Targeted 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
targetedgenetics.
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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