AMSTERDAM, Netherlands & SEATTLE--(BUSINESS WIRE)--Aug. 30,
2006--Targeted Genetics Corporation (Nasdaq:TGEN) announced that
Nathan Clumeck, M.D., Ph.D., Head of the Department of Infectious
Diseases, St. Pierre University Hospital in Brussels, Belgium, will
present interim results today from a Phase I clinical trial of
tgAAC09, an investigational HIV/AIDS vaccine candidate based on
recombinant adeno-associated virus vector serotype 2 (AAV2). The
trials for tgAAC09 are being conducted in collaboration with the
International AIDS Vaccine Initiative (IAVI). The trial, enrolling
healthy volunteers who are not infected with HIV, was conducted in
Belgium and Germany, and is ongoing in India. Professor Clumeck is a
principal investigator for this study and will present this data at
the AIDS Vaccine 2006 Conference, taking place August 29 until
September 1, 2006, in Amsterdam, Netherlands. A second clinical trial
of tgAAC09 is ongoing in South Africa, Uganda and Zambia to evaluate a
higher dose and to systematically evaluate the utility and optimal
timing of boost vaccination.
The Phase I trial is the first ever to test a recombinant
AAV-based vaccine and is primarily designed to evaluate safety and
tolerability of the vaccine at escalating dose levels. The study is
also designed to evaluate immune responses following vaccination. No
safety concerns were identified and the vaccine was well tolerated. In
a subset of the volunteers receiving a single administration of the
highest dose of the vaccine, modest immune responses were observed.
Further studies are planned to determine the clinical relevance of
this observation.
"We are very encouraged by the immune responses observed in a
subset of patients receiving the highest dose of tgAAC09 in this
study," said H. Stewart Parker, President and Chief Executive Officer
of Targeted Genetics. "This is the first human evidence that an
AAV-based vaccine can stimulate the immune system to respond to HIV
proteins. While these data require confirmation and additional
analysis, they provide critical insight into the activity of tgAAC09
that will help inform our comprehensive development program for
AAV-based vaccines designed to protect against HIV/AIDS. In
conjunction with data from other trials evaluating higher doses of
tgAAC09 and a variety of dosing schedules, these data support our
efforts to develop a vaccine that has the potential to impact the
global HIV/AIDS pandemic."
About the Clinical Program
The Phase I clinical trial is a double-blind, placebo-controlled,
dose-escalation safety study that also monitors immune responses to
the product candidate. The portion of the study conducted in Belgium
and Germany enrolled 50 volunteers who were in good general health and
not infected with HIV. The portion of the trial being conducted in
India enrolled 30 healthy HIV-negative volunteers. Each volunteer
received a single intramuscular injection into the upper arm. A subset
of volunteers also received a second dose of the vaccine to determine
if repeat dosing is safe, and if it boosts immune responses. The Phase
I trial in Germany, Belgium and India is being conducted in
collaboration with researchers at Columbus Children's Research
Institute and The Children's Hospital of Philadelphia.
A Phase II trial of a vaccine based on AAV2 is being conducted in
collaboration with the Chris Hani Baragwanath Hospital, the Desmond
Tutu Institute for HIV Research and the University of Limpopo in South
Africa; the Uganda Virus Research Institute; and the Zambia Emory HIV
Research Project. This trial is being conducted in order to evaluate
the potential impact of a higher dose of tgAAC09 and boost vaccination
on the strength and duration of immune responses.
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 tgAAC09 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 partners ability to recruit and enroll
suitable trial participants, our partners continued support of this
clinical program, 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, 2005, and updated in Item 1A.
Risk Factors in our subsequent reports on Form 10-Q. 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.
CONTACT: Targeted Genetics Corporation
Stacie D. Byars, 206-521-7392
SOURCE: Targeted Genetics Corporation
