ENMD NEWS posted this morning...
For anyone still following ENMD, look like more of the obvious to me...
Regards...
Company Press Release
EntreMed, Inc. Signs Letter of Intent for GMP Production of Angiostatin Protein
Protein Scale-Up Manufacturing Underway for Human Clinical Trials
ROCKVILLE, Md.--(BW HealthWire)--March 3, 1999--EntreMed, Inc. (Nasdaq:ENMD - news) 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(TM). EntreMed's success with Endostatin(TM) 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(TM) protein. Our experience in manufacturing complex proteins such as Endostatin(TM) 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(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. 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.
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