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Biotech / Medical : Gene therapy

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To: mike head who wrote (172)10/14/1999 4:37:00 AM
From: Cheryl Galt  Read Replies (1) of 319
 
More fallout from the misfortune at U Penn:

AP - Oct 11 - msnbc.com
FDA suspends 2 gene therapy studies
Research similar to experiment linked to a teen's death

-- 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 teen-ager died last month. ....

The 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. ....

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.
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Another report on the same story:

Reuters - Oct 12 - medscape.com
FDA Halts Enrollment in Gene Therapy Study
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