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Cancer Drug Trial Green-Lighted

The researcher who discovered two drugs that have eliminated cancer tumors in mice said he has received federal permission to treat about 30 terminally ill patients who have not responded to other drugs.

In a Friday interview with the Chicago Tribune, Dr. Judah Folkman of Harvard University and Boston Children's Hospital, said he has received permission to treat the patients on a "compassionate basis," a protocol reserved for desperately ill patients under which federal requirements for pre-clinical testing are waived.

The drugs, angiostatin and endostatin, are highly experimental and have been tried only in mice, where they have caused cancerous tumors to permanently disappear. The first, very limited tests of the drugs on humans could come by the end of the year or early next year, Folkman said.

Folkman told the Tribune that angiostatin and endostatin are being produced by a National Cancer Institute facility, not in mass quantities, "but just enough for a small number of patients."

"So far, they're right on schedule for December or the first of the year. That's our hope," he said.

It will still be 12 to 18 months before the company licensed to develop the drugs will have enough to begin full-scale clinical human trials.

Additionally, Folkman is saying the new class of cancer drugs may also work against leukemia on mice.

Folkman said in a telephone interview Sunday with Reuters he was surprised to find they worked against leukemia in mice.

One of the drugs, endostatin, seems to put leukemia in remission when used alone.

And Folkman said he had found a third natural protein, called vasculostatin, to add to the growing arsenal of angiogenesis inhibitors.

The angiogenesis inhibitors stop the formation of blood vessels that feed a tumor. The compounds, and there are more than a dozen in development, literally starve out a tumor.

The hope is that they will be less toxic than current cancer therapy, which involves surgery and either strong chemicals or radiation that kill both the cancer cells and many healthy cells.

"They remained without symptoms," Folkman said. "We don't know if they are cured. We don't use the word cure."