Did you see this: EntreMed in 4-yr R&D pact with National Cancer Institute
By Bridge News
New York--Apr 6--EntreMed Inc. entered a four-year research and development
pact with the National Cancer Institute. Entremed plans to work on development
of 2-methoxyestradiol, an anti-cancer agent and angiogenesis inhibitor.
* * *
The following is the text of today's announcement with emphasis added by
Bridge News. BridgeStation links to company data have been inserted at the end:
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 oral
ly 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(TM) protein, Angiostatin(R) protein, and mosu 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(TM), 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).
--30--LS/na*
CONTACT: EntreMed Inc., Rockville
Mary P. Sundeen, 301/738-2490
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Apr-06-1999 07:56 GMT
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