SEATTLE, WA, Aug 06, 2007 (MARKET WIRE via COMTEX News Network) -- Targeted Genetics Corporation (NASDAQ: TGEN) responded to an article
in today's Washington Post with respect to its development program of
tgAAC94, an investigational therapy for the treatment of inflammatory
arthritis. The Company believes that it is unfortunate that the
article seems designed to agitate as opposed to inform. The incident
central to the article currently is being assessed by the Company and
the FDA, and the Company believes that it would be premature as well
as irresponsible to draw any conclusions prior to the completion of
that investigation.
The Company and the FDA stopped the trial in a timely manner due to
uncertainty of the cause of a serious adverse event (SAE), but as has
been stated previously, there is currently insufficient information to
draw conclusions as to the cause. This patient's course of illness
is not consistent with the Company's previous clinical experience in
the 130 patients who have received tgAAC94 to date; nor is it
consistent in the more than 300 patients that have been treated in
the Company's AAV clinical trials in total.
"Patient safety is of paramount importance and we have designed and
conducted all of our trials with that in mind. We are confident in
the safety of our product and platform and look forward to the
opportunity to complete the clinical trials, which is the only way to
determine the efficacy and safety profile of this or any other drug
candidate," said H. Stewart Parker, president and chief executive
officer of Targeted Genetics.
"All of us at Targeted Genetics are deeply saddened by the unexpected
death of this patient, and while our ability to communicate around
this event is limited by both patient privacy and FDA regulations, we
are committed to being as transparent as possible with respect to our
activities prior to the patient's death and to sharing additional
information as it becomes available," added Parker.
Patient Safety Chronology of Reporting
"We shared a very detailed chronology of our analyses and reporting
activities regarding this particular study patient with the reporter
from the Washington Post, which demonstrated how we acted in strictest
compliance with today's best clinical trial practices, and which was
not included in the article," said Parker.
In February, 2007, the patient was enrolled into the clinical trial
for tgAAC94, and received the first dose. The patient received a
second dose of tgAAC94 on July 2nd.
On July 10th, the clinical investigator reported to Targeted Genetics
that two patients had nausea, fever and vomiting. These are not
uncommon events and were recorded as adverse events (AEs). The
investigator advised that these adverse events were not related to
study drug. Consistent with FDA regulatory procedures and the study
protocol, these adverse events were noted and will be reported to the
FDA in the study's annual report.
On July 13th, Targeted Genetics was notified that this patient had
been hospitalized, which is considered a serious adverse event (SAE).
The investigator reported at this time that the SAE was unlikely
related to study drug, and the event was noted and held for
submission in the annual report. The second patient's symptoms had
resolved.
On July 17th, the investigator notified us that the patient's
condition was deteriorating, and reiterated that the SAE was
unrelated to study drug. Although this information did not trigger a
reporting requirement to the FDA, the Company proactively notified
the chairman of its independent data safety monitoring board, or
DSMB, about the situation on July 18th.
On the 19th, the Company notified the full DSMB. After a
comprehensive analysis in concert with the DSMB, due to the temporal
relationship between dosing and the onset of the event, the Company
decided to report the SAE to the FDA as possibly related to study
drug.
Although FDA requirements are that SAEs possibly related to study
drug must be reported within a week, the Company held a
teleconference on July 20th with the FDA and the clinical
investigator involved in this case, within 24 hours of making the
determination that the SAE was possibly related to drug. The trial
was officially put on hold and all study sites were notified. The
official IND safety report was filed on July 23rd.
Study Safety Reported to Date
In the Phase I/II study, 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 its impact,
if any, on the timing, continuance or results of this trial. 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.
Investor and Media Contact:
Stacie D. Byars
Director, Communications
Targeted Genetics Corporation
(206) 521-7392
SOURCE: Targeted Genetics