Antigenics Presents Positive, Top Line Data from Phase I Herpes Clinical Trial
27 Juillet 2010 - 01:00PM
Business Wire
Antigenics (NASDAQ: AGEN) announced positive results with
AG-707, an investigational therapeutic vaccine being developed to
treat herpes simplex virus-2 (HSV-2), the virus that causes genital
herpes, in infected patients. Developed by Antigenics, the vaccine
triggers a cellular immune response, stimulating both CD4+ and CD8+
T cells.
“I believe these data represent the first finding of their kind
in genital herpes treatments—showing a vaccine, AG-707, elicits
both CD4+ and CD8+ T-cell responses in humans,” said David Koelle,
M.D., study investigator and professor of Medicine, Laboratory
Medicine and Global Health Medicine, University of Washington. "We
are very encouraged by these results. Recent data suggest both of
these arms of immunity are needed for successful treatment of
genital herpes.”
Data will be presented at the International Herpes Workshop
annual meeting in Salt Lake City, Utah, on July 27 by study
investigator, Dr. Koelle. The full data will be submitted for
publication in a peer-reviewed journal.
“The obvious potential of AG-707 is in managing outbreaks and
disease transmission in patients with genital herpes,” added
Koelle. “Being able to impact and possibly decrease the spread of
genital herpes would be a huge step in stemming this epidemic.”
“These results represent proof of concept for our proprietary
off-the-shelf infectious disease platform. Based on our technology
of integrating heat shock proteins with antigenic peptides, we
could potentially create therapeutic vaccines for many infectious
diseases. Our next step is to engage a partner to advance the
clinical development of AG-707 in genital herpes and to pursue the
broader application of the platform technology,” added Garo Armen,
PhD, Antigenics chairman and CEO.
STUDY RESULTS
In this four-arm, phase 1 study, 35 HSV-2 seropositive patients
received AG-707+QS-21 Stimulon® adjuvant (Antigenics proprietary
saponin adjuvant), AG-707 alone, QS-21 alone, or placebo. Patients
received three treatments at two-week intervals. The vaccine was
well tolerated, with injection site pain as the most common
reported adverse event.
All patients who were evaluable for immune response and received
AG-707 with QS-21 showed a statistically significant CD4+ T cell
response (100%; 7/7) to HSV-2 antigens as detected by IFNγ Elispot,
and the majority of those patients demonstrated a CD8+ T cell
response (63%; 5/8).
This study is the first to demonstrate that heat shock proteins
complexed to viral antigens induce an antigen-specific T cell
response in humans.
ABOUT HERPES
According to the Centers for Disease Control, genital herpes
affects more than 60 million Americans—or 1 in 6 people between
ages 14 and 49—with an additional 1.5 million new cases each year.1
This disease normally results in 6 outbreaks per year, but in
severe cases more episodes may result.2 The psychosocial
consequences of genital herpes are quite significant, as 57 percent
of those infected indicated that herpes had interfered with their
sexual relationships, 50 percent felt it was difficult to live with
genital herpes, and 37 percent felt that herpes had ruined their
lives.3 Additionally, ongoing research indicates an increasing
resistance to currently available genital herpes treatments.
ABOUT AG-707
AG-707 is an off-the-shelf therapeutic vaccine for the treatment
of genital herpes, which is caused by the herpes simplex virus-2
(HSV-2). The vaccine is based on Antigenics' heat shock protein
(HSP) platform technology. Heat shock proteins (HSPs), also called
stress proteins, are found in all cells (normal cells, cancer cells
and infected cells) and recent research has demonstrated that HSPs
play an essential role in the presentation of pieces of proteins
(or peptides) on the cell surface to help the immune system
recognize diseased cells. While the initial focus of development
has been in HSV-2, the HSP technology platform can potentially be
utilized for off-the-shelf treatment of many types of infectious
diseases such as HPV, HIV, hepatitis, malaria and tuberculosis.
AG-707 consists of recombinant human heat shock protein-70
complexed with 32 distinct 35-mer synthetic peptides from the HSV-2
proteome. This broad spectrum of herpes antigens is intended to
allow for more accurate immune targeting and surveillance, reducing
the likelihood of immune escape. Further, the diversity of antigens
in AG-707 increases the chance of providing efficacy for a wide
segment of the patient population.
ABOUT QS-21
QS-21 is a vaccine adjuvant designed to strengthen the body's
immune response to a vaccine's antigen, thus making it more
effective. QS-21 has become a critical component in the development
of investigational preventive vaccine formulations across a wide
variety of infectious diseases, and appears to be essential for
several investigational therapeutic vaccines intended to treat
cancer and degenerative disorders. Currently, QS-21 is being
studied in clinical trials in approximately 15 vaccine indications,
of which several are in late-stage clinical trials by Antigenics'
licensees, including GlaxoSmithKline and Janssen Alzheimer
Immunotherapy, a wholly owned subsidiary of Johnson &
Johnson.
ABOUT ANTIGENICS
Antigenics (NASDAQ: AGEN) is a biotechnology company working to
develop treatments for cancers and infectious diseases. For more
information, please visit www.antigenics.com.
This press release contains forward-looking statements,
including statements regarding the potential of AG-707 and HSP
platform technologies to effectively generate immune responses and
potentially treat genital herpes and other infectious diseases.
These statements are subject to risks and uncertainties that could
cause actual results to differ materially from those projected in
these forward-looking statements. These risks and uncertainties
include, among others, that results of future trials of AG-707 in
HSV-2 may be unfavorable; even if the results from these trials are
positive, significant additional trials, the outcome of which are
uncertain, would be required before submitting an application for
marketing approval; decisions by physicians, patients, and
regulatory agencies; availability of funding and other resources;
and the factors described under the Risk Factors section of
Antigenics’ Form 10-Q as filed with the Securities and Exchange
Commission for the quarter ended March 31, 2010. Antigenics
cautions investors not to place considerable reliance on the
forward-looking statements contained in this press release. These
statements speak only as of the date of this document, and
Antigenics undertakes no obligation to update or revise the
statements. All forward- looking statements are expressly qualified
in their entirety by this cautionary statement. Antigenics’
business is subject to substantial risks and uncertainties,
including those identified above. When evaluating Antigenics’
business and securities, investors should give careful
consideration to these risks and uncertainties.
1 Genital Herpes - CDC Fact Sheet;
http://www.cdc.gov/std/herpes/stdfact-herpes.htm#common; accessed
July 19, 2010
2 Herpes Virus;
http://www.herpesonline.org/articles/herpes_virus.html; accessed
July 19, 2010
3 Quality of Life and Use of Health Care among People with
Genital Herpes in France, Taboulet F, Halioua B, Malkin J-E. Acta
Derm Venereol 1999; 79: 380±384;
http://adv.medicaljournals.se/files/pdf/79/5/380-384.pdf
Agenus (NASDAQ:AGEN)
Graphique Historique de l'Action
De Fév 2024 à Mar 2024
Agenus (NASDAQ:AGEN)
Graphique Historique de l'Action
De Mar 2023 à Mar 2024