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| |  AACR-EORTC-NCI: Endostatin, Angiostatin Well Tolerated by Cancer Patients By Ed Susman Special to DG News MIAMI BEACH, FL -- October 31, 2001 -- New studies on the anti-angiogenesis agents angiostatin and endostatin reveal that the drugs appear to have little toxicity and can be tolerated long-term by patients, researchers say. In reports to the international conference on "Molecular Targets and Cancer Therapeutic: Discovery, Biology and Clinical Applications", the 12th annual joint meeting of the American Association for Cancer Research, the European Organization for Research and Treatment of Cancer and the National Cancer Institute of the United States, researchers said that angiostatin could be taken for as long as 11 months. The drugs would be self-administered much the way diabetic patients give themselves insulin shots. Emile Voest, MD, professor of medical oncology at the University Medical Center Utrecht, the Netherlands, said, "As a clinician, I want to continue treating patients and preserve quality of life by allowing patients to manage their cancer at home with a self-administered shot." Twenty-four patients participated in the study, 10 men and 14 women. They had cancer of either the lung, colon or ovary. The subjects injected themselves twice a day with angiostatin at doses of 7.5 mg, 15 mg and 30 mg, calculated for body surface area. Initially, the patients injected themselves daily for 28 days and were then observed for a week. After that, they continued the injections without interruption. While about half the subjects reported injection site irritation, Dr. Voest said there were no cumulative or other major toxicities in the study. "These data are encouraging for science and patients," said Edward Gubish, president of EntreMed, Inc., Rockville, Maryland, United States, which funded the studies on angiostatin and endostatin. In the endostatin trial, H.M. "Bob" Pinedo, MD, professor of medical oncology and chief of the department of medical oncology at the Free University Medical Center, Amsterdam, the Netherlands, reported that patients could tolerate endostatin if it were delivered by an continuous infusion pump of through self-administered injections. "Endostatin was safe and well-tolerated in all treatment schedules with predictable pharmacokinetics," Dr. Pinedo said. In this study, 20 advanced cancer patients who were resistant to prior chemotherapy and/or radiation therapy received endostatin through continuous intravenous pumps for four weeks, followed by twice daily subcutaneous injections of endostatin at three doses, 3.75 mg, 7.5 mg, and 15 mg, based on the person's body surface area. "Some patients were able to stay on the drug for as long as 200 days," Dr. Pinedo said. Future studies will continue the dose escalation up to a proposed 240 mg a day. Dr. Pinedo said that the maximum tolerated dose of endostatin has yet to be achieved. he said no drug-related toxicities were observed and no antibodies against endostatin were detected.
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