EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases, today
announced commencement of a Phase 1 study with its clinical-stage drug
candidate, MKC-1, in patients with hematological (blood) malignancies. The
study will be conducted at the University of Texas MD Anderson Cancer
Center in Houston, Texas. Francis J. Giles, M.D., Professor, Department of
Leukemia at the MD Anderson Cancer Center, will serve as Principal
Investigator. MKC-1 is also being evaluated currently in a Phase 2 clinical
study in patients with metastatic breast cancer.
Patients with relapsed or refractory leukemias will be enrolled. At the
present time, there is a need for more effective therapies for patients
with relapsed or refractory leukemias. MKC-1 has shown good activity
against a variety of hematological cell lines leading to interest in a
clinical trial in patients with leukemias.
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. In addition to the strong preclinical activity of MKC-1 towards
solid tumor lines, the lack of neuropathy and cardiotoxicity seen in
clinical trials suggests that MKC-1 may also be valuable in the treatment
of hematological cancers.
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 in multiple cell lines. These effects are consistent with
a mechanism resulting from MKC-1 binding to its intracellular targets,
tubulin and the importin beta proteins. The importin beta family of
proteins plays a critical role in nuclear transport and cell division.
Carolyn F. Sidor, M.D., M.B.A., EntreMed's Vice President and Chief
Medical Officer, commented, "Initiation of this clinical trial represents
continued progress on our clinical development plan for MKC-1. This is the
first clinical study where MKC-1 will be given to patients with
hematological cancers. These patients may be particularly suited for MKC-1
treatment based on MKC-1's mechanisms of action. MD Anderson is well-known
for its expertise in hematological cancers and Dr. Giles has substantial
experience in evaluating new therapies in this patient population."
For information on this study, visit the Clinical Trials section of the
Company's web site at entremed.
About Hematological Malignancies
Hematological malignancies are cancers that affect blood, bone marrow
and lymph nodes. As the blood, bone marrow and lymph nodes are intimately
connected through the immune system, a disease affecting one of the three
will often affect the other. Chromosomal translocations are a common cause
of these diseases, which leads to a different approach in diagnosis and
treatment. Diseases characterized as hematological malignancies include
leukemia, lymphoma and multiple myeloma.
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/