Nov. 6, 2001 Results from early clinical studies of a highly-publicized cancer drug designed to halt tumor growth by cutting off its blood supply indicates the medication is safe when combined with radiation therapy in the treatment of advanced cancers.
Daily doses of the drug Angiostatin, along with radiation, were given to 15 patients with advanced cancer, particularly cancers of the head and neck, prostate, breast and lung at the Kimmel Cancer Center at Thomas Jefferson University Hospital in Philadelphia. The patients didn't seem to suffer any ill effects from the treatment, other than what would normally be expected from receiving radiation, notes Adam Dicker, M.D., Ph.D., assistant professor of radiation oncology at Jefferson Medical College of Thomas Jefferson University, who led the trial along with Walter Curran, Jr., M.D., professor and chair of radiation oncology at Jefferson Medical College of Thomas Jefferson University and clinical director of Jefferson's Kimmel Cancer Center.
All patients had a partial response to the radiation and drug treatment, meaning their disease either temporarily stopped growing or regressed somewhat.
While researchers are encouraged by the initial results, they point out that the study, a Phase I clinical trial, typically tests for safety and to determine how the body handles the drug and is not necessarily aimed at measuring its effectiveness. Patients will continue to receive higher doses of Angiostatin in the coming parts of the trial.
Dr. Dicker presents his team's findings in Miami Beach October 31 at the international conference, Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications, sponsored by the American Association for Cancer Research, the National Cancer Institute and the European Organization for Research and Treatment of Cancer.
Patients received Angiostatin - an antiangiogenic drug candidate being developed by EntreMed, Inc., a Rockville, Md.-based biotechnology company - intravenously five times weekly prior to radiotherapy during a five-to-seven week period. Radiation doses were determined by the type and location of the patient's tumor. Some patients had chemotherapy prior to the study.
Dr. Dicker points out that the Angiostatin-radiation trial is one of two Phase I trials involving the drug conducted simultaneously at Thomas Jefferson University Hospital and Jefferson's Kimmel Cancer Center - the only trials of Angiostatin in the United States. The other trial found that giving Angiostatin alone to patients with advanced cancer who had failed prior chemotherapy was safe and had few side effects.
Carrying out two trials at once is a novel approach to acquire a significant amount of clinical data on a drug more quickly than usual, he notes.
Angiostatin is a protein and a natural tumor inhibitor discovered several years ago in mice in the laboratory of Harvard scientist and surgeon M. Judah Folkman, M.D. The drug works by blocking the formation of blood vessels, based on the theory that cancers cannot grow or spread without a blood supply to feed them - a process known as angiogenesis. Angiostatin is part of a class of drugs called angiogenesis inhibitors. Some researchers believe that Angiostatin and other anti-angiogenesis drugs will expand the armamentarium of drugs that will halt cancer growth, with the disease becoming more a chronic illness patients can live with.
Angiogenesis has become one of the hottest areas of cancer research.
EntreMed has been developing and testing anti-angiogenesis drugs in human clinical trials. Dozens of drugs are under development by companies all over the world.
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