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EntreMed Initiates Crossover Bioavailability And Food Effect Study Of ENMD-2076 Dosage Form To Be Used For Pivotal/Registration Clinical Trials

ROCKVILLE, Md., July 29, 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 initiated a crossover bioavailability and food effect study of ENMD-2076.  The study is a single-blind, randomized, single-dose, crossover study with a food effect arm to investigate the safety and relative bioavailability of two dosage forms of ENMD-2076 administered as escalating doses in two cohorts of healthy subjects.  The study is expected to enroll approximately 29 healthy adult volunteers and will be conducted in Tempe, Arizona by a clinical research organization.  EntreMed anticipates the clinical portion of the study will be completed by year end, and that pharmacokinetic analysis will be completed in early 2014.

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

Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented, "The primary objective of this study is to compare the bioavailability and pharmacokinetic profile of two dosage forms of ENMD-2076 and to assess the effect of food on the bioavailability.  This crossover study will enable the company to satisfy the FDA's requirements on the formulated product of ENMD-2076 that can be used for our pivotal/registration clinical trials.  This study is another step towards the advancement of our ENMD-2076 drug development program." 



About ENMD-2076ENMD-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 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.



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