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.
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.