Patient Dies in Gene Therapy Experiment

The FDA has suspended a gene therapy study because of the death of a patient.

ByABC News
January 8, 2009, 12:23 AM

July 26, 2007 — -- The death of a patient enrolled in the clinical trial of an experimental gene therapy treatment has spurred the U.S. Food and Drug Administration (FDA) to halt the trial and begin safety reviews of 28 other gene therapy trials around the country.

According to an FDA press release issued Thursday, the Seattle-based Targeted Genetics Corporation, which conducted the trial, informed the FDA of the death on July 24.

The trial was designed to test the effectiveness of a new treatment for active inflammatory arthritis, which involves a vector -- a particle derived from a virus and used to deliver replacement genes into targeted cells.

Government regulators are still unclear as to what exactly caused the patient's death.

"Targeted Genetics notified FDA earlier that a patient in its trial experienced a serious adverse event," the FDA statement reads. "Even though the cause of the illness wasn't known, and is still uncertain, the agency immediately placed the trial on clinical hold -- meaning no further product can be administered and no new patients can be enrolled."

According to a statement issued by the company on Thursday, the other subjects who were already enrolled in the study will continue to be followed and monitored.