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

To: StockDoc who wrote (1926)	5/17/1999 10:46:00 AM
From: Don Dorsey	Read Replies (2) \| Respond to of 2135

EntreMed, Inc. Announces Phase I Human Clinical Trial Sites for Recombinant Human Endostatin Protein Health/Medical Writers ROCKVILLE, Md.--(BW HealthWire)--May 17, 1999-- Sites Named at 35th Annual Meeting of American Society of Clinical Oncologists EntreMed, Inc. (NASDAQ:ENMD) today announced the three medical centers that will become the first sites for Phase I human clinical trials of recombinant human Endostatin(TM) protein in cancer patients. The announcement was made at the 35th annual meeting of the American Society of Clinical Oncology, in Atlanta. 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. "I look forward to working with Dr. Folkman's lab and his exceptional team at Children's Hospital when the clinical trial begins this Fall," said principal investigator Donald W. Kufe, MD based at Dana-Farber. "We have the unique opportunity to initiate the first human safety trial with this novel new protein." Dr. Folkman will be part of the scientific team selected to evaluate Phase I clinical trial data. The additional Phase I clinical trial sites are the University of Texas M.D. Anderson Medical Center in Houston, and the University of Wisconsin Comprehensive Cancer Center in Madison. These centers were selected by the National Cancer Institute and will commence their Phase I clinical trials under an NCI-sponsored Investigational New Drug (IND) application to the Unites States Food and Drug Administration. The Dana-Farber/Partners CancerCare study will be conducted under an EntreMed-sponsored IND. Dr. John W. Holaday, EntreMed Chairman, President and Chief Executive Officer commented: "EntreMed is proud to take Endostatin(TM) protein into human clinical trials just three years after its discovery by Drs. O'Reilly and Folkman, and only two years after its first publication in the scientific journal, Nature. " Endostatin(TM) protein is EntreMed's lead product candidate. In numerous preclinical studies, Endostatin(TM) protein inhibited the growth of primary and metastatic tumors with no drug resistance or toxicity demonstrated. EntreMed has been engaged in the GMP-production of clinical grade Endostatin(TM) protein through its contract manufacturer, Covance Biotechnology Services, Inc., since November 1998. Phase I clinical trials of investigational new drugs are designed to evaluate the safety profile and to measure levels of the drug in order to help define an appropriate therapeutic dose for further studies. This is generally done through several trial sites involving small groups of people. Phase I trials are not designed to test the effectiveness of a drug. In these studies, EntreMed is seeking to ascertain whether or not this naturally-occurring protein shows a similar lack of toxicity and safety profile in human clinical testing as was repeatedly demonstrated in the Company's preclinical testing in mice and primates. EntreMed also owns exclusive worldwide rights to over 250 US and foreign pending and issued patents relating to its core technologies and product candidates, including Angiostatin(R) protein and 2-methoxyestradiol. 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.