To: Anthony@Pacific who wrote (10864 ) 2/12/1999 9:15:00 AM From: Doorman Read Replies (1) | Respond to of 122088
Anthony here's today's NY Times article - pretty balanced. Note the second to last paragraph that says the results that had the stock fly to 85 due to the NY Times article last May, were achieved when BOTH proteins were combined...LOL Scientists Say They Confirm Tests on Cancer Drugs By DENISE GRADY cientists at the National Cancer Institute say they have finally duplicated some of the extraordinary experiments performed by Dr. Judah Folkman, who reported in 1997 that his research team at Harvard had destroyed cancerous tumors in mice by giving the animals drugs that cut off the tumors' blood supply. The confirmation of Dr. Folkman's results, first reported Thursday by The Boston Globe, is a turnabout by the institute and comes less than three months after scientists there said publicly that they could not reproduce Dr. Folkman's work. His research had generated intense interest among other scientists, and hope among the public as well, particularly after it was described in a front-page article in The New York Times in May. But the complaints that government scientists could not match Dr. Folkman's discoveries cast doubt on the findings; it is a basic rule of science that no experiment is trusted unless it can be reproduced by other researchers. Now, reassured by its recent successes, the institute has begun planning the first tests in people of one of the drugs developed by Dr. Folkman and his colleagues, endostatin. This week the institute invited medical centers to design experiments to test the drug in cancer patients. The studies are expected to begin late this year. But officials at the institute emphasized today that the studies would include only a small number of patients and would be the most basic type of study done in people, known as a Phase I trial. Such studies are designed primarily to test whether a drug is safe for people, not whether it is effective. Dr. James M. Pluda, a senior clinical investigator at the cancer institute, said the studies would accept only people with solid tumors, meaning cancers of the colon, breast and other organs. Patients with leukemia and other cancers affecting the blood will be excluded. He also cautioned, as Dr. Folkman and others have, that successful tests in mice are no guarantee that drugs will work in people. "Lots of drugs have had great activity in mice and then have not worked in people," Dr. Pluda said. "It's very premature to extrapolate from mouse data that this drug will have the same activity in people that the mouse version had in mice in Folkman's lab. We need careful clinical trials to evaluate whether this drug will have any activity at all." When government researchers first tried to reproduce Dr. Folkman's results, they found that mouse endostatin slowed the growth of tumors only slightly. So the cancer institute and Dr. Folkman agreed that institute scientists should visit his laboratory at Children's Hospital in Boston and learn his techniques for dealing with the substances, which are extremely difficult to manufacture, transport, store and handle. The other substance developed by Dr. Folkman and his colleagues is called angiostatin. Both endostatin and angiostatin work against tumor blood vessels. Children's Hospital has made agreements with Entremed, a small biotechnology company in Maryland, to work with both. In turn, Entremed made an agreement with the Bristol-Myers Squibb Company to develop angiostatin, but on Tuesday Bristol-Myers announced it was suspending the deal because of its concerns over whether it would be possible to make enough angiostatin to test it in people. Entremed's stock price, which tumbled on that news, regained the lost ground yesterday, after the cancer institute's action was reported. Mary Sundeen, a spokeswoman for Entremed, said it had contracted with Covance Biotechnology Services Inc. of Research Triangle Park, N.C., to produce large quantities of the drug. Ms. Sundeen said it would make two pounds of endostatin, more than enough for a Phase I study, in time for the trials to begin. Ms. Sundeen also said Entremed expected to be able to manufacture angiostatin as well, and hoped to be ready before the end of this year to seek approval for testing it in humans. A spokesman for Bristol-Myers Squibb said the company might resume its involvement with angiostatin if Entremed could develop a reliable manufacturing process and make a form of angiostatin that proved safe and effective. Angiostatin is more difficult to make than endostatin. So far, it seems that endostatin is the more powerful drug against tumors. But the best results in the tests on mice were achieved when the drugs were combined. For cancer institute scientists, the next step will be to do the same experiments at the Bethesda, Md., laboratories, with endostatin made in Boston by Dr. Folkman's team and with a version made at government laboratories.