CBSN

Gene Therapy Studies Halted

The government has ordered Schering-Plough Corp. to suspend two gene therapy experiments because their research is designed similarly to a Pennsylvania experiment in which a teen-ager died last month, reports CBS News Correspondent Christopher Glenn.

No one yet knows what killed Jesse Gelsinger, 18, of Tucson, Ariz. Just four days before his death, University of Pennsylvania scientists had placed healthy genes in his liver to combat a rare metabolic disease.

Penn's study has been halted while scientists there, along with federal regulators, try to determine what went wrong.

The Food and Drug Administration decision halts two separate experiments by Schering-Plough to try gene therapy as a treatment for liver cancer and for colorectal cancer that spreads to the liver.

Those studies have one similarity to the Penn experiment that worried regulators: They use relatively high doses of a type of cold virus called adenovirus to slip new genes directly into the liver.

The FDA decision does not affect dozens of other gene therapy experiments that use lower doses of adenoviruses or that inject them into some organ other than the liver.

"They are not halting all gene therapy trials. There are many trials underway that are quite different from the one going on at the University of Pennsylvania and those will continue to go on," said CBS News Medical Correspondent Dr. Emily Senay.

No deaths or unexpected side effects have been seen in the Schering trials, but the studies' suspension is a precaution to let the FDA scrutinize patient data for any early signs of problems, FDA gene therapy chief Dr. Philip Noguchi said Monday.

The FDA wants to see "if there's any pattern we might be able to understand, to give us some insight into the Penn study," he said.

The FDA suspension means Schering cannot enroll any new patients, but patients already given their first gene dose can receive the rest of their scheduled treatment, said company spokesman Robert Consalvo.