Home Press Releases EntreMed Achieves a Key Milestone Through Initiation of ENMD-2076 Clinical Program
EntreMed Achieves a Key Milestone Through Initiation of ENMD-2076 Clinical Program
Apr 09,2008

EntreMed Achieves a Key Milestone Through Initiation of ENMD-2076 Clinical Program

Selective Kinase Inhibitor Phase 1 Trial in Advanced Cancer Patients

ROCKVILLE, Md., April 9, 2008—EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases, today
announced that it has commenced a Phase 1, dose-escalation study for its
selective kinase inhibitor, ENMD-2076, in advanced cancer patients. Dr. Wells
Messersmith, University of Colorado Cancer Center, will serve as co-principal
investigator for the study. Additional centers are expected to join Colorado
as study sites this quarter.

ENMD-2076 is a novel, selective kinase inhibitor with potent activity
against Aurora A and tyrosine kinases linked to the promotion of cancer and
inflammatory diseases. ENMD-2076 acts through multiple pathways resulting in
antiproliferative activity and the inhibition of angiogenesis. ENMD-2076 has
demonstrated substantial, dose-dependent efficacy as a single agent in
multiple preclinical models, including tumor regression in breast, colon, and
leukemia models. Importantly, ENMD-2076 is an oral agent that has shown an
acceptable toxicity profile in preclinical studies without cardiovascular
toxicity.
The Phase 1 study will assess safety and tolerability of orally
administered ENMD-2076 in refractory cancer patients. In addition,
pharmacokinetics will be assessed to determine a dose-dependent response to
treatment with ENMD-2076.
Carolyn F. Sidor, M.D., M.B.A., EntreMed’s Vice President and Chief
Medical Officer, commented on the study, “Commencement of this Phase 1 study
marks the achievement of a critical milestone in our clinical development
program and further supports our strategy of focusing on orally-administered,
small molecule drugs with multiple mechanisms of action. Data from preclinical
studies with ENMD-2076 demonstrate its significant antitumor potential as a
single agent in a variety of tumor types. Through this Phase 1 study, we
expect to not only determine ENMD-2076’s safety profile and appropriate Phase
2 dosing schedule, but which tumor types may be better suited for this
compound. We plan to initiate a second Phase 1 study in patients with
hematological cancers later this year.”
James S. Burns, EntreMed President & Chief Executive Officer commented,
“ENMD-2076 is an exciting selective kinase inhibitor with potent single agent
activity that has induced tumor regression in multiple preclinical models.
ENMD-2076, developed internally, is consistent with our focus on investing
behind oncology drug candidates with strong single-agent activity and with our
continuing interest in selective kinase inhibitors. In parallel with the
clinical trial, we will seek a pharmaceutical or biotech partner to help
accelerate the development of our novel selective kinase inhibitor.”
The administration of ENMD-2076 to the first patient in this important
Phase 1 study will trigger a milestone payment by EntreMed pursuant to
EntreMed’s acquisition of Miikana Therapeutics, Inc. in January 2006. Under
the terms of the merger agreement with Miikana, the dosing of the first
patient triggers a $2 million payment to the former Miikana stockholders,
either in cash or shares of EntreMed common stock.

About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company developing
therapeutic candidates primarily for the treatment of cancer and inflammation.
MKC-1 is currently in multiple Phase 2 clinical trials for cancer. MKC-1 is an
oral cell-cycle regulator with activity against the mTOR pathway. ENMD-1198, a
novel antimitotic agent, and ENMD-2076, a selective kinase inhibitor, are in
Phase 1 studies in advanced cancers. The Company also has an approved IND
application for Panzem(R) in rheumatoid arthritis. EntreMed’s goal is to
develop and commercialize new compounds based on the Company’s expertise in
angiogenesis, cell-cycle regulation and inflammation—processes vital to the
treatment of cancer and other diseases, such as rheumatoid arthritis.
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.

Forward Looking Statements
This release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act with respect to the outlook for
expectations for future financial or business performance (including the
timing of royalty revenues and future R&D expenditures), strategies,
expectations and goals. Forward-looking statements are subject to numerous
assumptions, risks and uncertainties, which change over time. Forward-looking
statements speak only as of the date they are made, and no duty to update
forward-looking statements is assumed. Actual results could differ materially
from those currently anticipated due to a number of factors, including those
set forth in Securities and Exchange Commission filings under “Risk Factors,”
including risks relating to the need for additional capital and the
uncertainty of additional funding; variations in actual sales of Thalomid(R),
risks associated with the Company’s product candidates; the early-stage
products under development; results in preclinical models are not necessarily
indicative of clinical results, uncertainties relating to preclinical and
clinical trials; success in the clinical development of any products;
dependence on third parties; future capital needs; and risks relating to the
commercialization, if any, of the Company’s proposed products (such as
marketing, safety, regulatory, patent, product liability, supply, competition
and other risks).