EntreMed Files New Drug Clinical Trial Application For ENMD-2076 With China SFDA To Advance Global Development Strategy

 EntreMed Files New Drug Clinical Trial Application For ENMD-2076 With China
                 SFDA To Advance Global Development Strategy

PR Newswire

ROCKVILLE, Md., Jan. 7, 2013

ROCKVILLE, Md., Jan.7, 2013 /PRNewswire/ --EntreMed, Inc. (Nasdaq: ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of cancer, announced today that EntreMed has submitted a new drug
clinical trial application with China's State Food and Drug Administration
(SFDA) for its proprietary drug candidate, ENMD-2076, to conduct global
clinical trials in triple-negative breast cancer patients.

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

Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented, "We are very
pleased with SFDA's acceptance of our application package and look forward to
working with the SFDA to move the process forward towards approval. SFDA's
approval of our application would pave the way for us to conduct global
clinical trials in China and advance our ongoing Phase 2 triple-negative
breast cancer trial currently underway at the University of Colorado and
Indiana University.

"Our filing with SFDA represents an important milestone for us. As a
clinical-stage drug development company, competition in patient recruitment,
time, and costs can be challenging when advancing clinical programs. We
address this by building a value-added platform via a joint US-China drug
development model that will enable us to do the trials with lower study costs
and faster patient recruitment. The data we obtain may be used to support
both global drug development and China import drug registration as
appropriate."

Dr. Ren continued, "We will also pursue developing ENMD-2076 in other
indications where activity has been shown, including ovarian cancer, sarcoma
and liver cancer, based on our prioritized product development plan. We
believe positive results from these efforts will add value to our patients,
shareholders, as well as to the company.

"In addition, we have initiated local manufacturing and pre-clinical
activities of ENMD-2076 in China to target specific unmet medical needs, such
as hepatocellular carcinoma, which could support a new drug trial application
with SFDA. Our local development activities demonstrate EntreMed's commitment
to develop a strong presence in the Chinese market, which has been projected
to become the second largest pharmaceutical market in coming years. We
believe we are on track with our development plan and are grateful to our
shareholders for their enthusiasm, patience, and long term support."

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 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 was the subject
of a successful IND filing for clinical use to treat RA in 2006. 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 (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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