Targeted Genetics

Targeted Genetics reports tgAAC94 data

Fri, 30 May 2008 06:59:55 -0400

Targeted Genetics is reporting results from an early-stage study of tgAAC94 for inflammatory arthritis. The drug uses a specially engineered virus to transport a gene. When working properly, the therapy produces proteins that eliminate the inflammatory molecules that cause arthritis. The company said that while the trial was not powered to show statistical significance, "tgAAC94 has the potential to improve disease symptoms that are refractory to other therapies, including systemic TNF antagonists." According to CEO H. Stewart Parker, "these clinical observations will help guide further clinical development."

A clinical trial of tgAAC94 was placed on hold last year after the death of a study participant, which threw a spotlight on the safety record of the whole gene therapy field. However, the FDA determined tgAAC94 was not to blame and the study continued.

- here's Targeted Genetics' release

Editor's note: This article has been corrected. The previous version inaccurately reported that the trial had failed. However, the trial was not set up to determine efficacy.

Gene therapy trial to resume after patient's death

Mon, 26 Nov 2007 06:59:58 -0500

The gene therapy field is breathing a mighty sigh of relief after Targeted Genetics announced that it has received a green light to resume a clinical trial suspended after the death of a participant. The FDA made its decision after concluding that the gene-therapy study for rheumatoid arthritis did not contribute to the death of 36-year-old Jolee Mohr. A post mortem found that the experimental therapy did not spread in her body and did not greatly increase the immune suppression caused by another RA drug the patient was taking. Gene therapy has been seriously hampered in past years by unexpected trial deaths. Another safety fiasco now may well have put the research field back into slow motion.

- see the company's release
- read the report from the Seattle Times

Related Articles:
Biotech co. defends gene therapy trial standards. Report
Trial death spurs questions about gene therapy. Report
Targeted Genetics study on hold. Report
Targeted Genetics cuts staff. Report

SPOTLIGHT: Targeted Genetics hits back against trial report

Thu, 09 Aug 2007 06:59:53 -0400

Targeted Genetics went on the attack after The Washington Post raised serious criticisms of a gene therapy trial that was suspended after the death of a volunteer. But Wired also notes that the company's response avoids many of the most serious criticisms leveled in the report. Report

Trial death spurs questions about gene therapy

Fri, 27 Jul 2007 06:59:57 -0400

Earlier this week we reported that Targeted Genetics put its lead drug trial on hold after one of the subjects in the study became seriously ill. Now the patient in question has died and FDA is investigating the death to see if the gene therapy trial--and others like it--poses serious risks to patients.

Targeted Genetics was conducting Phase I trials of tgAAC94, a potential treatment for inflammatory arthritis that is injected directly into the joints. The patient suffered undisclosed symptoms after receiving a second injection of tgAAC94, though it is as yet unknown whether the illness was a result of the therapy or a coincidence. Gene therapy works by replacing the faulty genes that cause disease with healthy ones. Many researchers believe the therapy holds great promise for treating otherwise incurable diseases such as HIV, Parkinson's, cancer and numerous immune disorders.

- read the FDA's statement on the death
- see the release from Targeted Genetics
- read the New York Times report for more

Related Articles:
Gene therapy makes a big comeback. Report
New advances made in gene therapy for HIV. Report
First gene therapy for eye disease may offer a cure. Report
Gene therapy cures two of advanced melanoma. Report
Targeted Genetics cuts staff. Report