EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases, today
announced the commencement of a Phase 2 combination study with Panzem(R)
NCD (2-methoxyestradiol or 2ME2) and Temodar(R) (temozolomide) in patients
with recurrent glioblastoma multiforme (GBM). Annick Desjardins, M.D.,
FRCPC, Associate in Medicine at the Preston Robert Tisch Brain Tumor Center
at Duke University Medical Center will serve as principal investigator. The
purpose of the single center, open-label study will be to determine
progression free survival (PFS), pharmacokinetics and safety in GBM
patients receiving orally- administered Panzem(R) NCD in combination with
Temodar(R).
Panzem(R) NCD is an orally-administered anticancer agent that attacks
tumor cells through multiple mechanisms of action (MOA) and blocks the
development of new blood vessels that feed tumor cells. Panzem's MOAs
include apoptosis (programmed cell death), tumor cell cycle inhibition at
the G2/M phase of mitosis, and disruption of angiogenesis through the
inhibition of hypoxia inducible factor-1 alpha (HIF-1alpha), a protein
required for angiogenesis and cell survival under stress. By these
mechanisms, Panzem(R) has the potential to attack cancer cells through
multiple pathways that affect the formation and replication of tumor cells,
and can interrupt the formation of blood vessels that nourish tumor cells
and sustain tumor growth.
Panzem(R) NCD is currently being evaluated in multiple Phase 2 studies
in patients with a variety of cancers including GBM, prostate cancer,
ovarian cancer, carcinoid tumors, and renal cell carcinoma. Panzem(R) NCD
has been well-tolerated with an acceptable safety profile, allowing it to
be combined with other anticancer therapies such as Temodar(R).
Glioblastoma is an aggressive and highly vascularized disease. EntreMed
has previously presented preclinical data demonstrating that combination
treatment with Panzem(R) and Temodar(R) resulted in tumor regression
compared to either agent alone in a glioblastoma model.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief
Medical Officer, commented, "Commencement of this Phase 2 study represents
a significant milestone in the clinical development plan for Panzem(R) NCD.
The rationale for this combination study is based on preclinical results
demonstrating substantial tumor regression with Panzem(R) both alone and in
combination with Temodar(R) in GBM models. We are currently conducting a
single-agent Phase 2 clinical study with Panzem(R) NCD in GBM patients at
the Duke Medical Center. The goal of the new trial is to determine the
potential therapeutic benefit of combining Panzem(R) NCD with the current
standard of care, Temodar(R). We anticipate presenting interim clinical
data from the single-agent study of Panzem(R) NCD in GBM patients at the
ASCO annual meeting to be held June 1-5, 2007."
For more information on this study, visit the Clinical Trials section
of the Company's web site at entremed.
Temodar(R) is a registered trademark of its owner and not of EntreMed,
Inc. Panzem(R) is a registered trademark of EntreMed, Inc.
About Glioblastoma
Approximately 40,000 cases of primary central nervous system (CNS)
cancers are diagnosed each year in the United States, of which 17,000 are
malignant tumors. Malignant CNS tumors cause approximately 13,000 deaths
per year, or about three-fourths of the new annual malignant cases.
Glioblastoma multiforme (GBM), also known as grade IV astrocytoma, is the
most common and aggressive type of primary brain tumor. GBMs account for
approximately 52% of all primary brain tumors. The tumor forms in the glial
(supportive) tissue of the brain and invades adjacent tissue. The tumor
cells do not spread throughout the body and symptoms are caused by the
tumor invading the brain. These tumors have significant regions of hypoxia
and are highly dependent on angiogenesis for growth.
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 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