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

EntreMed, Inc. 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-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 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. 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).