Encouraging Interim Results from a Phase I/II Trial of Targeted Genetics' tgAAC94 in Patients with Inflammatory Arthritis; Inte
05 June 2006 - 10:00PM
Business Wire
Targeted Genetics Corporation (Nasdaq:TGEND) reported preliminary
efficacy data from its ongoing Phase I/II trial of tgAAC94 in
patients with inflammatory arthritis yesterday at the American
Society of Gene Therapy (ASGT) 2006 Annual Meeting. Alison Heald,
M.D., Senior Director, Clinical Affairs at Targeted Genetics
presented preliminary efficacy data from the first two cohorts of
the Phase I/II trials in a talk, titled "Clinical Studies of
Intra-Articular Administration of a Recombinant Adeno-Associated
Vector Contain a TNF-alpha Antagonist Gene in Inflammatory
Arthritis," in an oral abstract session on bone and joint disease.
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. "The past few years have brought significant advances in
the treatment of inflammatory arthritis, however many patients
still experience significant unmet medical need despite treatment
with systemic agents," said H. Stewart Parker, president and chief
executive officer of Targeted Genetics. "Although still at an early
stage, the results of the trial so far suggest that local
administration of tgAAC94 directly to affected joints may induce a
treatment effect and we believe lay the groundwork to
commercialization of the first gene therapeutic for rheumatoid
arthritis. We are very encouraged by these interim results, and
plan to report data on additional subjects in November 2006." 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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