EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With China CFDA

 EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With
                                  China CFDA

To Expand Clinical Trial for Advanced Ovarian Clear Cell Carcinoma

PR Newswire

ROCKVILLE, Md., Jan. 13, 2014

ROCKVILLE, Md., Jan.13, 2014 /PRNewswire/ --EntreMed, Inc. (Nasdaq: ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of diseases, announced today that it has moved to expand its Phase 2
clinical trial for its drug candidate ENMD-2076 in advanced ovarian clear cell
carcinoma (OCCC) with the submission of a new drug global clinical trial
application with China's Food and Drug Administration (CFDA). The ongoing
Phase 2 trial is currently being conducted at Princess Margaret Cancer Centre
in Toronto, along with participation from up to seven additional cancer
centers in Canada and the U.S.

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

This application is the Company's third new drug global clinical trial
application with the CFDA. The first was announced in January 2013 for
triple-negative breast cancer, which is being conducted at the University of
Colorado and at Indiana University. The second was announced in June 2013 for
the advanced/metastatic soft tissue sarcoma trial, which is being conducted at
Princess Margaret Hospital. More information about the Company's clinical
trials can be found at www.clinicaltrials.gov.

Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented, "We are
advancing our clinical trials in targeted patient populations in North
America, while expanding the trials into China to reach our goal of achieving
clinical inflection points more cost-effectively. This North America/China
business model is compelling because it not only will enable us to develop
more drugs with efficient resources, but also will accelerate product entry
into China's market at least three years earlier compared with more
traditional approaches. In addition, the U.S. FDA recently has accepted the
data from our crossover bioavailability study for ENMD-2076, thereby approving
the use of ENMD-2076 in formulated dosage form for our clinical studies based
on its pharmacokinetic equivalence to the non-formulated dosage form. This
provides us with a significant advantage in future product manufacturing."

Dr. Ren added, "We are actively pursuing in-licensing opportunities for
additional drug candidates for development under this same global approach. We
have further strengthened our internal product development capabilities in
China with the recent establishment of an R&D Center in Beijing, and have
added a technology leader with extensive large pharma experience in
pharmaceutical technology and product development, along with a proven track
record of bringing products from early stage proof-of-concept development to
late-stage clinical trials."

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 including ovarian, breast, liver, renal and sarcoma, as well as
in leukemia and multiple myeloma, and is completing a Phase 2 trial for
ovarian cancer. EntreMed is conducting a dual-institutional Phase 2 study of
ENMD-2076 in triple-negative breast cancer, a Phase 2 study in
advanced/metastatic soft tissue sarcoma, and a Phase 2 study in advanced
ovarian clear cell carcinomas. ENMD-2076 has received orphan drug designation
from the U.S. FDA for the treatment of ovarian cancer, multiple myeloma and
acute myeloid leukemia.

About EntreMed

EntreMed is a clinical-stage pharmaceutical company employing a
drug-development strategy primarily in North America and China to develop
targeted therapeutics for global markets. 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 completing a
multi-center Phase 2 study in ovarian cancer. EntreMed is conducting a Phase
2 study of ENMD-2076 in triple-negative breast cancer, a Phase 2 study of
ENMD-2076 in advanced/metastatic soft tissue sarcoma, and a Phase 2 study of
ENMD-2076 in advanced ovarian clear cell carcinomas. The Company is
headquartered in Rockville, Maryland and has a wholly owned subsidiary in
Beijing, China. Additional information about EntreMed is available on the
Company's web site at www.entremed.com and in various filings with the U.S.
Securities and Exchange Commission.

Forward Looking Statements

This news 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 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 our shares 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 or future candidates; 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 or no royalty payments; risks associated with our product
candidates; risks associated with any early-stage products under development;
the risk 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, which are available at
www.sec.gov.

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

INVESTOR CONTACT:
LHA
Kim Sutton Golodetz
212.838.3777
kgolodetz@lhai.com

SOURCE EntreMed, Inc.

Website: http://www.entremed.com
 
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