Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,516.27 98.74 0.68%
TOPIX 1,173.37 6.78 0.58%
HANG SENG 22,760.24 64.23 0.28%

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



 EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With
     China CFDA To Expand Clinical Trial For Advanced/Metastatic Sarcoma

PR Newswire

ROCKVILLE, Md., June 27, 2013

ROCKVILLE, Md., June 27, 2013 /PRNewswire/ -- EntreMed, Inc. (Nasdaq: ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of a variety of cancers, announced today that it has submitted a new
drug global clinical trial application with the China Food and Drug
Administration (CFDA) for its proprietary oncology drug candidate, ENMD-2076. 
The purpose of the application is to expand the Company's Phase 2 clinical
trial in advanced/metastatic sarcoma which currently is being conducted at
Princess Margaret Hospital.  This submission is the Company's second new drug
global clinical trial application with the CFDA.  The first application when
approved will expand the Company's Phase 2 clinical trial for triple-negative
breast cancer which currently is being conducted at the University of Colorado
and Indiana University.  More information about the clinical trials can be
found at www.clinicaltrials.gov.

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

Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented, "We are
advancing our global development program in sarcoma because we believe that
ENMD-2076, with its unique dual targets of Aurora A and VEGFR, may provide
therapeutic benefits to the targeted patient population with unmet medical
needs. We are excited about expanding the trial and are encouraged by the
support from our investigators.  We look forward to working with the CFDA to
move our application forward towards approval.  Regarding our application for
triple-negative breast cancer, we are currently working with the Center for
Drug Evaluation of CFDA on the technical review and have begun laying out the
groundwork for the trial, which is targeted to be launched by the fourth
quarter of this year after approval is received.

Dr. Ren continued, "We are pleased with the continued execution of our
integrated US-China drug development plan.  Expanding our trials into China
will enable us to explore the potential of ENMD-2076 at an accelerated pace
due to faster patient recruitment and lower study costs, while obtaining data
that will lead to advanced global drug development as well as China import
drug registration."

"In parallel with the advancement of our ENMD-2076 program," Dr. Ren further
continued, "we are also evaluating additional drug candidates to add to our
pipeline, with emphasis on compounds that have the potential for gaining
widespread market acceptance globally or in China and for which development
can be carried out cost-effectively under our global drug development
strategy."

About EntreMed

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

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 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; 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
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement