(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases,
announced that it has commenced a multi-center Phase 2 clinical trial with
MKC-1 in patients with advanced pancreatic cancer. The primary objectives
of this study will be to determine the antitumor activity of
orally-administered MKC-1 in unresectable or metastatic pancreatic cancer
patients who have failed at least one prior chemotherapy regimen. The study
will also assess the safety, tolerability and overall median survival time
of pancreatic cancer patients treated with MKC-1. Massachusetts General
Hospital Cancer Center is the lead institution for the study and Eunice
Kwak, M.D., Ph.D., Assistant in Medicine, Tucker Gosnell Center for
Gastrointestinal Cancers, will serve as the principal investigator.
MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and
in vivo efficacy against a broad range of human solid tumor cell lines,
including multi-drug resistant cell lines. Prior preclinical studies have
demonstrated that MKC-1 has significant antitumor activity as both a single
agent and in combination with an approved epidermal growth factor/epidermal
growth factor receptor (EGF/EGFR) inhibitor in pancreatic cancer models.
MKC-1 has also demonstrated broad-acting antitumor effects, including tumor
growth inhibition or regression, in multiple preclinical models. MKC-1 has
been shown to inhibit mitotic spindle formation, prevent chromosome
segregation in the M-phase (mitosis) of the cell cycle, and induce
apoptosis.
Carolyn F. Sidor, M.D., M.B.A., EntreMed Vice President and Chief
Medical Officer, commented on the study, "Pancreatic cancer patients
continue to need more effective and better tolerated treatment options.
MKC-1 has shown good activity in preclinical testing against pancreatic
tumors, supporting its use in this patient population. Positive results
from this clinical trial will provide the basis for designing future
randomized Phase 2 studies. With this clinical trial initiation, we are now
evaluating MKC-1 as a single agent or in combination in patients with
pancreatic cancer, metastatic breast cancer, non- small cell lung cancer
(NSCLC), and leukemia."
About Pancreatic Cancer
Pancreatic cancer is the abnormal cell growth in the tissue of the
pancreas. The pancreas is an organ about six inches in length which is
located behind the stomach, next to the small intestine. The pancreas
produces enzymes that aide in the digestion and absorption of food. Unless
pancreatic cancer is detected early, it is difficult to control. At the
present time, there is no effective screening for pancreatic cancer and,
because the pancreas is hidden by other organs, it is difficult to
diagnosis. Pancreatic cancer is the fourth leading cause of cancer death in
the United States. The American Cancer Society estimates that approximately
37,000 Americans will be diagnosed with cancer of the pancreas in 2007,
resulting in approximately 33,000 deaths.
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) is also in preclinical development 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.
entremed
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