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EntreMed Commences Phase 2 Trial For ENMD-2076 In Ovarian Clear Cell Carcinomas
Date:10/31/2013

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

 


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