SEATTLE, WA, Jul 24, 2007 (MARKET WIRE via COMTEX News Network) -- Targeted Genetics Corporation (NASDAQ: TGEN) announced that after
recent discussions with the United States Food and Drug
Administration (FDA), the development program of tgAAC94, an
investigational therapy for the treatment of inflammatory arthritis,
has been placed on clinical hold.
As a precautionary measure, the FDA stopped further administration of
tgAAC94 due to the uncertainty of the cause of a serious adverse
event (SAE) that occurred in one subject enrolled in the study.
Currently, there is insufficient information to draw conclusions as
to the cause of the SAE, and therefore the study will remain on
clinical hold while additional data is gathered and analyzed.
Subjects already enrolled in the study will continue to be followed
and monitored. Since the trial began in October 2005, 127 subjects
have received an initial dose of active drug or placebo, and 74
subjects out of the total 127 have received a second dose of active
drug.
"Our primary concern remains that of the safety of the patients, and
we are working diligently with the study's Data Safety Monitoring
Board and the FDA to determine the cause of this unexpected event as
quickly as possible," said H. Stewart Parker, president and chief
executive officer of Targeted Genetics.
The Phase I/II study is designed to assess the safety and potential
efficacy of different doses of tgAAC94 administered directly to
affected joints of subjects with inflammatory arthritis. tgAAC94 is an
investigational therapy that utilizes an adeno-associated virus (AAV)
vector to 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. In March 2006, the Company received approval from the
FDA to amend its protocol for the tgAAC94 clinical trial to include a
higher dose group and increase the number of patients. 127 adults
have been randomized into three dose levels to receive a single
intra-articular injection of either tgAAC94 or placebo into the 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.
The interim data reported by our investigators at leading scientific
meetings in June 2006, November 2006 and June 2007, support the
safety and tolerability of single and repeat intra-articular
injections of tgAAC94 to affected joints at doses up to 1x10(13)
DNase Resistant Particles per milli-liter (DRP/mL) of joint fluid in
subjects with and without systemic TNF-alpha antagonists. This
interim data also suggest that treatment with tgAAC94 may lead to
improvements in signs and symptoms of arthritis in injected joints.
About tgAAC94
tgAAC94 is being developed as a supplemental therapeutic 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 to 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 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 of 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.
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 cause of the SAE and the impact,
if any, on the timing continuance or results of this trial,
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 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 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 30, 2007. 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.
SOURCE: Targeted Genetics