EntreMed Announces FDA Acceptance Of IND Application For Panzem(R) In Rheumatoid Arthritis

EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases,
announced that the U.S. Food and Drug Administration (FDA) has accepted its
Investigational New Drug (IND) application for Panzem(R)
(2-Methoxyestradiol or 2ME2) in rheumatoid arthritis (RA).


Rheumatoid arthritis (RA) is a chronic inflammatory disease
characterized by a proliferating synovium (joint lining), aberrant
angiogenesis, and progressive joint damage. Panzem(R) is a small molecule
metabolite of 17beta-estradiol which, in its purified form, has
antiproliferative, apoptotic, and antiangiogenic activity. These properties
make it of particular interest in various diseases characterized by
abnormal cellular proliferation and angiogenesis.



In three distinct preclinical treatment models, oral administration of
Panzem(R) demonstrated antiarthritic activity when treatment was initiated
following disease progression. In these therapeutic intervention models,
arthritic activity was attenuated and joint damage arrested as assessed by
histology or radiography. When Panzem(R) was administered early following
disease initiation, there was a dose-dependent inhibition of arthritic
activity (measuring evident edema and inflammation) and, in one model, a
delay in the onset of disease. Furthermore, using an early intervention
model, Panzem(R) combined well with methotrexate, a current standard of
care RA treatment, resulting in additive antiarthritic activity. The
results of these studies demonstrate that Panzem(R) is a DMARD (disease
modifying antirheumatic drug) that inhibits the principal symptoms of the
disease, including cartilage lesions, bone resorption, cellular
infiltration, and pannus formation.



Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief
Medical Officer, commented, "The cross over of agents used to treat cancer
into the treatment of patients with RA is well established with
methotrexate being the mainstay of RA therapy. Panzem(R) is a potentially
safe, orally-administered, small molecule drug candidate that could
contribute to the treatment paradigm for patients with RA. Based on
Panzem(R)'s demonstrated safety profile and activity in oncology patients,
its mechanism of action, and its activity in preclinical RA models, we
believe that Panzem(R) will be of considerable interest to clinicians as a
potential treatment for RA."



James S. Burns, President & CEO, also commented, "Acceptance of the IND
for Panzem(R) in RA represents the completion of a key development
milestone and adds another asset to our pipeline. Our strategy moving
forward will be to initiate early clinical trials internally and then seek
a development partner for larger multicenter clinical trials."
















About Rheumatoid Arthritis



Rheumatoid arthritis affects over 2 million American adults, of which
about two-thirds of them are women. The disease, characterized by pain,
stiffness, swelling, and deformity can become debilitating. Within 5 years
of diagnosis, a third of patients are no longer working, and within 10
years, half of the patients have substantial functional disability. RA can
shorten life expectancy by 5-10 years.



Rheumatoid arthritis (RA), one of the most common forms of arthritis,
is a systemic disease characterized by inflammation of the membrane lining
of the joint, which causes pain, stiffness, redness, swelling, and loss of
function in the joint. The inflamed joint lining, called the synovium,
releases enzymes that destroy bone and cartilage, causing the joint to lose
its shape and alignment. This process can result in joint pain, loss of
movement, and deformity. DMARDs are drugs that have the ability to slow
down disease progression in rheumatoid arthritis.



About EntreMed



EntreMed, Inc. is a clinical-stage pharmaceutical company developing
therapeutic candidates primarily for the treatment of cancer and
inflammation. Panzem(R) NCD (2-methoxyestradiol or 2ME2) is currently in
multiple Phase 2 clinical trials for cancer. MKC-1, an oral cell-cycle
regulator, is in multiple Phase 1 and 2 studies for cancer. ENMD-1198, a
novel tubulin-binding agent, is in Phase 1 studies in advanced cancers.
Panzem(R) has an approved IND for rheumatoid arthritis, and ENMD-2076, a
dual-acting Aurora-angiogenesis inhibitor, is in preclinical development
for cancer. 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 entremed 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).


EntreMed, Inc.

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