NCI Statement on Animal Studies of Endostatin and Angiostatin

The National Cancer Institute (NCI) is encouraged by results from animal (mouse) studies that suggest that compounds isolated by researchers in the laboratory of Judah Folkman, M.D., of Children's Hospital and Harvard Medical School in Boston, Mass., may be potent anti-cancer agents. NCI has made it a high priority to move research forward on these compounds, endostatin and angiostatin, so that clinical trials in humans can begin. It is important to note that such human studies will not begin for many months, most likely not until 1999. Once testing has begun, the compounds, which are anti-angiogenesis agents, must be tested separately for safety and efficacy in humans before they can be tested together.

Production of these compounds is one part of the process that must take place over the next several months. At this time, it is not possible to produce the large quantities of endostatin or angiostatin necessary for human trials. NCI is working with Entremed, Inc., on production issues for endostatin and with Bristol-Myers Squibb Co., on production issues for angiostatin.

It is very important to emphasize that while the possibilities raised by these studies in mice are encouraging, it is not known whether endostatin or angiostatin will be effective in people with cancer.

Clinical trials of other anti-angiogenesis agents are under way both by individual drug companies and by NCI. Patients interested in information about ongoing trials listed in NCI's PDQ database can contact the NCI's Cancer Information Service at 1-800-4-CANCER or PDQ themselves via the Internet (http://cancertrials.nci.nih.gov -- under "more" choose Introduction, then choose "finding specific trials.")