EntreMed Announces Initiation Of Second Site For Phase 2 Trial In
Triple-Negative Breast Cancer
ROCKVILLE, Md., Jan. 4, 2013
ROCKVILLE, Md., Jan. 4, 2013 /PRNewswire/ --EntreMed, Inc. (Nasdaq: ENMD), a
clinical-stage pharmaceutical company, announced today the initiation of a
second site for its Phase 2 study of ENMD-2076 in triple-negative breast
cancer (TNBC). Kathy Miller, MD, Associate Professor at the Melvin and Bren
Simon Cancer Center at Indiana University serves as the investigator for the
study. Indiana University joins the University of Colorado Cancer Center
where the Phase 2 study is already underway. This 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.
Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer commented, "The primary
objective of this Phase 2 trial is to assess clinical benefits of ENMD-2076 in
TNBC patients. In addition, it will also test in a clinical setting the
correlation between patient responses to ENMD-2076 and p-53 based genomic
profiling predictive biomarker that was identified in pre-clinical studies by
Dr. Jennifer Diamond and her group at the University of Colorado Cancer
Center. This Phase 2 trial is therefore valuable to us and it may provide
critical guidance on our next phase of clinical trials. The study at our
first site is moving along well and we would like to express thanks to our
investigators and research staff for their dedication and support. We are
excited with the addition of Indiana University as a second site and Dr. Kathy
Miller as the principal investigator."
Dr. Ren continued, "The continued development of ENMD-2076 to address unmet
medical needs for an effective treatment of various types of cancer, including
triple-negative breast cancer, represents our commitment to the clinical
advancement of the ENMD-2076 oncology platform. We are evaluating several
other indications for further development, including sarcoma and ovarian
cancer among others. In addition, our wholly owned China subsidiary in
Beijing is fully operational and local product development, manufacturing and
regulatory activities are underway which will allow us to leverage both China
and US resources in our global drug development mission."
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 Aurora A and angiogenic kinase inhibitor for cancer, 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.
EntreMed, Inc. recently initiated a dual-institutional Phase 2 study of
ENMD-2076 in triple-negative breast cancer. Its second compound, 2ME2, has
been investigated in clinical trials in oncology patients, and is the subject
of a successful IND filing for clinical use to treat RA. Additional
information about EntreMed is available on the Company's web site at
www.entremed.comand in various filings with the Securities and Exchange
Commission (the SEC).
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. EntreMed, Inc. recently
initiated a Phase 2 study of ENMD-2076 in triple-negative breast 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.
SOURCE EntreMed, Inc.
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