EntreMed Announces Publication Of Preclinical Results For ENMD-2076 In Triple-negative Breast Cancer

    EntreMed Announces Publication Of Preclinical Results For ENMD-2076 In
                        Triple-negative Breast Cancer

Predictive biomarkers of sensitivity to ENMD-2076 published in Clinical Cancer
Research

PR Newswire

ROCKVILLE, Md., Nov. 26, 2012

ROCKVILLE, Md., Nov.26, 2012 /PRNewswire/ --EntreMed, Inc. (Nasdaq: ENMD), a
clinical-stage pharmaceutical company developing targeted therapeutics for the
treatment of cancer, announced today the publication of favorable results of a
preclinical study in breast cancer of its oral AuroraA/angiogenic kinase
inhibitor, ENMD-2076.

(Logo: http://photos.prnewswire.com/prnh/20010620/ENMDLOGO )

The article, entitled "Predictive Biomarkers of Sensitivity to the Aurora and
Angiogenic Kinase Inhibitor ENMD-2076 in Preclinical Breast Cancer Models"
reports evidence that ENMD-2076 exhibited robust anticancer activity against
breast cancer cell lines lacking expression of the estrogen receptor (ER),
progesterone receptor (PR) and without HER2‑amplification: a particularly
difficult to treat subtype termed "triple-negative" breast cancer (TNBC).
TNBC is associated with a shortened disease-free and overall survival at all
stages of diagnosis when compared to other breast cancer subtypes. Candidate
predictive biomarkers were also identified which may be useful in selecting
patients that are particularly sensitive to this compound, ENMD-2076, in the
future.

In this study, a diverse panel of twenty-nine breast cancer cell lines
representative of the clinically defined breast cancer subtypes were exposed
to ENMD-2076 and the effects on proliferation, apoptosis, and cell cycle
distribution were evaluated. ENMD-2076 demonstrated more robust activity
against cell lines of the TNBC subtype compared to the luminal and
HER2-amplified subtypes. This in vitro activity was confirmed in vivo, in
MDA-MB-468 and MDA-MB-231 TNBC xenografts. Baseline gene expression profiling
and pathway analysis of the panel revealed that p53 and G1/S cell cycle
pathways were upregulated in the more sensitive cell lines. Within the TNBC
subset itself, cell lines with a p53 mutation and increased p53 expression
were more sensitive to the cytotoxic and pro-apoptotic effects of ENMD-2076
exposure than cell lines with decreased p53 expression. This information
provides the basis for a predictive biomarker strategy to explore in future
clinical trials with ENMD-2076.

Dr. Jennifer R. Diamond of the University of Colorado School of Medicine, who
led the study, commented, "Triple-negative breast cancer is an aggressive
breast cancer subtype which carries a high risk of developing metastasis. A
major barrier to the successful treatment of metastatic TNBC is the lack of
effective targeted anti-cancer agents. Through this study, we show that
ENMD-2076 has activity against preclinical models of breast cancer with more
robust activity against TNBC. The study also supports further clinical
investigation of ENMD-2076 in patients with metastatic TNBC with an emphasis
on the continued development of p53-based predictive biomarkers."

Ken Ren, Ph.D., EntreMed's Chief Executive Officer further commented, "One of
the major challenges for the development of a target therapy for cancer is the
identification of a responsive subtype with a predictive biomarker. In our
previous Phase 1 study, we observed a patient with TNBC who had failed
multiple chemotherapy regimens then had clinically significant stabilization
of disease for 41 weeks after ENMD-2076 treatment. The benchmark of median
duration after first line therapy in such patients with metastasis is just 12
weeks. This pre-clinical study illustrated scientific insight into the
selective sensitivity of TNBC to ENMD-2076 with direct correlation to p53
mutation and over expression. It provides strong support for the rational of
our ongoing Phase 2 TNBC trial. Upon further confirmation clinically, it may
also provide guidance on future trials for patient selection, and may increase
the probability of success. We are continuing to enroll patients in the
ongoing Phase 2 trial and anticipate the initiation of a second site for this
trial soon. We remain on track with our clinical development activities and
expect our progress to accelerate in the coming months and year."

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. EntreMed, Inc. recently
initiated a Phase 2 study of ENMD-2076 in triple-negative breast cancer.
Additional information about EntreMed is available on the Company's website 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. 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.

COMPANY CONTACT:
Investor Relations
EntreMed, Inc.
240.864.2643
investorrelations@entremed.com

SOURCE EntreMed, Inc.

Website: http://www.entremed.com
 
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