Targeted Genetics (NASDAQ:TGEND)
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Preliminary Data Show Positive Trends toward Sustained Improvement in
Signs and Symptoms of Disease
Targeted Genetics Corporation (Nasdaq:TGEND) will present interim
data from its ongoing Phase I/II trial of tgAAC94 in patients with
inflammatory arthritis today at the American Society of Gene Therapy
(ASGT) 2006 Annual Meeting. Pervin Anklesaria, Ph.D., Vice President,
Therapeutic Development at Targeted Genetics, will present highlights
of initial data from the ongoing Phase I/II and a summary of the
recently completed Phase I clinical trials of tgAAC94. The data will
be presented in an oral presentation, titled "Clinical Development of
an AAV Vector Expressing the TNF Receptor: Fc Fusion Gene in
Inflammatory Arthritis," as part of a workshop on musculoskeletal gene
expression and Immunology of musculoskeletal gene therapy. The Company
will hold a conference call with investors and analysts at 4:30 PM
Eastern Time today. The call will be broadcast live and can be
accessed, along with replay information, at www.targetedgenetics.com.
tgAAC94 utilizes an adeno-associated virus (AAV) vector to deliver
the gene encoding a soluble form of the receptor for tumor necrosis
factor-alpha (TNFR:Fc) directly to affected joints. TNFR:Fc protein is
a potent inhibitor of tumor necrosis factor alpha (TNF-alpha), a key
mediator of inflammation.
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.
Entry criteria for this study are similar to that of the Phase I
trial, except that concurrent TNF-alpha antagonist use is permitted in
the Phase I/II trial. To date, approximately 40 subjects have received
an injection of blinded study drug or placebo.
Preliminary data indicate tgAAC94 is safe and well-tolerated at
doses of up to 5x10(12) particles (DRP) /mL in subjects with and
without systemic TNF-alpha antagonists. Data from the first cohort of
subjects treated with doses of 1x10(11) (DRP)/mL of joint volume
demonstrate a trend toward sustained improvement in tenderness and
swelling in treated joints, compared to placebo. Additionally, fewer
patients receiving tgAAC94 had symptoms requiring re-injection at the
12-week time point, compared with patients in the placebo arm.
Although the numbers are small, the data also suggest a trend toward
greater responses to tgAAC94 in patients taking systemic TNF-alpha
antagonist therapy compared with patients not on these therapies.
Additional details of the trial design and data from this Phase I/II
trial will be presented on Sunday in a separate session at the ASGT
meeting (abstract #1092).
"tgAAC94 represents a promising new approach in treating
inflammatory arthritis and we are very encouraged by the data thus far
from this Phase I/II study in patients with inflammatory arthritis,"
said Philip Mease, M.D., Chief, Rheumatology Clinical Research
Division of Swedish Hospital Medical Center, Head of Seattle
Rheumatology Associates, and a lead investigator in this clinical
trial. "We have observed very favorable safety and toxicity profiles
at the first two dose levels and have seen trends toward improvement.
The data suggest that a single, intra-articular injection of tgAAC94
resulted in measurable and sustained reductions in pain and swelling.
Given the number of inflammatory arthritis patients who still
experience unresolved symptoms despite treatment with systemic
TNF-alpha antagonist therapy, there is a compelling need to explore
additional approaches to treatment, and we believe that tgAAC94 may
have significant potential in improving the long-term management of
this disease."
H. Stewart Parker, president and chief executive officer of
Targeted Genetics added: "We are encouraged by this interim data and
believe that Targeted Genetics' unique approach for localized delivery
of a protein therapeutic may provide patients suffering with
inflammatory arthritis additional treatment options as part of their
disease management regimens. Importantly, this data helps us to
further understand the potential of this lead product opportunity, in
particular as we seek additional product opportunities in therapeutic
areas of interest that are complementary to our program in
inflammatory arthritis and as we pursue ways to further leverage our
investment in AAV manufacturing and scale up, through strategic
collaborations."
Dr. Anklesaria will also present the data from a completed Phase I
trial of tgAAC94. As previously reported, the safety of
intra-articular administration of tgAAC94 in inflammatory arthritis
was first evaluated in a Phase I study in patients not on TNF-alpha
antagonists and with persistent moderate or severe inflammation in a
target joint due to inflammatory arthritis. Fifteen patients (14 with
rheumatoid arthritis and 1 with ankylosing spondylitis) received a
single intra-articular injection of either tgAAC94 or placebo in two
escalating dose cohorts and were followed for 24 weeks. A trend in
sustained improvement in a composite tenderness and swelling score was
noted in all treatment groups, particularly among subjects who
received the higher dose of tgAAC94. Some improvement was noted in
mean tenderness and swelling scores in subjects receiving placebo,
although the study was not powered to interpret this statistically.
Conference call and Webcast information
The company will host a conference call providing an update on the
development progress of the Company's lead clinical program in
inflammatory today beginning at 4:30 p.m. Eastern Time / 1:30 p.m.
Pacific Time. You may access the live webcast via the homepage of the
Company's website at www.targetedgenetics.com or via telephone at
800-240-5318 (domestic) or 303-262-2138 (international).
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 soluble 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, our expected use of these proceeds 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 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.