Targeted Genetics Places Trial on Hold
This is classic, I waited several years to buy my shares
back (they are down about 65% in the past two years--buy
low, right?) and yet within 48 hours comes a PR for "adverse
event", sheesh. Well, that is bioteh for you, ha--here is
the bad news:
Targeted Genetics Places Trial on Hold
Wednesday July 25, 9:57 am ET
Targeted Genetics Places Arthritis Drug Study on Hold Over FDA, Safety Concerns; Shares Tumble
SEATTLE, Wash. (AP) -- Targeted Genetics Corp. has placed its development program for an inflammatory arthritis treatment on hold citing Food and Drug Administration and safety concerns.
The news sent the shares tumbling 55 cents, or 20.9 percent, to $2.08 in morning trading.
The drug candidate, tgAAC94, is in a Phase I/II clinical trial involving 127 patients that began October 2005. The goal of the early-to-midstage study is to test a range of parameters for safety, tolerability and effectiveness.
"As a precautionary measure, the FDA stopped further administration of tgAAC94 due to the uncertainty of the cause of a serious adverse event that occurred in one subject enrolled in the study," the company said in a statement Tuesday.
Those already enrolled in the study will continue to be monitored, the company said.
Targeted Genetics did not publicly disclose the nature of the "adverse event" but said it is working with its data safety monitoring board and the FDA to determine its cause.
The company also maintains that interim data reported over the past 12 months supports the safety and tolerability of the drug candidate.
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