posted
April 15, 1999
Entremed, Inc. Signs Cooperative Research
and Development Agreement (CRADA) With the National Cancer Institute
to Advance Studies of an Orally Active Antitumor and Antiangiogenic
Agent 2-Methoxyetsradiol
ROCKVILLE, Md April 6, 1999/Wired Bird at PSA Rising/
- EntreMed, Inc. (NASDAQ:ENMD) today announced that it is advancing the
development of 2-methoxyestradiol (2ME2), a potent
anticancer agent and angiogenesis inhibitor, through a four-year Cooperative
Research and Development Agreement (CRADA) with the National Cancer Institute
(NCI).
Under the terms of the agreement, EntreMed scientists will provide 2ME2
to the NCI for collaborative studies in preclinical pharmacology, toxicology,
and anticipated clinical trials. EntreMed will also continue its comprehensive
research efforts to demonstrate the effects of 2ME2
on tumor inhibition while preparing GMP material for clinical trials.
Together with the NCI, the Company will design, review, and interpret
the results of the preclinical studies required for the preparation and
submission of an Investigational New Drug (IND) application to the Food
and Drug Administration.
Dr. Shawn J. Green, EntreMed's Vice President of Discovery Research, commented
on the Company's first small molecule product candidate: "2ME2
is orally active at inhibiting the growth of metastatic and primary cancerous
tumors in experimental rodent models. In these preclinical models, 2ME2
has shown no overall toxicity at therapeutically effective doses."
Dr. Green continued, "While an estrogen derivative, studies of 2ME2
failed to show any of the several effects associated with hormone treatment,
such as uterine growth, carcinogenesis, or inhibition of white blood cell
formation. Further, in sharp contrast to conventional chemotherapeutics,
2ME2 targets rapidly growing cells with
relative high specificity and does not kill non-dividing cells."
2ME2 is the first product
candidate from EntreMed to attack both compartments of cancer, the tumor
cells and their blood supply. In addition to its marked effects on stopping
the growth of malignant cells, 2ME2 also
acts as a potent inhibitor of angiogenesis by restriciting development
of the blood vessels that transport life-sustaining nutrients to tumors.
2ME2 has shown clear antitumor activity
in vivo and in vitro at the National Cancer Institute, and
in EntreMed-sponsored research in independent laboratories throughout
the United States and in Europe.
Dr. Edward Sausville, Associate Director for the Developmental Therapeutics
Program of the National Cancer Institute, commented on the 2ME2
research underway: "The NCI is pleased to be collaborating with EntreMed
to advance to the clinic this attractive antitumor compound which potentially
can target both the tumor cell and the endothelial cell."
Dr. John W. Holaday, EntreMed Chairman, President and Chief Executive
Officer discussed the agreement, "EntreMed continues to derive an
enormous benefit from its collaborations with the NCI, allowing us to
advance the development of several angiogenesis inhibitors including thalidomide,
Endostatin protein, Angiostatin® protein, and most recently
2-methoxyestradiol. With the signing of this CRADA with the NCI, we expect
to complete the preclinical phase of 2ME2
development this year."
EntreMed and the NCI have been collaborating on the development of 2ME2
since1997 when they signed a CRADA Letter of Intent (LOI) to explore manufacturing
processes and preclinical safety evaluations for 2ME2.
The Letter of Intent allowed immediate initiation of collaborative studies
while negotiations were ongoing for the CRADA. The antiangiogenic properties
of 2-methoxyestradiol, a naturally occurring metabolite of estrogen, were
first described in 1994 by Dr. Robert D'Amato and others from the laboratory
of Dr. Judah Folkman at Children's Hospital, Boston. Subsequent studies
at EntreMed, and a number of other institutions and universities, revealed
several biological properties associated with 2ME2
which make it a distinctly attractive cancer therapeutic candidate.
Rockville, Md.-based EntreMed, Inc., The Angiogenesis Company ,
is a leader in the field of antiangiogenesis research, which studies the
inhibition of abnormal blood vessel growth recently associated with a
broad range of diseases. The Company's strategy is to accelerate development
of its core technologies through collaborations and sponsored research
programs with university medical departments, research companies and government
laboratories. Rockville, Md.-based EntreMed, Inc., The Angiogenesis CompanyTM,
is a leader in the field of antiangiogenesis research, which studies the
inhibition of abnormal blood vessel growth recently associated with a
broad range of diseases. The Company's strategy is to accelerate development
of its core technologies through collaborations and sponsored research
programs with university medical departments, research companies and government
laboratories.
For further information, please visit the EntreMed web site at www.entremed.com.
Statements herein that
are not descriptions of historical facts are forward-looking and subject
to risk and uncertainties. Actual results could differ materially from
those currently anticipated due to a number of factors, including those
set forth in the Company's Securities and Exchange Commission filings
under "Risk Factors," including risks relating to the early
stage of products under development; uncertainties relating to clinical
trials; 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).
SOURCE Entremed,
Inc.
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