>>Targeted Genetics Subject Dies in Trial
Thursday July 26, 5:39 pm ET
Targeted Genetics Says Patient Dies in Clinical Trial Now on Hold Over Safety Concerns
NEW YORK (AP) -- Targeted Genetics Corp. said Thursday a patient died in its early-to-midstage study of a potential inflammatory arthritis drug.
On Tuesday, the company said the development program for the drug candidate, tgAAC94, was placed on hold after a patient suffered a serious adverse event. That person has died.
Targeted Genetics still has not disclosed the nature of the event. It said the "clinical course" the patient experienced has never been seen as a consequence of exposure to the type of compound.
"We are deeply saddened by the death of an individual enrolled in our clinical trial. The welfare of the trial participants is always our foremost consideration and concern," said H. Stewart Parker, president and chief executive of Targeted Genetics.
The study, a Phase I/II clinical trial involving 127 patients that began October 2005, is aimed at testing a range of parameters for safety, tolerability and effectiveness. Those already enrolled in the study will continue to be monitored, the company said.
The company is working with its data safety monitoring board and the Food and Drug Administration to determine what led to the death.
Shares of Targeted Genetics fell 5 cents to $2.02 in after-hours trading after falling 3 cents to close at $2.07<<
Oh, dear. Expect to see all gene therapy stocks get whacked now. They might recover if the patient was in the control arm, but that seems unlikely. Jesse Eisinger revisited.
Cheers, Tuck |
