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posted
March 23, 1999
Entremed, Inc. Signs Letter of Intent
For GMP Production of Angiostatin®
Protein Scale-Up Manufacturing Underway for Human
Clinical Trials
ROCKVILLE, Md. March 3, 1999/Wired Bird at PSA Rising/ EntreMed,
Inc. (NASDAQ:ENMD) announced today that it has signed a letter of
intent with Covance Biotechnology Services, Inc., of Research Triangle
Park, NC, to provide large-scale GMP (Good Manufacturing Practices)
production of Angiostatin® protein for further preclinical studies
and early human clinical trials.
Since 1995, EntreMed has been engaged in the development of Angiostatin®
protein at its Rockville, Maryland facility. EntreMed's development
efforts for Angiostatin® protein have focused solely upon the production
of the protein in the Pichia pastoris yeast expression system. In
1998, EntreMed scientists produced over 50 biologically active lots
of Angiostatin®protein up to the 100-liter scale. Now, through
the collaboration with Covance, GMP production of the protein is
anticipated to advance to the 2,000-liter fermentation scale by
mid-year.
Dr. Edward R. Gubish, Senior Vice President of Research and Development
for EntreMed, commented: "Angiostatin® is the first natural antiangiogenic
factor licensed by EntreMed. Since its discovery in 1994, over 92
publications have confirmed its potent antiangiogenic effects in
preclinical models of cancer and angiogenic diseases. We anticipate
that our relationship with Covance will enable the production of
sufficient clinical grade Angiostatin® to meet our aggressive development
timetable."
EntreMed and Covance have already begun the work necessary for the
timely set-up and production of Angiostatin® protein in the Pichia
yeast expression system.
In 1997, EntreMed scientists first reported that Pichia-derived
recombinant human Angiostatin® protein inhibited primary and metastatic
cancer in preclinical testing (Cancer Research 57, 1329-1334, April
1, 1997, Sim et al). In 1998, EntreMed scientists first reported
on a newly defined version of Angiostatin® that was smaller, less
complex, and yet still conferred all of the potent tumor inhibitory
activity of the larger molecule (Abstracts of the 89th Annual Meeting
of the AACR, March 1998, Liang et al). It is that version of the
molecule that is now being scaled-up for human testing.
Dr. John W. Holaday, EntreMed Chairman, President and Chief Executive
Officer commented on the collaboration: "We are fortunate to have
two potent antiangiogenic proteins under concurrent development,
Angiostatin® and Endostatin. EntreMed's success with Endostatin
production has greatly facilitated the expansion of our relationship
with Covance to include the GMP production of Angiostatin®. Both
of our Pichia-derived proteins have been shipped to investigators
throughout the United States and in Europe who then confirmed the
potent antiangiogenic properties of these molecules in rigorous
models of cancer."
Bryan Lawlis, Ph.D., Chairman of Covance Biotechnology Services,
commented on the agreement: "Covance is encouraged by our success
to date in the timely production of appropriate quantities of Endostatin
protein. Our experience in manufacturing complex proteins such as
Endostatin will serve us well in the development of Angiostatin®
as well. Covance is pleased to work with EntreMed once again."
Rockville, Md.-based EntreMed, Inc., The Angiogenesis Company,
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. 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).
Key Term Used In This Release Pichia pastoris: A methylotropic
yeast that has the capability of secreting large quantities of foreign
proteins into the fermentation broth in which it survives. Pichia
pastoris is an industry accepted production system already being
used for several protein-based biopharmaceutical agents currently
in clinical trials.
SOURCE Entremed,
Inc.
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