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FDA Statement on Gene Therapy Clinical Trial

Posted on: 26 July 2007, source: FDA
On July 24, 2007 the U.S. Food and Drug Administration (FDA) was informed by Targeted Genetics Corporation of Seattle about the death of a patient who received an investigational gene therapy product in a clinical trial for the treatment of active inflammatory arthritis. FDA's condolences go to the patient's family. FDA is providing this preliminary information in recognition of the public's interest in these types of new therapies. Targeted Genetics notified FDA earlier that a patient in its trial experienced a serious adverse event. 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. The product that was being studied uses a particle called a vector that is designed to deliver treatment genes to target cells.