Nov. 13, 2000 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 data," said Kufe. "The study was designed to measure Endostatin's safety, not its efficacy. We were pleased to see no major side effects at all dose levels, but further research is needed to determine which dose and infusion schedule are most appropriate for this therapy."
The Boston data being presented comes primarily from the first five groups of patients infused in 28-day cycles in what is known as a "dose escalation" trial. Groups of three patients each were enrolled and infused at 15, 30, 60, 120, and 240mg/m2 (milligrams per meter squared-a ratio of drug to body mass) dose levels.
Additional patients are being treated at either 60 or 240mg/m2 dose levels to obtain further clinical data on Endostatin. These patients will be given Endostatin daily for two months and then moved to a continuous infusion regimen.
"Continuous infusion of Endostatin provides us with the ability to maintain constant levels of the drug in patients rather than the 'peaks and troughs' observed with the current regimen," said Kufe. "We will look for any differences resulting from this approach."
Boston hospitals are currently selecting the final patients into the Phase I trial from their original patient database that opened in fall 1999 and closed to new patient enrollment in July 2000. Patients who enrolled in this database will be contacted if they have been selected for the final slots in the trial. No information is available at this time about future Endostatin clinical trials at Boston hospitals.
Data from the ongoing study at Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital, and Beth Israel Deaconess Medical Center and the other two sites will be used to determine appropriate treatment regimens and doses for future studies.
Information regarding other clinical trials can be found on the web sites for Dana-Farber, Mass. General, Brigham & Women and Beth Israel Deaconess.
The Phase I study is being conducted by Dana-Farber/Partners CancerCare -- a collaboration of Dana-Farber Cancer Institute, Brigham and Women's Hospital and Massachusetts General Hospital -- in conjunction with Beth Israel Deaconess Medical Center, a member of the CareGroup healthcare system. The sponsor for this trial is EntreMed, Inc., Rockville, Maryland.
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