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
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 http://www.entremed.com.