Targeted Genetics Announces Positive Phase 1/2 tgAAC94 Data Presented at Annual European Congress of Rheumatology
12 6월 2008 - 2:00PM
PR Newswire (US)
SEATTLE and PARIS, June 12 /PRNewswire-FirstCall/ -- 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. 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. DATASOURCE:
Targeted Genetics Corporation CONTACT: European Media, Carolyn
Wang, +1-415-225-5050, , or U.S. Media, Stacie D. Byars,
+1-206-660-2588, , both of WeissComm Partners, for Targeted
Genetics Corporation Web site: http://www.targetedgenetics.com/
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