EntreMed's ENMD-2076 Demonstrates Significant Anti-Cancer Activity in Multiple Myeloma Preclinical Models
Study Results Published in British Journal of Haematology
ROCKVILLE, Md., July 13 /PRNewswire-FirstCall/ -- EntreMed, Inc. (NASDAQ: ENMDD) , today announced the publication of preclinical data for its Phase 2 oncology drug candidate, ENMD-2076 an Aurora A/angiogenic kinase inhibitor, which demonstrated significant activity against multiple myeloma (MM) cell lines and in MM models in vivo. Results of the study, conducted by EntreMed's collaborator, Sherif Farag, M.D., Ph.D., and colleagues at the Indiana University School of Medicine, were published in the on-line version of the British Journal of Haematology on June 15, 2010 and are scheduled to be published in print in the August 1, 2010 issue. Dr. Farag is the Principal Investigator for the ongoing Phase 1 study with ENMD-2076 in multiple myeloma patients. The Company recently initiated a Phase 2 study for ENMD-2076 in ovarian cancer patients. Ovarian cancer was selected as the initial Phase 2 indication based on results from the Phase 1 study in patients with solid tumors where the clinical benefit of ENMD-2076 was observed in this patient population. Six sites are participating in the Phase 2 study and all are actively recruiting patients.
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In the recently published preclinical data, ENMD-2076 was shown to
have significant cytotoxicity against MM cell lines as well as
against primary MM cells taken from human patients, with minimal
toxicity seen towards haematopoietic progenitor cells, which are
essential for the production of normal blood cells. ENMD-2076 was
observed to exert its activity through multiple mechanisms
important to MM growth and survival, including inhibition of the
phosphoinositide 3-kinase/AKT pathway, and downregulation of
X-linked inhibitor of apoptosis seen as early as six hours after
treatment. G2/M cell cycle arrest and inhibition of the Aurora A
and B kinases were seen after 24 to 48 hours of exposure. In murine
models implanted with H929, a human plasmacytoma cell line, oral
treatment resulted in dose-dependent inhibition of tumor growth
with concomitant reduction in mechanism-specific markers of
ENMD-2076 activity including phospho-histone H3, Ki-67,
angiogenesis, and phospho-FGFR3. These data on ENMD-2076's
mechanism of action provide additional support for ENMD-2076's
potential therapeutic applicability in a broad range of oncology
indications. ENMD-2076 has been the subject of multiple Phase 1
studies and is currently in a multi-center Phase 2 study in ovarian
cancer patients.
In addition to the publication of these preclinical data, Dr.
Sherif Farag's laboratory at the Division of Hematology and
Oncology, Department of Medicine, Indiana University School of
Medicine and the Indiana University Melvin and Bren Simon Cancer
Center, has been awarded a research grant for $319,550 sponsored by
the National Cancer Institute to continue his efforts to assess the
mechanisms of action of ENMD-2076 and its potential use as a
therapeutic to treat MM, an incurable cancer with current
treatment.
Dr. Mark R. Bray, Vice President Research at EntreMed commented,
"Dr. Farag's work has generated important additional insights into
the mechanism of action of our multi-kinase inhibitor. ENMD-2076 is
shown to target multiple myeloma cells through several mechanisms
that are vital to their growth and survival. Data from Dr. Farag's
laboratory expands and validates our knowledge regarding how
ENMD-2076 acts to kill cancer cells, and thereby increases our
understanding of how best to continue to utilize the compound in
the clinic to treat patients. We are very encouraged by the data
generated and the correlation of these findings with our clinical
work and will continue to advance our Phase 2 development of
ENMD-2076."
"We are pleased to have these preclinical results published as they
further support ENMD-2076's potential to treat patients with
hematological and solid tumors," commented Dr. Carolyn F. Sidor,
EntreMed's Vice President and Chief Medical Officer. "Additional
preclinical evaluations, as well as data complied from our ongoing
clinical studies, provide further insight into the scope of
ENMD-2076's activity and aide in the process of selecting
additional Phase 2 indications."
About ENMD-2076
ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor
with a unique kinase selectivity profile and multiple mechanisms of
action. Preclinical studies with ENMD-2076 demonstrated significant
antitumor activity, including tumor regression, in multiple solid
and hematological malignancies. ENMD-2076 has been shown to inhibit
a distinct profile of angiogenic tyrosine kinase targets in
addition to the Aurora A kinase. Aurora kinases are key regulators
of mitosis (cell division), and are often over-expressed in human
cancers. ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases
which have been shown to play important roles in the pathology of
several cancers. While ENMD-2076 is currently in a Phase 2 trial in
ovarian cancer, preclinical and clinical activities are ongoing in
assessing the compound's applicability in other forms of
cancer.
About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company committed
to developing ENMD-2076, a selective angiogenic kinase inhibitor,
for the treatment of cancer. ENMD-2076 is currently in a
multi-center Phase 2 study in ovarian cancer and in several Phase 1
studies in solid tumors, multiple myeloma, and leukemia. Additional
information about EntreMed is available on the Company's web site
at www.entremed.com 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, 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 the risk that we
may be unable to continue as a going concern as a result of our
inability to raise sufficient capital for our operational needs;
the possibility that we may be delisted from trading on the Nasdaq
Capital Market; the volatility of our common stock; risks relating
to the need for additional capital and the uncertainty of securing
additional funding on favorable terms; the failure to consummate a
transaction to monetize the royalty stream for any reason,
including our inability to obtain the required third-party
consents; declines in actual sales of Thalomid® resulting in
reduced revenues; 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,
including delays to the commencement of such 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).
CONTACT:
Ginny Dunn
Associate Director, Corporate Communications & Investor
Relations
EntreMed, Inc.
240.864.2643
Photo:
http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO
Source: EntreMed, Inc.
CONTACT: Ginny Dunn, Associate Director, Corporate
Communications &
Investor Relations of EntreMed, Inc., +1-240-864-2643
Web Site: http://www.entremed.com/
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Posted: July 2010
