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Back To Vidyya New Approach To Cancer Chemotherapy Starts Tenth Phase I Clinical Trial

EntreMed Has Initiated A Phase I Clinical Trial Of Angiostatin

EntreMed, Inc. today announced commencement of its tenth clinical trial of an angiogenesis inhibitor in just over one year. EntreMed has initiated a Phase I clinical trial of Angiostatin, a potent, naturally occurring inhibitor of angiogenesis, administered by subcutaneous, or beneath the skin, injection. The Company recently signed a clinical study agreement with the University Medical Center at Utrecht, The Netherlands, to conduct the study. To date, four cancer patients with progressive disease have already received Angiostatin through twice daily subcutaneous injections to assess the safety of this route of injection. Patients will treat themselves with Angiostatin at home.

A similar study is underway in Amsterdam testing two routes of administration for Endostatin, a second antiangiogenic product candidate under development by EntreMed. The Amsterdam study is comparing administration of Endostatin by subcutaneous injection and a lightweight pump that introduces a continuous supply of the drug into a patient's body. Both studies are designed to gather data necessary to push these drugs to the next level of development, bringing them one step closer to EntreMed's goal of rapid commercialization.

Professor Doctor Emile E. Voest, in the Department of Medical Oncology, at University Medical Center Utrecht in The Netherlands, will serve as principal investigator for the new Angiostatin trial which is a Phase I, single-center, open-label, dose escalation, safety and pharmacokinetic study in cancer patients. The study is expected to include a total of 24 patients divided as three groups of eight patients per group.

Dr. Voest, commented, "Patients are very enthusiastic to participate in this study because it is a different approach to treat cancer than chemotherapy. This study will shed light on the optimal dosing of Angiostatin and is designed to facilitate long term treatment by teaching patients to inject themselves with Angiostatin at home."

Dr. Edward R. Gubish, Jr., EntreMed's Executive Vice President for Research and Development, commented: "In October 1999, EntreMed announced the initiation of its first clinical trial for Endostatin protein. By April of this year, we had added clinical trials for Angiostatin protein and 2ME2, putting all three of our lead product candidates into the clinic. Now, In December 2000, we have a total of ten clinical trials underway in the United States and Europe. This is representative of the tremendous strides being made by EntreMed's team in accelerating the clinical development of these antiangiogenic agents in cancer patients around the world."

Angiostatin was the first naturally derived antiangiogenic protein discovered under EntreMed funding in 1994 by Drs. Michael O'Reilly and Judah Folkman at Children's Hospital Boston. Angiostatin is currently being tested by EntreMed in two studies underway in the United States at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania. The first study evaluates the safety of intravenous Angiostatin as a single agent when administered intravenously to cancer patients, and the second evaluates the safety of Angiostatin when used in combination with radiation therapy.

The new Angiostatin study is open only to patients living in close proximity to Utrecht University. For further information on Angiostatin protein and the other clinical trials of angiogenesis inhibitors currently being conducted by EntreMed, see

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Editor: Susan K. Boyer, RN
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