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 its aurora
kinase/angiogenesis inhibitor, ENMD-2076.
ENMD-2076 is a novel, dual-acting, kinase inhibitor with potent
activity against Aurora A and tyrosine kinases linked to promoting 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 xenograft 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 effects.
Carolyn F. Sidor, MD, MBA, EntreMed Vice President and Chief Medical
Officer commented on the IND, "Acceptance of the Investigational New Drug
application for ENMD-2076 initiates the clinical program for our first
compound that targets kinases. This is an exciting class of compounds with
several recently approved in oncology indications. ENMD-2076 is unique in
class because it not only inhibits Aurora A selectively over Aurora B, it
also inhibits a number of other kinases important in the growth of tumors
and, in particular, growth factor receptors critical to angiogenesis.
ENMD-2076 has potent antitumor activity in multiple preclinical models
including both solid tumors and hematological cancers. As such, we plan to
initiate several clinical studies with ENMD-2076 that include Phase 1
trials in both solid and hematological cancers in 2008."
James S. Burns, EntreMed President & CEO commented, "The IND for
ENMD-2076 represents an important milestone for EntreMed. This compound has
shown significant single-agent activity, including tumor regression in
multiple animal models. Moving ENMD-2076 forward into clinical development
is consistent with our strategy of investing preferentially behind small
molecule, orally-administered, multi-mechanism product candidates with
potent single-agent antitumor activity and strong intellectual product
coverage. Our goal is to commence clinical trials for ENMD-2076 and, in
parallel, seek a development partner to help us accelerate the development
of what I believe is an exciting oncology opportunity for EntreMed."
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. Panzem(R) NCD is currently in multiple Phase 2 trials for
cancer. Additionally, ENMD- 1198, a novel tubulin-binding agent, is in
Phase 1 studies in advanced cancers. Panzem(R) (2-methoxyestradiol) is also
in multiple Phase 2 studies in oncology patients. The Company has approved
IND applications for Panzem(R) in rheumatoid arthritis, and ENMD-2076, a
dual-acting Aurora-angiogenesis inhibitor, 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.
entremed