Boston hospitals report early results of endostatin clinical trial

Information from phase I trial reported today in Amsterdam

BOSTON--Clinical researchers at Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital and Beth Israel Deaconess Medical Center today presented preliminary information from their Phase I clinical trial of Endostatin™ Protein, an angiogenesis inhibitor that seeks to reduce tumors by cutting off their blood supply.

Early results from 19 patients treated in the Boston clinical trial were reported in Amsterdam at the Symposium on New Drugs in Cancer Therapy sponsored by the National Cancer Institute, European Organization for Research and the Treatment of Cancer and American Association of Cancer Research. Results from patients treated in Texas and Wisconsin were also reported at the conference being held November 7 - 10.

"Endostatin is safe and well-tolerated in high doses without any evidence of toxicity," said Donald Kufe, MD, principal investigator of the Harvard hospital clinical trial. "Extended periods of stable disease and minor responses have been demonstrated; however, these are early results and further study is needed to determine just how effective this therapy will be over time."

The Boston hospitals were the first to begin testing of the Endostatin Protein in patients in fall 1999. Since then, 19 patients have been enrolled in the Boston portion of this Phase I trial. Two patients in Boston are currently receiving treatment and twelve patients were taken off the study due to disease progression. The remaining patients voluntarily withdrew from the study.

Of the patients being reported on in Europe, four were diagnosed with breast cancer, three with lung cancer, three with colon cancer, two with pancreatic cancer, two with neuro-endocrine tumors, two with sarcoma, and three with other forms of cancer.

"It is too early to assess the clinical significance of Endostatin's effectiveness based on this preliminary

Contact: Todd Ringler
Dana-Farber Cancer Institute

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