EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases, today
announced commencement of a multi-center study with its drug candidate,
MKC-1, in non-small cell lung cancer (NSCLC) patients. The lead institution
for this Phase 1/2, open label, dose escalation study will be the Indiana
University Cancer Center in Indianapolis, Indiana. Nasser H. Hanna, M.D.,
Assistant Professor, Department of Medicine, Division of
Hematology/Oncology at IUCCI, will serve as Principal Investigator. MKC-1
is being evaluated currently in Phase 1 and 2 clinical studies against
breast cancer and in patients with leukemia.
The objective of the Phase 1 portion of this study will be to assess
the safety and maximum tolerated dose of MKC-1 when administered orally in
combination with pemetrexed (Alimta(R)). Alimta(R) is a multi-targeted
antifolate, which blocks the activity of folic acid and is approved for the
treatment of metastatic NSCLC.
The Phase 2 component of this study will assess the antitumor activity
and progression free survival (PFS) in up to 60 patients with non-small
cell lung cancer. Patients whose disease has progressed following initial
therapy may be eligible to enroll. Patients will receive orally
administered MKC-1 in combination with pemetrexed (Alimta(R)). A secondary
endpoint of the Phase 2 study will be to evaluate other parameters of
antitumor activity including response duration and overall survival.
MKC-1 is a novel, orally active cell cycle inhibitor with in vitro and
in vivo efficacy against a wide range of human solid tumor cell lines,
including multi-drug resistant cell lines. MKC-1 has demonstrated
broad-acting antitumor effects, showing tumor growth inhibition or
regression in multiple animal models, including paclitaxel-resistant
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. These effects are consistent with a mechanism resulting
from MKC-1 binding to multiple intracellular targets, including tubulin and
the importin beta proteins. The importin beta family of proteins plays a
critical role in nuclear transport and cell division.
Dr. Nasser Hanna commented, "We look forward to initiating this
important study to determine the effects that MKC-1 in combination with
Alimta(R) has against lung cancer." Carolyn F. Sidor, M.D., M.B.A.,
EntreMed's Vice President and Chief Medical Officer, further commented, "We
continue to expand our development program for MKC-1. The NSCLC clinical
trial represents the third clinical study initiated this year and our first
clinical trial combining MKC-1 with an approved therapeutic agent. Dr.
Hanna, the study's principal investigator, and his colleagues at the
Indiana University Cancer Center participated in the initial clinical study
of MKC-1 as a single agent in NSCLC patients. By combining MKC-1 with
Alimta(R), we hope to improve the clinical benefit over either agent given
alone in patients who have failed prior chemotherapy."
For information on this study, visit the Clinical Trials section of the
Company's web site at entremed/.
Alimta(R) is a registered trademark of its owner and is not a
registered trademark of EntreMed, Inc.
About Non-Small Cell Lung Cancer
For treatment purposes, lung cancer is classified clinically as small
cell or non-small cell lung cancer (NSCLC). NSCLC is a disease in which the
cells of the lung tissues grow uncontrollably and form tumors and
represents approximately 87% of all primary lung cancers. The tumors can
reduce the capacity of the lungs or block the movement of air through the
bronchi in the lungs. The American Cancer Society estimates that
approximately 174,000 new lung cancer cases will be diagnosed in 2006,
resulting in approximately 162,000 deaths.
About EntreMed
EntreMed, Inc. (Nasdaq: ENMD) is a clinical-stage pharmaceutical
company developing therapeutic candidates primarily for the treatment of
cancer and inflammation. Panzem(R) (2-methoxyestradiol or 2ME2), the
Company's lead drug candidate, is currently in Phase 2 clinical trials for
cancer, as well as in preclinical development for rheumatoid arthritis.
MKC-1, an oral cell cycle regulator, is in Phase 2 studies for metastatic
breast cancer. ENMD-1198, a novel tubulin binding agent, is also in Phase 1
studies in advanced cancers. 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 website
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 integration of
Miikana and its 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/