Full Press Release Details
Genetics Corporation
I DATA FROM TARGETED GENETICS' tgAAC09 VACCINE FOR HIV/AIDS
AT SCIENTIFIC CONFERENCE
February 28, 2007 - Targeted Genetics Corporation (Nasdaq: TGEN) today announced
that Dr. Jan van Lunzen, Medical Director, University Medical Center, Hamburg
Eppendorf, Germany, presented updated Phase I data from a study of tgAAC09
healthy volunteers not infected with HIV in a poster presentation at the
Conference on Retroviruses and Opportunistic Infections in Los Angeles. The
tgAAC09 vaccine candidate utilizes an adeno-associated virus (AAV) vector to
deliver genes encoding HIV proteins and is designed to stimulate an immune
response against HIV. Targeted Genetics, the International AIDS Vaccine
Initiative (IAVI) and researchers at Columbus Children's Research Center and
Children's Hospital of Philadelphia are collaborating on the development of
tgAAC09 and other AAV-based HIV vaccines.
results reported today reinforce the favorable safety and tolerability profiles
of tgAAC09 observed in clinical trials to date, and provide the rationale for
evaluating the vaccine at higher doses and at different dosing intervals," said
H. Stewart Parker, president and chief executive officer of Targeted Genetics.
"We have a Phase II clinical study of tgAAC09 at higher doses currently underway
at multiple sites in South Africa, Zambia and Uganda, and are continuing to
with our collaborators to explore additional vaccine constructs comprising
AAV serotypes and HIV genes. We believe that AAV-based vaccines may play an
important role in mitigating the global HIV/AIDS pandemic."
Phase I study, 80 healthy volunteers in Europe and India received a single
intramuscular injection of tgAAC09 at different doses. Additionally, 21 of
50 European volunteers received a booster vaccination of either tgAAC09 at
highest dose tested, or placebo. The results presented today demonstrate that
vaccination with tgAAC09 appears to be safe and well tolerated and stimulated
modest immune response against gag,
principal HIV protein encoded by tgAAC09. In animal models, tgAAC09 elicited
both T- and B-cell responses. In this trial, HIV-specific T-cell responses
observed in 20 percent of participants receiving the highest dose of tgAAC09
tested; however antibody responses were not observed.
the responses in this study are modest overall, it is very encouraging to see
20% participant response at this dose threshold," said Dr. van Lunzen. "Given
the dose-response relationship observed in this trial, it is our hope that
higher doses may enhance the vigor of the immune response elicited by tgAAC09.
Further study of this and other AAV-based vaccines is warranted, as they provide
a novel approach for using the power of the immune system to fight such a
devastating infection."
the tgAAC09 Clinical Program
I clinical trial is a double-blind, placebo-controlled, dose-escalation safety
study that also monitors immune responses to HIV antigens. 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-uninfected 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
II trial of a vaccine based on AAV2 is being conducted in collaboration with
Chris Hani Baragwanath Hospital, the Desmond Tutu Institute for HIV Research
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.
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
to deliver genes encoding proteins to increase gene function, as well as RNAi
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
the Company's website at www.targetedgenetics.com.
Harbor Statement under the Private Securities Litigation Reform Act of
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, the timely and complete accrual of patients in
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
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
competitors, and, our ability to obtain and maintain regulatory or institutional
approvals, as well as other risk factors described in Item 1A. Risk Factors
our report on Form 10-K for the year ended December 31, 2005 and updated in
1A. Risk Factors in our Form 10-Q for the quarter ended September 30, 2006.
should not rely unduly on these forward-looking statements, which apply only
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.