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Targeted
Genetics Reports On Recombinant DNA Advisory Committee (RAC) Review Of
Its Phase 1/2 Trial Of TgAAC94 For Rheumatoid Arthritis
18
Sept 2007
As
edited by Joint-Pain-Forum.com
Targeted
Genetics Corporation (Nasdaq: TGEN) reported on the public hearing
conducted by the National Institutes of Health (NIH) Recombinant DNA
Advisory Committee (RAC), which reviewed the serious adverse event
reported by Targeted Genetics surrounding the death of a patient
participating in the Company's Phase I/II trial of tgAAC94 for
inflammatory arthritis.
The clinical case was
presented for the first time in a comprehensive manner and showed that
histoplasmosis played a significant role in the cause of the patient's
death. Initial molecular tests showed there was no replication of
vector and only trace amounts of vector DNA in tissues outside the
joint. Consequently, these data suggest it is unlikely that tgAAC94
contributed to the conditions that caused the death. Molecular tests
are being conducted in remaining tissues and Targeted Genetics will
continue to collaboratively work with academic colleagues, RAC, FDA and
other involved parties to complete the investigation.
"While
additional tests are needed to draw final conclusions, we believe the
results to date are consistent with preclinical and clinical findings
that indicate the level of vector that is present outside the locally
treated area is insufficient to have further exacerbated an infection,"
said H. Stewart Parker, president and chief executive officer of
Targeted Genetics.
Barrie J. Carter, Ph.D.,
executive vice president and chief scientific officer of Targeted
Genetics added, "A gene therapy approach may have enormous potential to
improve the treatment of rheumatoid arthritis, a disease that leads to
profound morbidity and premature mortality. It is critical that we let
the clinical trial and scientific process determine the risks and
potential of gene therapy before rushing to judgment and hampering the
development of what could one day play a significant role in the
treatment of serious diseases."
About
Histoplasmosis
Histoplasmosis is a fungal
infection resulting from exposure to spores of the microscopic fungus,
Histoplasma capsulatum. Clinical manifestations can vary from a mild
flu-like illness that may not produce any noticeable symptoms to
rapidly progressive, sometimes fatal, disseminated disease. The degree
of symptoms experienced from this infection can be highly variable
depending on a number of factors including the relative strength of the
infected person's immune system. Many of the medications commonly
prescribed to patients undergoing treatment for inflammatory arthritis,
including those that were being taken by the patient, are recognized to
have immunosuppressant effects.
----------------------------
Article
adapted by
www.Joint-Pain-Forum.com from original press release.
----------------------------
About tgAAC94 and the Phase
I/II Study
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
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. 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 into the knee,
ankle, wrist, metacarpophalangeal or elbow, and 74 subjects out of the
total 127 have received a second dose of active drug. Of those 74
subjects, 55 have received two doses of active drug.
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 http://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 June 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.
Targeted Genetics
Corporation
http://www.targetedgenetics.com
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