FDA Suspends Gene Therapy Studies 
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 FDA Suspends Gene Therapy Studies

FDA Suspends Gene Therapy Studies

.c The Associated Press

 WASHINGTON (AP) - The government has ordered Schering-Plough Corp.
to temporarily halt two gene therapy studies because the research is designed
similarly to a Pennsylvania experiment in which a {*filter*}-ager died last month.

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 cooking.net">food and Drug Administration decision late Friday 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.

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.

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.

AP-NY-10-11-99 1511EDT

 Copyright 1999 The Associated Press.  The information  
contained in the AP news report may not be published,  
broadcast, rewritten or otherwise distributed without  
prior written authority of The Associated Press.

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Fri, 29 Mar 2002 03:00:00 GMT
 
 [ 1 post ] 

 Relevant Pages 

1. U.S. SUSPENDS GENE THERAPY STUDIES, TEENAGER KILLED

2. FDA Stops Researcher's Human Gene Therapy Experiments

3. FDA: Gene Therapy Rules Violated

4. FDA: Gene Therapy Rules Violated

5. GENE THERAPY STUDY FOR PARKINSON'S DISEASE

6. Gene therapy Parkinson's disease in pre-clinical studies

7. Study if Gene Therapy Plus Surgery is Effective

8. QUESTIONS: Gene Therapy in Neurosurgery: the thymidine kinase suicide gene

9. Cancer and Gene therapy ( T gene)

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