EntreMed ENMD-2076 Phase 1 Data to Be Presented at ASCO Annual Meeting
May 15 2009 - 7:00AM
PR Newswire (US)
ENMD-2076 Clinical Program Adds Leukemia Clinical Study and Orphan
Drug Designation ROCKVILLE, Md., May 15 /PRNewswire-FirstCall/ --
EntreMed, Inc. (NASDAQ: ENMD), a clinical-stage pharmaceutical
company developing therapeutics for the treatment of cancer today
announced presentations for three of its clinical-stage drug
candidates at the American Society of Clinical Oncology (ASCO)
Annual Meeting to be held May 29 - June 2, 2009 in Orlando,
Florida. Presentations include both poster and discussion sessions
and are listed below. -- Poster Session: Friday, May 29, 2009 -
2:00 p.m. - 6:00 p.m. Abstract No.: 3520, "An open-label, dose
escalation, safety, and pharmacokinetic study of ENMD-2076
administered orally to patients with advanced cancer." --
Discussion Session: Friday, May 29, 2009 - 5:00 p.m. - 5:15 p.m.
"Angiogenesis Inhibitors: New Agents and New Combinations," Level
4, Valencia Room, W415D. -- Poster Session: Saturday, May 30, 2009
- 8:00 a.m. - 12:00 p.m. Abstract No.: 3562, "A single center,
open-label, dose escalation, safety, and pharmacokinetic study of
ENMD-1198 administered orally to patients with advanced cancer." --
Poster Session: Sunday, May 31, 2009 - 2:00 p.m. - 6:00 p.m.
Abstract No: 5577, "Phase 2 study of MKC-1 in patients with
metastatic or resistant epithelial ovarian cancer or advanced
endometrial cancer." (Logo:
http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO ) The Company
has further expanded its clinical development efforts for ENMD-2076
and has commenced a Phase 1 study in patients with relapsed or
refractory leukemia. The study will be conducted at the Princess
Margaret Hospital in Toronto, Ontario and Karen Yee, M.D., will
serve as Principal Investigator. Although the primary endpoints of
the study include defining the maximum tolerated dose (MTD) and
dose limiting toxicity (DLT) of ENMD-2076 administered orally in
patients with relapsed or refractory leukemia, the study will also
evaluate pharmacodynamic effects of ENMD-2076 by collaborating with
Dr. David Hedley, Department of Molecular Oncology, Ontario Cancer
Institute (OCI). Dr. Mark R. Bray, EntreMed Vice President,
Research commented, "We are very excited to be working with Dr.
Hedley and his staff, who have considerable experience in
evaluating the mechanistic effects of kinase inhibitors like
ENMD-2076 in cancer patients. The close proximity of EntreMed
scientific personnel based in Toronto to our clinical collaborators
at the OCI will facilitate our ability to obtain the maximum value
from this study and its correlative components." In addition, the
U.S. Food and Drug Administration (FDA) granted orphan drug
designation for ENMD-2076 for the treatment of ovarian cancer.
Several ovarian cancer patients participated in the ENMD-2076 Phase
1 study in solid tumors and will be included in the data
presentations at ASCO. Orphan drug is a designation by the Food and
Drug Administration indicating a therapy developed to treat
diseases that affect fewer than 200,000 persons in the United
States. Sponsors of drugs granted orphan designation qualify for
tax credit and marketing exclusivity incentives of the Orphan Drug
Act. Previously EntreMed had received orphan drug designation for
ENMD-2076 for multiple myeloma. EntreMed Vice President and Chief
Medical Officer, Carolyn F. Sidor, M.D., M.B.A., commented, "The
clinical development program for ENMD-2076 is expanding with the
addition of the myeloma clinical study announced earlier and with
this new study in patients with leukemia. Also, plans are underway
to expand the solid tumor study at the maximum tolerated dose of
ENMD-2076 to further define the objectives of safety,
pharmacokinetics and antitumor activity. We believe the current
clinical program allows us to quickly add new patients to establish
the potential of ENMD-2076 and provide a focus for Phase 2
development. These data serve as a foundation to continue
discussions with potential development partners for ENMD-2076."
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
demonstrate 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 Aurora A kinase
and other oncogenic proteins. Aurora kinases are key regulators of
mitosis (cell division), and are often over-expressed in human
cancers. ENMD-2076 targets a defined set of kinases, including
Flt-3 and FGFR3, which have been shown to play important roles in
the pathology of hematological cancers. About EntreMed EntreMed,
Inc. is a clinical-stage pharmaceutical company committed to
developing primarily ENMD-2076, a selective angiogenic kinase
inhibitor, for the treatment of cancer. ENMD-2076 is currently in
Phase 1 studies in advanced cancers and multiple myeloma. The
Company's other therapeutic candidates include MKC-1, an oral
cell-cycle regulator with activity against the mTOR pathway
currently in multiple Phase 2 clinical trials for cancer, and
ENMD-1198, a novel antimitotic agent currently in Phase 1 studies
in advanced cancers. The Company also has an approved IND
application for Panzem(R) in rheumatoid arthritis. Additional
information about EntreMed is available on the Company's web site
at http://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 (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 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; 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
http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO
http://photoarchive.ap.org/ DATASOURCE: 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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