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NIH panel okays human gene transfer test.

NIH Panel Okays Human Gene Transfer Test

A National Institutes of Health (NIH) advisory panel has given the go-ahead for a team of researchers to inject genetically engineered cells into humans. The experiment, which the panel said could be performed on no more than 10 terminally ill cancer patients, represents the first approval by a U.S. government agency for the use of gene-altered cells in humans.

Scientists say they expect the procedure will neither help nor harm the cancer patients -- who will be chosen from a pool of consenting individuals with life expectancies of less than three months -- but should provide valuable information that may lead to improvements in a promising new cancer therapy. More significantly, the experiments will provide the groundwork for other tests, not yet approved, in which scientists would insert therapeutically beneficial genes into patients' cells.

The tests must gain final approval from NIH Director James B. Wyngaarden and the Food and Drug Administration (FDA). But officials of both the NIH and the FDA have hinted strongly that such approval would be forthcoming if the protocol passed muster with the Recombinant DNA Advisory Committee (RAC), the NIH panel of scientists and ethicists that gave its approval this week. "We hope to be in patients by the first of the year," says W. French Anderson of the National Heart, Lung, and Blood Institute, who will perform the human studies with Steven A. Rosenberg and R. Michael Blaese, both of the National Cancer Institute.

The RAC's green light comes after months of discussion and controversy, in which experts wrestled with the scientific and ethical uncertainties inherent in the unprecedented application of genetic technology to human patients. In particular, the committee expressed concern about the safety of a genetically engineered retrovirus that will be used to insert a "marker" gene into a sample of the patients' white blood cells. The proposed experiments would be the first to expose humans intentionally to a retrovirus. The experiment will use only retroviruses not known to cause human disease and that have been stripped of their ability to reproduce.

The experiment builds upon ongoing research by Rosenberg and his colleagues at the National Cancer Institute. In those experiments, the researchers remove white blood cells from tumors in patients suffering from malignant melanoma, a deadly form of skin cancer. They grow the cells in culture with an immune-stimulating hormone called interleukin-2, then reinfuse billions of the beefed-up cells into the same patient from whom they were taken. Unpublished results given the NIH panel indicate about half the treated patients show significant improvement.

The new experiments are designed to provide information about why some patients respond to this treatment and others don't. Before reinfusing the cultured white cells into patients, the researchers will use a disabled retrovirus to "infect" some of the cells with a gene that will make the cells resistant to an antibiotic. These cells will be easy to find in subsequent blood and tissue samples, allowing researchers to map their "traffic patterns," survival time and biochemical characteristics in patients showing different clinical responses. If Anderson and his colleagues find that clinical improvement is, as they suspect, associated with white cells that produce specific biochemical factors, they hope to insert into future batches of cultured cells genes coding for increased production of those factors.

"Ten patients will be enough to demonstrate the safety of the procedure," says Rosenberg. "Very quickly I hope we'll be coming back to [the RAC] with a proposal to insert genes with therapeutic potential."
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Title Annotation:National Institutes of Health
Author:Weiss, Rick
Publication:Science News
Date:Oct 8, 1988
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