EntreMed (ENMD) Initiates Phase 2 Trial In Advanced/Metastatic Soft Tissue Sarcoma

ROCKVILLE, Md., Jan. 23, 2013 /PRNewswire/ — EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company, announced today the initiation of a single-center Phase 2 study entitled “A Phase 2 Study of Oral ENMD-2076 Administered to Patients with Advanced/Metastatic Soft Tissue Sarcoma” at Princess Margaret Hospital where the study is led by Malcolm Moore, MD and Albiruni R.A. Razak, MD.  The study is sponsored by Princess Margaret Cancer Centre. More information about the clinical trial can be found at www.clinicaltrials.gov.

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Albiruni R.A. Razak, MD, commented on the study, “Soft tissue sarcomas (STS) are diverse mesenchymal tumors that commonly affect patients in the prime of life.  The prognosis for patients with advanced/metastatic sarcoma remains poor and there are limited options for their treatment.  The median disease progression-free survival (PFS) for those patients is less than two months without treatment or less than five months with treatments currently available. This is certainly an area of unmet medical need.  The primary objective of this Phase 2 study is to evaluate the safety and efficacy of ENMD-2076 in advanced/metastatic STS patients with the 6 month PFS rate as the end point of the study.  We will also perform biomarker correlative studies that may define patients with a superior/inferior progression free survival. A number of pre-clinical and clinical investigations have provided encouraging results for the use of ENMD-2076 in the treatment of various types of cancer, including sarcoma.  We believe the co-inhibition of Aurora kinase A and angiogenesis would render ENMD-2076 an attractive and logical treatment for sarcoma.”

Ken K. Ren, Ph.D., EntreMed’s Chief Executive Officer commented, “We are excited about the initiation of this trial.  We believe ENMD-2076 has good potential in the treatment of sarcoma along with other oncology indications.  In our Phase 1 trial in solid tumors, we had one patient with advanced/metastatic sarcoma relapse after multiple lines of previous therapies, however after being treated with ENMD-2076, the patient had prolonged disease PFS for 21 months.  This Phase 2 trial will enable us to explore the potential of ENMD-2076 for this indication further. We look forward to our continued advancement and development of ENMD-2076 as an oncology platform.”

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 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, Inc. recently announced the initiation of a Phase 2 study of ENMD-2076 in triple-negative breast cancer and the initiation of a Phase 2 study of ENMD-2076 in advanced/metastatic soft tissue sarcoma.  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 dual-institutional 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.

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EntreMed, Inc.
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