ROCKVILLE, Md., May 11 EntreMed, Inc. (Nasdaq: ENMD), today announced the addition of Dana Farber/Harvard Cancer Center (DF/HCC) to the Phase 2 multi-center study entitled "A Phase 2 Study of Oral ENMD-2076 Administered to Patients with Platinum Resistant Ovarian Cancer." Ursula Matulonis, M.D., Associate Professor of Medicine, Dana-Farber Cancer Institute and Harvard Medical School, will serve as principal investigator.
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The study will be open at Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center, all of whom are members of the Dana-Farber/Harvard Cancer Center. The DF/HCC hospitals join Princess Margaret Hospital in Toronto as a clinical trial site. Additional participants are expected to be added later this quarter.
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The primary objective of the study will be to determine the progression free survival (PFS) rate of patients at six months. Patients with platinum resistant ovarian, fallopian or peritoneal cancer enrolled in the study will receive ENMD-2076 administered orally as a single agent once a day in 28-day cycles. A total of 60 patients are expected to be enrolled in the study.
"We are very excited to participate in the Phase 2 study of ENMD-2076 in recurrent ovarian cancer," said Dr. Matulonis. "It will be particularly interesting to determine the compound's potential in this difficult to treat patient population."
Carolyn F. Sidor, M.D., M.B.A., EntreMed Vice President and Chief Medical Officer commented on the site initiation, "We are pleased to have Dr. Matulonis and the physicians at DF/HCC participate in this Phase 2 study with ENMD-2076. DF/HCC is one of the two institutions who are participating in the Phase 1 study of ENMD-2076 in patients with various solid tumors, and we are delighted that the collaboration continues into Phase 2."
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. Preclinical studies with ENMD-2076 demonstrated significant antitumor activity, including tumor regression, in multiple solid and hematological malignancies. 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.
About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company committed to developing primarily ENMD-2076, a selective angiogenic kinase inhibitor, for the treatment of cancer. ENMD-2076 is currently in Phase 1 studies in advanced cancers, multiple myeloma, and leukemia and 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.
About Dana-Farber/Harvard Cancer Center (DF/HCC)
Dana-Farber/Harvard Cancer Center, a federally-designated comprehensive cancer center, harnesses the resources of Harvard University by bringing together the cancer research efforts of its seven member institutions: Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Children's Hospital Boston, Dana-Farber Cancer Institute, Harvard Medical School, Harvard School of Public Health, and Massachusetts General Hospital.
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.
