ENMD), a clinical-stage pharmaceutical company developing therapeutics for
the treatment of cancer and inflammatory diseases, announced that
Dana-Farber Cancer Institute has joined the University of Colorado Cancer
Center in conducting a Phase 1 study of ENMD-2076 in advanced cancer
patients. Dr. Geoffrey Shapiro, Dana-Farber Cancer Institute, and Dr. Wells
Messersmith, University of Colorado Cancer Center, will serve as
co-principal investigators for the study.
Safety and tolerability of orally administered ENMD-2076 in refractory
cancer patients will be assessed in this Phase 1 study. A secondary
objective for the study will be to determine a dose-dependent response to
treatment with ENMD-2076 through the evaluation of pharmacokinetic
parameters.
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 both 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.
Carolyn F. Sidor, MD, MBA, EntreMed Vice President and Chief Medical
Officer commented on the study, "Both clinical trial sites are now
enrolling and treating patients with our selective kinase inhibitor. We
believe that this product candidate has substantial potential as both a
single agent and in combination with other approved cancer drugs. ENMD-2076
is unique-in-class because it not only inhibits Aurora A selectively, it
also inhibits a cluster of kinases that are important for tumor growth,
particularly growth factor receptors critical to angiogenesis. ENMD-2076
has potent antitumor activity in multiple preclinical models, including
both solid tumors and hematological cancers."
James S. Burns, EntreMed President & Chief Executive Officer commented,
"Further development of ENMD-2076 is consistent with both our focus on
investing behind oncology drug candidates with strong single-agent activity
and our continuing interest in kinase inhibitors. In keeping with our 2008
goals of cash preservation and rigorous resource management, we intend to
pay the $2 million Phase 1 milestone to Miikana shareholders in shares of
EntreMed common stock. Our goals for this program over the next twelve
months are to complete the clinical trial in solid tumor patients, initiate
a clinical trial in patients with hematological cancers, and secure a
pharmaceutical partner to help accelerate the development of ENMD-2076."
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 http://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).
EntreMed, Inc.
http://www.entremed.com
View drug information on Thalomid.
