EntreMed Initiates Second Site in ENMD-2076 Phase 2 Ovarian Cancer Study
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.
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."
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.
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
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CONTACT: Ginny Dunn Associate Director, Corporate Communications & Investor Relations EntreMed, Inc. 240.864.2643
SOURCE EntreMed, Inc.
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