Targeted Genetics Announces Positive Phase 1/2 tgAAC94 Data Presented at Annual European Congress of Rheumatology
- Category: DNA RNA and Cells
- Published on Thursday, 12 June 2008 02:00
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Targeted Genetics Corporation announced today that positive results of a Phase 1/2 clinical study demonstrate that tgAAC94, its investigational agent designed to inhibit activity of tumor necrosis factor-alpha (TNF-alpha), a key mediator of inflammation, is well tolerated and may improve disease symptoms in inflammatory arthritis patients refractory to other therapies, including systemic TNF antagonists
SEATTLE, WA, USA and PARIS, FRANCE | June 12, 2008 | Targeted Genetics Corporation (Nasdaq: TGEN) announced today that positive results of a Phase 1/2 clinical study demonstrate that tgAAC94, its investigational agent designed to inhibit activity of tumor necrosis factor-alpha (TNF-alpha), a key mediator of inflammation, is well tolerated and may improve disease symptoms in inflammatory arthritis patients refractory to other therapies, including systemic TNF antagonists. Full results of the study were presented here today during an oral presentation at the Annual European Congress of Rheumatology (EULAR).
The Phase 1/2 study evaluated multiple doses of tgAAC94 administered directly to affected joints with or without concurrent systemic TNF antagonist therapies. The study achieved its primary endpoint of safety and tolerability.
"We are encouraged by the patient-reported symptom improvement -- early signs of efficacy that indicate further study is warranted," said Philip Mease, M.D., Chief, Rheumatology Clinical Research Division of Swedish Hospital Medical Center and Head of Seattle Rheumatology Associates, who presented the data.
127 patients with inflammatory arthritis received a single intra-articular injection of either tgAAC94 or placebo, followed by a second injection 12-30 weeks later depending on when the injected joint met criteria for re-injection. tgAAC94 was well tolerated at all dose levels. Two SAEs of focused interest were reported -- a culture-negative septic arthritis considered probably related to study drug and a fatal disseminated histoplasmosis and retroperitoneal hemorrhage considered not related to study agent. Administration site reactions were observed in 12% of subjects.
Preliminary signs of efficacy were also observed in the study, most notably a 30% decrease in patient-reported pain and functional scores as measured by the global visual analog scale (VAS) in the tgAAC94-treated arm versus the placebo arm. Global VAS is a clinically meaningful and commonly used assessment tool to help patients describe the intensity of their pain and functional capacity.
About Targeted Genetics Corporation
Targeted Genetics Corporation is a biotechnology company committed to the development of innovative targeted molecular therapies for the prevention and treatment of acquired and inherited diseases with significant unmet medical need. Targeted Genetics' proprietary Adeno-Associated Virus (AAV) technology platform allows it to deliver genes that encode proteins to increase gene function or RNAi to decrease or silence gene function. Targeted Genetics' product development efforts target inflammatory arthritis, AIDS prophylaxis, congestive heart failure and Huntington's disease. To learn more about Targeted Genetics, visit Targeted Genetics' website at http://www.targetedgenetics.com.
SOURCE Targeted Genetics Corporation