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EntreMed Commences Phase 2 Trial For ENMD-2076 In Ovarian Clear Cell Carcinomas



     EntreMed Commences Phase 2 Trial For ENMD-2076 In Ovarian Clear Cell
                                  Carcinomas

PR Newswire

ROCKVILLE, Md., Oct. 31, 2013

ROCKVILLE, Md., Oct. 31, 2013 /PRNewswire/ -- EntreMed, Inc. (NASDAQ: ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of a variety of cancers, announced today the commencement of a
multi-center Phase 2 study entitled "Phase II Study of Oral ENMD-2076
Administered to Patients with Ovarian Clear Cell Carcinomas."  The study is
led by principal investigator Amit M. Oza, MD at Princess Margaret Cancer
Centre in Toronto, Canada with participation of up to seven additional cancer
centers in Canada and the United States.  More information about the clinical
trial can be found at www.clinicaltrials.gov.  

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

Amit M. Oza, MD, principal investigator of the study, commented, "Ovarian
clear cell carcinomas (OCCC) account for approximately 5-13% of all epithelial
ovarian cancers and compared to other subtypes, are associated with poorer
prognosis and can be resistant to conventional platinum-based chemotherapy. 
It presents a considerable clinical challenge and there is a need to develop
new therapeutics in the management of this disease.  ENMD-2076 has
demonstrated single agent activity in tumor models of multiple cancers
including ovarian cancer.  In a recent Phase 2 trial where ENMD-2076 was
administered to platinum-resistant recurrent ovarian cancer patients, some
OCCC patients had prolonged disease control, suggesting that it may be
effective in this subset of patients. We want to explore this further.  The
purpose of this study is to examine the response and PFS rates of ENMD-2076 in
this difficult to treat patient population.  We look forward to working
closely with EntreMed and colleagues from other sites in this Phase 2 trial."

Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer commented, "We are very
pleased to have Dr. Oza lead this trial.  Dr. Oza was a principal investigator
in our Phase 2 study in platinum resistant ovarian cancer and has been
instrumental in advancing our development program targeting this indication.
 The cumulative evidence has indicated the potential effectiveness of a
combined anti-angiogenic and anti-Aurora A targeted approach in OCCC, and we
believe ENMD-2076 presents strong clinical and scientific rationale for the
treatment of this subset of patient population.  This trial will provide us
with more insight into the drug's clinical activities and its correlation with
biomarkers."

Dr. Ren further commented, "Together with our trials in triple negative breast
cancer and soft tissue sarcoma, this is the third clinical trial we have
initiated for ENMD-2076 under our US/China development model.  We intend to
expand the trial into China once we have it underway in Canada and the US.
 Our goal is to reach a clinical inflection point using a cost-effective
approach that combines speed, quality and lower costs, in order to maximize
the value proposition of ENMD-2076. We are confident that we will reach this
goal."

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, multiple myeloma, and is currently completing a Phase
2 trial for ovarian cancer.  EntreMed is currently conducting a Phase 2 study
of ENMD-2076 in triple-negative breast cancer, a Phase 2 study in
advanced/metastatic soft tissue sarcoma, and expecting to initiate a Phase 2
study in ovarian clear cell carcinoma.  ENMD-2076 has received orphan drug
designation from the 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 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, a
Phase 2 study of ENMD-2076 in advanced/metastatic soft tissue sarcoma, and is
expecting to initiate a Phase 2 study in ovarian clear cell carcinoma.  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).

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
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