Targeted Genetics Presents Encouraging Interim Data From an Ongoing Phase I/II Trial of tgAAC94 in Patients with Inflammatory A
June 01 2006 - 7:00AM
Business Wire
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.
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