Targeted Genetics Presents Additional Data from Its Inflammatory Arthritis Program at the 13th Annual Congress of the European S
31 10์ 2005 - 9:30PM
Business Wire
Targeted Genetics Corporation (Nasdaq:TGEN) -- Results demonstrate
safety and reduction of mean tenderness and swelling scores of the
treated joint; results support continued study of tgAAC94 in
conjunction with TNF-alpha antagonists in inflammatory arthritis
Targeted Genetics Corporation (Nasdaq:TGEN) presents additional
results from its initial Phase I clinical trial of tgAAC94 in
patients with inflammatory arthritis, in a poster session during
the 13th Annual Congress of the European Society of Gene Therapy in
Prague, Czech Republic, October 29-November 1. Barrie J. Carter,
Ph.D., Executive Vice President and Chief Scientific Officer at
Targeted Genetics, is presenting the data in a poster session at
the conference. This presentation highlights data from the Phase I
clinical study evaluating the safety of intra-articular injection
of two escalating dose levels of tgAAC94 in patients not on
concomitant systemic TNF-alpha antagonist therapy. The Phase I
clinical trial was designed to evaluate safety of a single dose of
tgAAC94 injected locally into the arthritic joint of subjects
suffering from inflammatory arthritis. Enrollment was limited to
those not currently on concomitant TNF-alpha antagonist therapies.
Fifteen subjects who enrolled in the trial were randomized to
receive either one of two escalating dose levels of tgAAC94 (n=11)
or a placebo (n=4). The trial contained a placebo arm at each dose
level, which was included to assess safety and determine whether
any adverse events were attributable to an intra-articular
injection itself, as opposed to an intra-articular injection of
tgAAC94. Preliminary safety data were previously reported by the
Company after all subjects had been evaluated for 4 weeks after
injection. Secondary endpoints were also reported on a subset of
subjects that had completed up to eight weeks of follow-up. In
those treated with tgAAC94 and followed for up to eight weeks,
there was an indication of sustained improvement in signs and
symptoms of disease in injected joints. The trial is closed for
enrollment and patients will continue to be followed for 24 weeks
after injection. All subjects have now been followed for at least
12 weeks after injection of tgAAC94 or placebo. Data presented at
this time point demonstrate that: -- Intra-articular injections of
tgAAC94 were safe and well-tolerated at doses up to 1x10(11) DRP
per mL of joint volume among patients currently taking conventional
disease modifying anti-rheumatic drugs (DMARDS). -- No drug-related
serious adverse events have been reported to date (n=11). --
Although the study is not powered to show efficacy, in those
treated with a single dose of tgAAC94, continued measurable
improvements in swelling and tenderness were observed (n=11). The
reduction in mean scores appears to be greater at the higher dose,
suggesting a dose to response correlation (n=6). There was some
improvement noted in mean tenderness and swelling scores in
subjects receiving placebo (n=4). These subjects were primarily
included for safety analysis. -- In the non-injected joints of the
tgAAC94 treated groups there also appears to be a trend in the
decrease in mean tenderness and swelling scores over time, which
was not observed in the subjects receiving placebo. "I am very
encouraged that the results from later time points in the study
continue to demonstrate the safety of injecting tgAAC94 directly
into affected joints, and the observed trends in improvements in
tenderness and swelling scores of treated joints persist," said
Carter. "We believe that the data presented today support the
potential of our experimental therapeutic product, tgAAC94, to
treat patients who suffer with inflammatory arthritis. We are
excited to have recently initiated our next Phase I clinical study
in patients with inflammatory arthritis who have not experienced an
adequate response to anti-TNF-alpha therapy and who might have
ongoing destructive inflammation in select joints." About the
Follow-on Phase I Clinical Trial of tgAAC94 In October, 2005,
Targeted Genetics initiated a follow-on Phase I clinical trial of
tgAAC94 administered directly to affected joints of patients with
inflammatory arthritis who may be receiving concomitant systemic
TNF-alpha antagonist therapy. The study is designed to enroll up to
40 subjects and will evaluate tgAAC94 at two dose levels in
patients with rheumatoid arthritis, psoriatic arthritis or
ankylosing spondylitis and who may be receiving concomitant
treatments of anti-TNF-alpha therapy. tgAAC94 is being developed
initially as a complementary therapy for patients who may not
achieve adequate relief with existing arthritis treatments or
others who have disease limited to a few joints and therefore, may
not need systemic protein therapies. This targeted, localized
approach to treatment is intended to provide therapeutic benefit
that will enable patients to achieve better control and relief of
the signs and symptoms of their disease. In the first segment of
the double-blind, placebo-controlled study, subjects will receive a
single intra-articular injection of tgAAC94 or placebo in the
affected joint and be monitored until swelling in the target joint
reaches pre-determined criteria for re-injection. At that time,
both tgAAC94-injected subjects and those initially injected with
placebo will receive a second injection of tgAAC94 in the affected
joint as part of the open-label segment of the study. The primary
endpoint of the study is to establish the safety of a higher dose
and of repeat administration of tgAAC94 into the joints of subjects
with or without concomitant TNF-alpha inhibitor therapy. Secondary
endpoints include evaluation of pain, swelling, duration of
response, and overall disease activity following intra-articular
administration of tgAAC94 to affected joints, as well as molecular
markers of disease. Additionally, changes in joint inflammation and
joint damage will be assessed in a subset of patients using
magnetic resonance imaging. About tgAAC94 tgAAC94 uses Targeted
Genetics' recombinant AAV (rAAV) vector technology and contains a
gene 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 soluble TNFR by the patient's joint
cells. Localized production of TNFR reduces the activity of
TNF-alpha within the joint, potentially leading to a decrease in
the signs and symptoms of inflammatory disease and inhibition of
joint destruction. Preclinical studies have demonstrated the
efficacy of tgAAC94 in reducing inflammation and joint damage. Data
from preclinical studies conducted in an animal model of
inflammatory arthritis demonstrated that a single injection of rAAV
encoding a soluble form of the rat TNFR:Fc vector into the ankles
of arthritic rats resulted in a significant reduction in ankle and
hind paw swelling as measured by arthritis index scores. 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. Local administration of a DNA
sequence encoding a soluble TNFR potentially may supplement
currently used drugs in a number of inflammatory conditions. In
addition, a locally administered anti-TNF-alpha therapy could also
be useful in patients who have a limited number of joints affected
by inflammatory arthritis that are at a risk for progressive joint
damage but who may not require systemic therapy. The
characteristics of AAV vectors make them well suited for delivery
of genetic material to joints and other organs. 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 and
other acquired and inherited diseases with significant unmet
medical need. We use our considerable knowledge and capabilities in
the development and manufacturing of gene delivery technologies to
advance a diverse product development pipeline. Our product
development efforts target inflammatory arthritis, AIDS
prophylaxis, congestive heart failure, Huntington's disease and
hyperlipidemia. To learn more about Targeted Genetics, visit our
website at: www.targetedgenetics.com. Safe Harbor Statement under
the Private Securities Litigation Reform Act of 1995: This release
contains forward-looking statements regarding our intellectual
property, research programs and clinical trials, our product
development and our potential development platforms including
tgAAC94 and other statements about our plans, objectives,
intentions and expectations. In particular, the statements
regarding the Company's pipeline, ability to maintain patients in
the trial for follow-up and future clinical trial plans are
forward-looking statements. 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, initial trial results not
indicative of results from the completion of the trial, the timing,
nature and results of our clinical trials, potential development of
alternative technologies or more effective products by competitors,
our ability to obtain and maintain regulatory or institutional
approvals, our ability to obtain, maintain and protect our
intellectual property and our ability to raise capital when needed,
as well as other risk factors described in the section entitled
"Factors Affecting Our Operating Results, Our Business and Our
Stock Price" in our Quarterly Report on Form 10-Q for the period
ended June 30, 2005. 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.
Tecogen (NASDAQ:TGEN)
๊ณผ๊ฑฐ ๋ฐ์ดํฐ ์ฃผ์ ์ฐจํธ
๋ถํฐ 6์(6) 2024 ์ผ๋ก 7์(7) 2024
Tecogen (NASDAQ:TGEN)
๊ณผ๊ฑฐ ๋ฐ์ดํฐ ์ฃผ์ ์ฐจํธ
๋ถํฐ 7์(7) 2023 ์ผ๋ก 7์(7) 2024