Phase 1 Trial Supported by Preclinical Data Presented at the American Society of Hematology Meeting
ROCKVILLE, Md., Dec. 9 /PRNewswire-FirstCall/ -- EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases, today
announced that it has initiated a Phase 1 study of ENMD-2076 in refractory
multiple myeloma patients. The study will be conducted at the Indiana
University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana. Dr.
Sherif Farag, Associate Professor, Department of Medicine, will serve as
principal investigator.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )
Primary objectives for the dose escalation study include determining the
maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ENMD-2076
when administered orally once a day in patients with multiple myeloma who are
refractory to other drug therapy. The study will also assess the safety,
tolerability, pharmacodynamic effects and activity of ENMD-2076 in this
patient population.
Preclinical data supporting the clinical evaluation of ENMD-2076 alone and
in combination in multiple myeloma were presented by Dr. Farag earlier this
week at the American Society of Hematology Annual Meeting in San Francisco,
CA. ENMD-2076 was shown to induce rapid apoptosis (cell death) in multiple
myeloma cell lines in vitro. Significant dose-dependent antitumor activity
with minimal toxicity was also induced in vivo when ENMD-2076 was administered
as a single agent in multiple myeloma models. Combination studies with
ENMD-2076 and lenalidomide (Revlimid(R)) in vitro indicated synergistic
cytotoxic activity towards several human multiple myeloma cell lines.
ENMD-2076 was shown, both in vitro and in vivo, to have minimal toxicity
towards human and murine hematopoietic progenitor cells, which are essential
for maintenance of an active immune system.
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 Aurora A kinase and other oncogenic proteins.
Aurora kinases are key regulators of mitosis (cell division), and are often
over-expressed in human cancers. In addition, ENMD-2076 is relatively
selective for the Aurora A isoform in comparison to Aurora B.
