Full Press Release Details
Genetics Corporation
GENETICS COMPLETES ENROLLMENT AND INITIAL DOSING OF tgAAC94 PHASE I/II TRIAL
PATIENTS WITH INFLAMMATORY ARTHRITIS
24, 2007 - Targeted Genetics Corporation (Nasdaq: TGEN) today announced that
has achieved its enrollment target of 120 patients in its ongoing Phase I/II
clinical trial of tgAAC94. The study is designed to assess the safety and
potential efficacy of different doses of tgAAC94 administered directly to
affected joints of patients with inflammatory arthritis. tgAAC94 is an
investigational therapy that utilizes an adeno-associated virus (AAV) vector
deliver the gene encoding a soluble form of the receptor for TNF-alpha (TNFR:
Fc). The TNFR:Fc protein is a potent inhibitor of tumor necrosis factor-alpha
(TNF-alpha), a key mediator of inflammation.
pleased with the rapid pace of enrollment in this study, and believe that it
reflects the substantial unmet medical needs of patients with inflammatory
arthritis," said H. Stewart Parker, president and chief executive officer of
Targeted Genetics. "Interim data suggest that tgAAC94 reduces tenderness and
swelling in treated joints in patients whether or not they are taking
concomitant systemic TNF-alpha antagonist therapy. Completing enrollment and
initial dosing in this trial is an important step in the development of tgAAC94.
We expect to present additional interim data from the trial at multiple
scientific venues during 2007, and data from the completed study in
ongoing Phase I/II study, 120 adults were randomized into three dose levels
receive a single intra-articular injection of either tgAAC94 or placebo into
knee, ankle, wrist, metacarpophalangeal or elbow, followed by an open-label
injection of tgAAC94 after 12 to 30 weeks, depending on when arthritis symptoms
in the target joint meet criteria for re-injection. Following the second
injection, all subjects are followed for an additional 30 weeks.
data from the study were reported in February 2007 on 61 subjects randomized
into three dose cohorts. The data support the safety and tolerability of single
and repeat intra-articular injections of tgAAC94 to affected joints at doses
to 1x10(13) DNase Resistant Particles per milli-liter (DRP/mL) of joint fluid
subjects with and without systemic TNF-alpha antagonists. The data continue
suggest that treatment with tgAAC94 may lead to improvements in signs and
symptoms of arthritis in injected joints.
data from this study were also presented at the American College of Rheumatology
Annual Scientific meeting in November 2006. Investigators reported that among
the first 41 subjects randomized to the two lower doses of tgAAC94 or placebo,
of 10 subjects (70%) who received placebo qualified for open label tgAAC94
to 30 weeks, in contrast to 16 of 31 subjects (52%) who received tgAAC94. The
median time to second injection was 120, 129 and 145 days for subjects who
received placebo, tgAAC94 1x10(11) DRP/mL and tgAAC94 1x10(12) DRP/mL,
clinical study design will be based on results from the ongoing Phase I/II
clinical study and initiation of the next trial is anticipated for the first
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 fully respond to systemic protein therapy. The product
candidate uses Targeted Genetics' recombinant AAV (rAAV) vector technology
deliver a DNA sequence that encodes a soluble form of the TNF-alpha receptor
(TNFR: Fc). Soluble TNFR:Fc inhibits the immune stimulating activity of
TNF-alpha. Direct injection of tgAAC94 into affected joints leads to the
localized production of secreted TNFR:Fc 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
is based on AAV, a naturally occurring virus that has not been associated with
any disease in humans.
Genetics Corporation is a biotechnology company committed to the development
innovative targeted molecular therapies for the prevention and treatment of
acquired and inherited diseases with significant unmet medical need. Targeted
Genetics' proprietary Adeno-Associated Virus (AAV) technology platform allows it
to deliver genes that encode proteins to increase gene function or RNAi to
decrease or silence gene function. Targeted Genetics' product development
efforts target inflammatory arthritis, AIDS prophylaxis, congestive heart
failure and Huntington's disease. To learn more about Targeted Genetics, visit
Targeted Genetics' website at www.targetedgenetics.com.
Harbor Statement under the Private Securities Litigation Reform Act of 1995:
release contains forward-looking statements regarding the data to be collected
in this trial, the establishment or determination of efficacy endpoints from
data collected 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
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
enroll suitable trial participants for future trials, 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
factors described in Item 1A. Risk Factors in our report on Form 10-K for the
year ended December 31, 2006 and updated in Item 1A. Risk Factors in our Form
10-Q for the quarter ended March 31, 2007. You should not rely unduly on these
forward-looking statements, which apply only as of the date of this release.
undertake no duty to publicly announce or report revisions to these statements
as new information becomes available that may change our expectations.