EntreMed, Inc. Announces FDA Has Granted Permission For Endostatin Protein
Clinical Trials to Begin
Health & Medical Writers
ROCKVILLE, Md--(BW HealthWire)--July 27, 1999--EntreMed, Inc.
(NASDAQ:ENMD) announced today that it has been notified by the US Food
and Drug Administration that "permission has been granted for the
Endostatin(tm) protein clinical trials to begin."
EntreMed's Investigational New Drug (IND) application for
Endostatin(tm) protein was submitted to the FDA on June 24th, 1999.
Permission to proceed with human clinical trials was received after
FDA officials reviewed EntreMed's IND application for 30 days.
With FDA permission to proceed now granted, and sufficient
Endostatin(tm) protein already manufactured to GMP standards and
vialed for human testing, EntreMed is now completing the final
requirements which include receipt of protocol approvals from the
Institutional Review Boards (IRBs) at each of the clinical trial
sites, and quality assurance of the vialed GMP material.
As previously announced, the first Phase I clinical trial to
begin human safety testing and evaluation of Endostatin(tm) protein
will be through Dana-Farber/Partners CancerCare, the joint-venture
between Dana-Farber Cancer Institute, Brigham and Women's, and
Massachusetts General Hospitals in Boston.
Two additional Phase I clinical trial sites, sponsored by the
National Cancer Institute (NCI), are the University of Texas M.D.
Anderson Medical Center in Houston, and the University of Wisconsin
Comprehensive Cancer Center in Madison.
Dr. John W. Holaday, EntreMed Chairman, President and Chief
Executive Officer commented: "In public statements over the past 12
months, we have indicated that the IND for Endostatin(tm) protein
would be filed in the third quarter of 1999. As a result of our
aggressive development schedule and the early completion of
preclinical testing, I am pleased to report that the Company was able
to file the IND in the second quarter, three months ahead of schedule.
We continue to advance our product candidates to the clinic with
expediency and efficiency, motivated by the belief that these
naturally-occuring inhibitors of angiogenesis may provide a new, less
toxic, resistance-free therapeutic option for cancer patients."
Rockville, Md.-based EntreMed, Inc., The Angiogenesis
Company(TM), is a leader in the field of antiangiogenesis research,
which involves the inhibition of abnormal blood vessel growth recently
associated with a broad range of diseases such as cancer and
atherosclerosis.
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--CF/ph*
CONTACT: EntreMed, Inc.
Mary P. Sundeen, Sr. Director, Corp. Communications,
301/738-2490
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