Interim Data on Use of tgAAC94 in the Treatment of Inflammatory Arthritis Presented at the European Rheumatology Meeting; Resul
22 6월 2006 - 8:30PM
Business Wire
Targeted Genetics Corporation (Nasdaq:TGEN) announced today that
the principal investigator for its current clinical studies, Philip
Mease, M.D., Chief, Rheumatology Clinical Research Division of
Swedish Hospital Medical Center and Head of Seattle Rheumatology
Associates, presented data from a completed Phase I and ongoing
Phase I/II trial of tgAAC94 in patients with inflammatory
arthritis. tgAAC94 is an investigational therapeutic designed to
inhibit the activity of tumor necrosis factor-alpha (TNF-alpha), a
key mediator of inflammation. The data support the safety and
tolerability of intra-articular administration of tgAAC94 to
affected joints and suggest that tgAAC94 may lead to improvements
in signs and symptoms of arthritis in injected joints. Importantly,
these improvements have been observed in patients with and without
concurrent systemic TNF-alpha antagonist therapies. Dr. Mease
presented this data at the Annual European Congress of
Rheumatology, taking place in Amsterdam June 21st-24th. tgAAC94
utilizes an adeno-associated virus (AAV) vector to deliver the gene
encoding a soluble form of the receptor for TNF-alpha (TNFR:Fc)
directly to affected joints. TNFR:Fc protein is a potent inhibitor
of TNF-alpha. "Although the number of patients evaluated thus far
is relatively small, these data are very encouraging and suggest
positive response trends," said Dr. Mease. "Many patients with
inflammatory arthritis fail to achieve sufficient disease control
in one or more joints and continue to experience pain and
discomfort. tgAAC94 is a promising investigational therapeutic that
may provide clinical benefit to these patients and allow them to
manage their disease more effectively. The safety and responses
observed in clinical trials to date suggest that tgAAC94 has the
potential to advance the care of patients with inflammatory
arthritis." In the completed Phase I study, 12 females and 2 males
with rheumatoid arthritis and 1 male with ankylosing spondylitis
received an injection into the knee (n=14) or ankle (n=1) and were
followed for 24 weeks. Improvement in a composite tenderness and
swelling score was noted in all treatment groups, particularly
among subjects who received the higher dose of tgAAC94.
Intra-articular administration of tgAAC94 was safe and well
tolerated. None of the reported adverse events were definitely
related to the study drug. In the ongoing Phase I/II study,
approximately 120 adults are being randomized into three dose
groups to receive a single intra-articular injection of either
tgAAC94 or placebo, followed by an open-label injection of tgAAC94
after 12 to 30 weeks, depending on when swelling in the target
joint meets criteria for re-injection. As of May 2006, 21 subjects
in the first cohort, 10 of whom were receiving concurrent TNF-alpha
antagonists, received an injection of blinded study drug into the
knee (n=12), ankle (n=4), wrist (n=2) or metacarpophalangeal joint
(n=3). No significant safety concerns have been identified after 12
to 24 weeks of follow-up. Fewer patients receiving tgAAC94 had
symptoms requiring re-injection at the 12-week time point, compared
with patients in the placebo arm. The data also suggest a trend
toward improvement in tenderness and swelling of the injected joint
in patients receiving tgAAC94. These improvements were noted in
subjects taking concurrent systemic TNF-alpha antagonist therapy as
well as those subjects not on these therapies. "I have been very
impressed with the responses observed in patients from my practice
who have participated in clinical trials of tgAAC94," said Edward
J. Fudman, M.D., President, Austin Rheumatology Research. "Although
these patients had residual disease despite treatment with other
agents, including systemic TNF-alpha antagonists, they have
experienced improvements in the signs and symptoms of disease in
joints treated with tgAAC94. I am optimistic that tgAAC94 will
continue to show benefit in this patient population and believe
that this investigational therapeutic may have an important role to
play in the treatment of inflammatory arthritis." H. Stewart
Parker, President and Chief Executive Officer of Targeted Genetics,
added, "The selection of this abstract for presentation at the
leading European arthritis conference reflects the growing interest
in tgAAC94 among physicians who treat inflammatory arthritis in
their daily practices. We are pleased to have the opportunity to
share the promising results of our tgAAC94 clinical studies with
these members of the medical community and will continue to use
opportunities like these to further educate our constituents about
the potential of targeted localized protein therapy for
inflammatory arthritis." About tgAAC94 tgAAC94 is being developed
as a potential supplement to systemic anti-TNF-alpha protein
therapy for use in patients with inflammatory arthritis who have
one or more joints that do not respond to systemic protein therapy.
The product candidate uses Targeted Genetics' recombinant AAV
(rAAV) vector technology to deliver a DNA sequence that encodes a
soluble form of the TNF-alpha receptor (TNFR:Fc). Soluble TNFR
inhibits the immune stimulating activity of TNF-alpha. Direct
injection of tgAAC94 into affected joints leads to the localized
production of secreted TNFR within joint cells, reducing the
activity of TNF-alpha within the joint and, potentially, leading to
a decrease in the signs and symptoms of inflammatory disease and
inhibition of joint destruction. The Company's rAAV technology
platform is used to deliver genes and is based on AAV, a naturally
occurring virus that has not been associated with any disease in
humans. About Targeted Genetics Targeted Genetics Corporation is a
biotechnology company committed to the development and
commercialization of innovative, targeted molecular therapies for
the prevention and treatment of inflammatory arthritis, HIV/AIDS
and other acquired and inherited diseases with significant unmet
medical need. Targeted Genetics uses its considerable knowledge and
capabilities in the development and manufacturing of gene delivery
technologies to advance a diverse product development pipeline. Its
product development efforts target inflammatory arthritis,
HIV/AIDS, congestive heart failure, Huntington's disease, and
hyperlipidemia. To learn more about Targeted Genetics, visit its
website at www.targetedgenetics.com. Safe Harbor Statement under
the Private Securities Litigation Reform Act of 1995: This release
contains forward-looking statements regarding the data to be
collected in this trial, the establishment or determination of
efficacy endpoints from the data collected in the trial, the timely
and complete accrual of patients in the trial and our ability to
commercialize tgAAC94 and other statements about our 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
our actual results include, but are not limited to, our ability to
obtain, maintain and protect our intellectual property, our ability
to raise capital when needed, our ability to recruit and enroll
suitable trial participants, the timing, nature and results of
research and clinical trials, potential development of alternative
technologies or more effective processes by competitors, and, our
ability to obtain and maintain regulatory or institutional
approvals, as well as other risk factors described in Item 1A. Risk
Factors in our report on Form 10-K for the year ended December 31,
2005 and updated in Item 1A. Risk Factors in our Form 10-Q for the
quarter ended March 31, 2006. You should not rely unduly on these
forward-looking statements, which apply only as of the date of this
release. We undertake no duty to publicly announce or report
revisions to these statements as new information becomes available
that may change our expectations.
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