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Biotech / Medical : EntreMed (ENMD) -- Ignore unavailable to you. Want to Upgrade?

To: Don Dorsey who wrote (1946)	7/8/1999 1:01:00 PM
From: Don Dorsey	Read Replies (1) \| Respond to of 2135

EntreMed, Inc. Signs Contract Manufacturing Agreement for GMP Production of Angiostatin Protein; Protein Manufacturing Underway for Human Clinical Trials Business Editors/Health/Medical Writers ROCKVILLE, Md.--(BW HealthWire)--July 8, 1999--EntreMed, Inc. (NASDAQ:ENMD) announced today that it has signed a contract with Covance Biotechnology Services, Inc., of Research Triangle Park, NC, to provide GMP (Good Manufacturing Practices) production of Angiostatin(R) protein for Phase I human clinical studies projected to commence early next year. Angiostatin(R) protein, a naturally-occurring antiangiogenic substance, was discovered in 1994 by Drs. Judah Folkman and Michael O'Reilly of Children's Hospital, Boston. In preclinical studies in mice, Angiostatin(R) protein has repeatedly inhibited the growth of a variety of metastatic and primary cancerous tumors, with no drug resistance or toxicity noted. EntreMed and Covance began technology transfer for the production of Angiostatin(R) protein in the first quarter of this year. With the technology transfer process now complete, EntreMed and Covance have jointly demonstrated success in numerous small and medium-scale fermentation runs. Larger GMP fermentations of Angiostatin(R) protein at the 2,000 liter scale are scheduled to commence at Covance early this quarter. Under the terms of the agreement, Covance will produce enough recombinant human Angiostatin(R) protein for the Phase I clinical trials as well as further preclinical studies. Dr. John W. Holaday, EntreMed Chairman, President and Chief Executive Officer commented on the contract with Covance: "After EntreMed's initial evaluation of five separate recombinant expression systems in 1995 and 1996, the Pichia pastoris yeast system emerged as the clear choice for the scale-up expression of Angiostatin(R) protein for human clinical trials. As a result of the molecular engineering of the Angiostatin(R) molecule, and the knowledge gained from biochemical studies performed by EntreMed scientists, we can now report that recombinant human Angiostatin(R) protein is being readily synthesized and purified at Covance." Dr. Kim Lee Sim, EntreMed's Vice President for Preclinical Research and Development, commented on Angiostatin(R) production: "EntreMed first reported on the generation of recombinant human Angiostatin(R) protein in Cancer Research in 1997. Since then, we have continued an active research and development program that has significantly refined our knowledge of this potent antiangiogenic molecule. Our efforts have greatly facilitated the successful engineering of the recombinant human Angiostatin(R) molecule with features that enable protein production at scales required for clinical testing." Dr. Sim continued, "EntreMed's research team has also placed a great deal of emphasis on the Angiostatin(R) protein receptor, and the potential for Angiostatin(R) as a gene-based delivery system. By the end of 1998, over 92 publications from around the world confirmed the antiangiogenic properties of this unique molecule; we anticipate that our internal research findings will contribute even further to the scientific literature." In 1995, EntreMed signed a Research, Collaboration and License Agreement with Bristol-Myers Squibb Company for Angiostatin(R) protein. As previously reported by EntreMed in February 1999, the agreement was then modified granting EntreMed development rights for Angiostatin(R) protein and rights with respect to future partnering and commercialization of the protein. 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. 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.