University halts Vical studies
Documents released today at the Recombinant DNA Advisory Committee meeting in Washington revealed that the Institutional Biosafety Committee (IBC) at the University of South Florida has halted its trials of Vical's Allovectin-7 gene therapy for cancer. The decision to halt the study in Florida followed a patient death at a different site that had been blamed on "disease progression and unrelated to Allovectin-7" but was later reclassified by investigators as "probably related to the study therapy." Studies at about 50 other centers are continuing.
VICL spokesperson Alan Engbring said enrollment was halted only at the Florida site on Feb. 23, and that no patients were being treated with Allovectin-7 at the time. The company has provided details of the death requested by the IBC and will provide additional safety data related to Allovectin-7, he said. ...