, Indiana University Melvin & Bren Simon Cancer Center, University of Chicago Medical Center, Memorial Sloan-Kettering Cancer Center, University of Colorado Cancer Center, and Princess Margaret Hospital.  Sixty-four patients were enrolled of which 57 were evaluable at the time of the presentation.  The primary endpoint for the study was progression-free survival rate at six months.  Secondary end-points include response rate, duration of response, and overall survival.  

ENMD-2076 demonstrated clinical activity when administered daily orally as a single agent.  Interim data from 57 evaluable patients showed a six-month progression free survival rate of 19%.  Of the evaluable patients, four patients achieved a partial response and 30 patients achieved stable disease as measured by RECIST v1.1. Median overall survival has not yet been reached.  The side effect profile was consistent with activity against ENMD-2076's targets, in particular, VEGFR2 and Aurora A.  Studies to evaluate potential markers of ENMD-2076 in this patient group are ongoing.  

Dr. Matulonis commented on the results of the study, "ENMD-2076 has demonstrated impressive anti-cancer activity in platinum-resistant ovarian cancer which is notoriously difficult to treat, and these patients have few options."  

EntreMed's chief medical officer, Carolyn F. Sidor, M.D., M.B.A., added, "These results are very encouraging as they support further development of ENMD-2076 and also help us clarify its developmental path in ovarian cancer.  We are currently designing the next clinical trial in this indication and look forward to opportunities to make ENMD-2076 available to ovarian cancer patients in the future."

Presentation Logistics

Poster Session: Friday, June 3, 2011 – 2:00 p.m. – 6:00 p.m. (CDT) Abstract No.: 5021
Title: A Phase 2 Study of ENMD-2076 in platinum-resistant ovarian cancer Poster Board: 10, Location: E450a

Discussion Session: Friday, June 3, 2011 – 5:00 p.m. – 6:00 p.m. (CDT), Location: E354b

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 I clinical trials in solid tumor cancers, leukemia, and multiple myeloma.  While ENMD-2076 is currently in a Phase 2 trial in ovarian cancer, preclinical and clinical activities are ongoing in assessing the compound's applicability in other forms of cancer.

To view a copy of the presentation, visit the Company's website at www.entremed.com.

About EntreMed

EntreMed, Inc. is a clinical-stage pharmaceutical company committed to developing ENMD-2076, a selective angiogenic kinase inhibitor, for the treatment of cancer.  ENMD-2076 is currently in a multi-center Phase 2 study in ovarian cancer and in several Phase 1 studies in solid tumors, multiple myeloma, and leukemia.  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.

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 those set forth in Securities and Exchange Commission filings under "Risk 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; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the failure to consummate a transaction to monetize the royalty stream for any reason, including our inability to obtain the required third-party consents; declines in actual sales of Thalomid^® resulting in reduced revenues; risks associated with the Company's product candidates; the 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; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). 

CONTACT:
Ginny Dunn
Associate Director, Corporate Communications & Investor Relations
EntreMed, Inc.
240.864.2643

SOURCE EntreMed, Inc.