Additional human gene transfers sought.

Additional humen gene transfers sought

Presenting evidence that the first U.S.-approved infusions of gene-altered cells into humans have triggered no ill effects in the six cancer patients treated so far, federal researchers this week asked an advisory panel to speed permission for expanded use of the experimental procedure. But the specter of biotech gadfly Jeremy Rifkin stalled approval of the request, forcing the researchers to delay expanded testing until at least April.

Several members of the Recombinant DNA Advisory Committee, which advises the National Institutes of Health on experiments involving genetic engineering, expressed support for the request. But committee members balked at an immediate okay, noting that Rifkin (president of the Washington, D.C.-based Foundation of Economic Trends) had sued NIH the last time they tried to expedite the approval process. Instead, they agreed to meet on March 30 -- three months ahead of schedule -- in a joint sessions with the NIH subcommittee that shares responsibility for such decisions, in hopes of resolving the issue then.

The experiments, led by NIH researchers W. French Anderson, Steven A. Rosenberg and R. Michael Blaese, are designed to track the movements and activities of genetically labeled cancer-fighting lymphocytes used in an experimental treatment in melanoma patients (SN: 5/27/89, p.324). The researchers say they will soon infuse four more patients, in keeping with a 1989 protocol granting them permission to administer thelabeled cells to 10 terminally ill patients. But they express frustration that NIH guidelines might require them to wait six months or more to gain approval for additional trials, halting the experiments just when data have begun to accumulate.

Rosenberg reports that the engineered cells survive three weeks to two months in circulating blood and more than seven weeks in some tumors. In one patient, the researchers removed some of the gene-altered cells that had homed in on a tumor, then expanded this population in the laboratory and reinjected the cells into the patient. That patient, like several others in the study, has shown "dramatic" improvement, Rosenberg says. However, he adds, the researchers cannot perform the biological and statistical analyses required to understand and enhance those effects unless more patients receive the treatment.