EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases, today
announced the presentation of Phase 2 results for the capsule formulation
of one of its lead oncology drug candidates, Panzem(R) (2-methoxyestradiol
or 2ME2), in patients with relapsed and plateau phase multiple myeloma. The
data were presented at the American Society of Clinical Oncology (ASCO)
Annual Meeting being held this week in Chicago, Illinois. The study was
conducted at the Mayo Clinic and the Dana-Farber Cancer Institute with Dr.
Vincent Rajkumar and Dr. Paul Richardson as principal investigators,
respectively.
Results of the Phase 2 study demonstrated prolonged stable disease and
minor responses in patients receiving the original formulation of Panzem(R)
Capsules. Sixty patients with relapsed or plateau phase multiple myeloma
were enrolled in the study. Panzem(R) Capsules were well tolerated and did
not cause significant neuropathy (peripheral nerve damage),
myelosuppression (decreased bone marrow activity) or thromboembolic
disease. Progression free survival (PFS) rates were 24%, 17% and 11% for
all patients at 1, 2, and 3 years. Five patients continue to receive
Panzem(R) Capsules, including three patients with plateau phase disease who
have been on study for over four years without disease progression.
EntreMed has also received orphan drug designation for 2ME2 in multiple
myeloma from the FDA.
Panzem(R) is an orally-active small molecule that attacks tumor cells
through multiple mechanisms of action and blocks the development of new
blood vessels that feed tumor cells. One such mechanism is the upregulation
of death receptor 5 (DR5) leading to apoptosis. Panzem(R) also reduces
levels of IL-6, a known growth factor for myeloma cells. Panzem(R) Capsules
continue to be used by the five patients remaining on the study. An
improved oral liquid formulation, Panzem(R) NCD, is now being used in
multiple Phase 1 and 2 clinical studies. Panzem(R) NCD has been shown to
increase the exposure of 2ME2 in patients by 5 to 10 fold. Interim results
from two additional clinical studies using Panzem(R) NCD are also being
presented during the conference.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief
Medical Officer, commented, "We are encouraged by these results as they
demonstrate antitumor activity and represent a rationale for future studies
with Panzem(R) NCD in multiple myeloma patients. This is especially true
considering the higher drug levels possible with the NCD formulation. In
addition, since several patients have received Panzem(R) for years, the
data will help us build our safety profile to support additional oncology
uses and for our planned program in rheumatoid arthritis."
To view the poster presentation, visit the Recent Presentations section
of the Company's web site at entremed.
About Multiple Myeloma
Multiple myeloma is a type of cancer formed by cancerous plasma cells
in the blood. When plasma cells grow uncontrollably, they can form a tumor,
usually in the bone marrow. This tumor type is called myeloma, and if there
are many tumors, it is called multiple myeloma. The exact cause of multiple
myeloma is still unclear. Several risk factors associated with multiple
myeloma include age and gender, race, radiation exposure, family history,
and weight. The American Cancer Society estimates that approximately 19,000
new cases of multiple myeloma will be diagnosed in the United States in
2007, and approximately 11,000 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 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