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 - 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.
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.
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