CliniGene - NoE

AAV SAE on a Inflammatory arthritis trial - July 2007

A patient enrolled in a gene therapy trial using AAV expressing a soluble TNFR-Fc in severe arthritis has died in July 2007. Please find below links to statement and press releases on this issue. The patient died just after the second injection was given. The precise cause of the death has not yet been identified; investigation is underway.

Scientific papers

Official positions from European and US-scientific committes acting as advisory bodies to competent authorities

Report on NIH RAC meeting September 17, 2007

Discussion of a Serious Adverse Event on a Human Gene Transfer Trial - Using an Adeno-Associated Viral Vector: Analysis of Its Scientific and Safety Implications

Martina Schuessler-Lenz and Klaus. Cichutek, Div. Medical Biotechnology, Paul-Ehrlich-Institut, Langen, Germany

Information and Reports from European and US-scientific societies

FDA Statement on Gene Therapy Clinical Trial

Information and Reports from Others

Targeted genetics press relesase

Targeted genetics provides update on inflammatory arthritis phas I/II trial

From CNN website:

Gene therapy patient dies, trial shut down

From the Washington Post

Death Points to Risks in Research