SEATTLE, Feb. 7 /PRNewswire-FirstCall/ -- Targeted Genetics Corp.
(Nasdaq: TGEN), the not-for-profit International AIDS Vaccine Initiative
(IAVI), the Indian Council of Medical Research (ICMR) and National AIDS
Control Organization (NACO), and researchers at Columbus Children's Research
Institute (CCRI) and The Children's Hospital of Philadelphia (CHOP) today
announced the initiation of a Phase I trial in India of tgAAC09, an
investigational recombinant adeno-associated viral vector (rAAV)-based
HIV/AIDS vaccine candidate. The trial in India is part of a multi-country
Phase I clinical development program for tgAAC09 that is also underway in
Germany and Belgium.
"The initiation of this trial is part of our comprehensive strategy to
evaluate AAV-based HIV/AIDS vaccine candidates in a variety of settings," said
H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics.
"We believe that this vaccine approach can contribute to addressing the global
HIV/AIDS pandemic, and we are conducting studies that will help us to optimize
a vaccine candidate that is safe and immunogenic with regard to anti-HIV
immune responses. HIV/AIDS is a significant and growing health problem in
India, as it is in many other parts of the world, and we are pleased to be
collaborating with IAVI and the Indian Government in studying tgAAC09 in a
region where development of an effective vaccine is essential."
The Phase I clinical trial is a double-blind, placebo-controlled,
dose-escalating safety study that will also monitor immune responses to the
product candidate. The study in India is designed to enroll up to
30 volunteers who are HIV uninfected and in good general health. Each
volunteer will receive a single intramuscular injection into the upper arm.
Data from this study, in combination with data generated by the ongoing Phase
I trial in Europe will help to guide future development of this vaccine
candidate. Targeted Genetics expects to report data from the European trial
in the first half of 2005.
Preclinical studies of tgAAC09 demonstrate that the vaccine induces
anti-HIV T-cell and B-cell responses in animal models. Other promising areas
of development identified through preclinical studies include the potential to
"boost" the effect of the vaccine by administering two sequential doses and
the potential utility of vectors derived from AAV serotype 1. Additional
studies designed to evaluate these findings in the context of tgAAC09 product
development efforts are ongoing.
About Targeted Genetics
Targeted Genetics Corporation develops gene-based products for preventing
and treating acquired and inherited diseases. The Company has three clinical
product development programs, targeting cystic fibrosis, AIDS prophylaxis and
inflammatory arthritis. The Company also has a promising pipeline of product
candidates focused on hemophilia and cancer, and a broad platform of gene
delivery technologies for application in nucleic acid-based drug development.
For more information about Targeted Genetics, visit its website at
Contact: Stephanie Seiler, Ph.D. - 206-713-0124
IAVI (http://www.iavi.org) is a global not-for-profit organization working to
accelerate the development of a vaccine to prevent HIV infection and AIDS.
Founded in 1996 and operational in 23 countries, IAVI and its network of
collaborators research and develop vaccine candidates. IAVI also advocates for
a vaccine to be a global priority and works to assure that a future vaccine
will be accessible to all who need it. IAVI's financial and in-kind supporters
include the Bill & Melinda Gates, Rockefeller, Alfred P. Sloan and Starr
foundations; the governments of Canada, Denmark, Ireland, the Netherlands,
Norway, Sweden, the United Kingdom and the United States; multilateral
organizations including the European Union and the World Bank; corporations
such as BD (Becton, Dickinson & Co.), Continental Airlines and DHL; leading
AIDS charities such as Crusaid, Deutsche AIDS Stiftung, and the Until There's
A Cure Foundation; and other private donors such as the Phoebe W. Haas
Charitable Trust B.
Contact: Ellena Friedman - 212-847-1090
Columbus Children's Research Institute (CCRI; http://www.ccri.net) on the campus
of Columbus Children's Hospital discovers novel approaches to human diseases
through research that ranges from basic molecular biology to applied,
patient-oriented research. In 2002, the Institute conducted more than
500 research projects. CCRI ranks among the top 10 in National Institutes of
Health research awards to free-standing children's hospitals in the US. CCRI
is dedicated to enhancing the health of children and their families locally,
nationally and globally.
Contact: Pam Barber - 614-722-4595
The Children's Hospital of Philadelphia was founded in 1855 as the
nation's first pediatric hospital. Through its long-standing commitment to
providing exceptional patient care, training new generations of pediatric
healthcare professionals and pioneering major research initiatives, Children's
Hospital has fostered many discoveries that have benefited children worldwide.
Its pediatric research program is among the largest in the country, ranking
second in National Institutes of Health funding. In addition, its unique
family-centered care and public service programs have brought the 430-bed
hospital recognition as a leading advocate for children and adolescents. For
more information, visit http://www.chop.edu.
Contact: Peggy Flynn - 267-426-6080
Safe Harbor Statement under the Private Securities Litigation Reform Act
This release contains forward-looking statements regarding our research
programs, clinical trials, product development and potential related to
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, the timing, nature and results of our
research and our clinical trials, our preclinical results with animals are not
necessarily indicative of results that will be obtained in humans, our ability
to obtain and maintain regulatory or institutional approvals, our ability to
obtain, maintain and protect our intellectual property related to tgAA09, and
our ability to raise capital when needed, as well as other risk factors
described in the section entitled "Factors Affecting Our Operating Results,
Our Business and Our Stock Price" in our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2004. 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
SOURCE Targeted Genetics Corporation
Web Site: http://www.targetedgenetics.com