Targeted Genetics Announces Positive Phase 1/2 TgAAC94 Data Presented At Annual European Congress Of Rheumatology
13 Jun 2008Targeted Genetics Corporation (Nasdaq: TGEN) announced 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.
Study Details
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.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This release contains forward-looking statements regarding the Company's business strategy and product development, including statements regarding the data collected in the inflammatory arthritis study, the potential efficacy of tgAAC94, the potential impact of the study on our results of operations and other statements about the Company's plans, objectives, intentions and expectations. These statements involve current expectations, forecasts of future events and other statements that are not historical facts. Inaccurate assumptions and known and unknown risks and uncertainties can affect the accuracy of forward-looking statements. Factors that could affect actual future events or results include, but are not limited to, payments anticipated by the Company under product development collaborations and contracts, the Company's actual expenses, the Company's ability to raise capital when needed, the timing, nature and results of the Company's clinical trials, potential development of alternative technologies or more effective products by competitors, the Company's ability to obtain and maintain regulatory or institutional approvals, the Company's ability to maintain its listing on the NASDAQ Capital Market and the Company's ability to obtain, maintain and protect its intellectual property, as well as other risk factors described in its filings with the Securities and Exchange Commission (SEC), including in "Item 1A. Risk Factors" in the Company's most recent quarterly report on Form 10-Q for the quarter ended March 31, 2008 filed with the SEC. You should not rely unduly on these forward-looking statements, which apply only as of the date of this release. The Company undertakes no duty to publicly announce or report revisions to these statements as new information becomes available that may change the Company's expectations.
Targeted Genetics Corporation
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