Full Press Release Details
Genetics Corporation
DATA FROM TARGETED GENETICS' PHASE I HIV/AIDS VACCINE TRIAL
BE PRESENTED AT LEADING EUROPEAN AIDS VACCINE MEETING
candidate well tolerated; modest immune response observed in a subset of
and Seattle, WA - August 30, 2006
Targeted Genetics Corporation (Nasdaq: TGEN) announced that Nathan Clumeck,
PhD, Head of the Department of Infectious Diseases, St. Pierre University
Hospital in Brussels, Belgium, will present interim results today from a Phase
clinical trial of tgAAC09, an investigational HIV/AIDS vaccine candidate based
on recombinant adeno-associated virus vector serotype 2 (AAV2). The trials
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 in Amsterdam August
29 until September 1, 2006, in Amsterdam, Netherlands. A second clinical trial
ongoing in South Africa, Uganda and Zambia to evaluate a higher dose and to
systematically evaluate the utility and optimal timing of boost vaccination.
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
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
support our efforts to develop a vaccine that has the potential to impact the
global HIV/AIDS pandemic."
the Clinical Program
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
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
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
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.
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 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
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 subsequent reports on Form 10-Q. You should not rely
unduly on these forward-looking statements, which apply only as of the date
this release. We undertake no duty to publicly announce or report revisions
these statements as new information becomes available that may change our