Gene therapy trial to resume after patient death

FDA says Targeted Genetics can again test arthritis drug

updated 7:38 a.m. ET Nov. 26, 2007

WASHINGTON - Drug developer Targeted Genetics Corp. said Monday it will resume the study of an experimental arthritis drug that was halted in July after the unexpected death of a patient.

The Food and Drug Administration gave the Seattle-based company permission to continue the trial after reviewing information on all 127 patients, including a 36-year-old woman who died a few weeks after receiving the drug.

The woman’s family and government scientists have questioned whether a genetically modified virus used when the drug is injected played a role in her death. However, government advisers for the National Institutes of Health said earlier this year that the woman probably died of an unrelated fungal infection.

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The company’s own investigation reached a similar conclusion earlier this month, noting that only trace amounts of the virus were found in the woman’s body. The injected virus is meant to deliver a new gene that helps ease arthritis pain.

Jolee Mohr of Taylorsville, Ill., was also taking antiviral and antibiotic medicines, which government experts said could have weakened her body’s ability to fend off infection.

The National Institutes of Health’s advisers are scheduled to meet in December to complete their inquiry, though panelists have said it may not be possible to unequivocally identify Mohr’s cause of death.

While NIH’s advisers make recommendations on how to conduct clinical trials, companies do not need their permission to start or resume studies.

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