Bionor Immuno Advances HIV Peptide-Based Therapeutic Immunization Program with Start of a Phase IIb Trial in U.S. and Europe
A new innovative therapeutic immunization designed to help
existing HIV and AIDS patients enjoy prolonged drug - and side effect
- free periods was announced today at the AIDS 2008 conference in
Mexico City
MEXICO CITY--(Business Wire)--
Bionor Immuno today announced that it has advanced its efforts to
develop the first HIV therapeutic immunization with the dosing of
patients in a global Phase 2b clinical trial of the company's lead
candidate (Vacc-4x). This randomized, double-blind, placebo-controlled
trial is being conducted in HIV infected patients with the potential
to offer an important drug free break in their current antiretroviral
therapy. The company anticipates that trial results will be available
by year end 2009.
"The commencement of this global Phase 2b study represents an
important milestone in the clinical development of our Vacc-4x
therapeutic peptide candidate," said Birger S0rensen, President and
CEO of Bionor Immuno. "In previous clinical studies, this peptide
therapeutic candidate has demonstrated promising results in T-cell
stimulation of the immune system in HIV patients. Bionor is excited to
provide a potential significant step forward for treatment
alternatives in the management of HIV disease."
Earlier observations of HIV patients showed that sustained immune
responses to the protein p24 in the HIV virus were associated with
delayed disease progression. Building on this observation, Vacc-4x is
comprised of 4 modified synthetic peptides, each of which correspond
to a conserved domain of the p24 protein. The modified peptides in
Vacc-4x are designed to amplify and extend immunity to this protein,
which could allow for extended drug free periods and may delay disease
progression.
Dr. Barry Peters, Head of the Academic Unit of HIV & STDs at the
Guys & St Thomas' site of Kings College London, is leading the
research in the UK and has 20 years of clinical experience of managing
people with HIV infection. He says: "A successful immunotherapeutic
HIV vaccine would give patients and doctors enormous advantages over
current treatments, both in developed and developing countries. Even
if this vaccine is not the final answer, it could help the march
towards a successful immunotherapeutic HIV vaccine."
Dr. Richard Pollard, Head of the Infectious Diseases Division at
The University of California, Davis Medical School, Sacramento,
California, says "this is the largest current therapeutic vaccine
trial in the world involving 345 patients. This trial will establish a
solid foundation for HIV immune therapies if we can maintain
immunogenicity during drug free periods.
About Vacc-4x Peptide Therapeutic Candidate
Vacc-4x has been tested in two clinical trials exposing the
vaccine to 11 and 38 HIV patients, respectively. In both studies the
vaccine was found to be safe and well tolerated. In the phase IIa
study comprising 38 patients, the primary objective was to measure
immune responses to Vacc-4x. Subjects were initially maintained stable
on ART (Antiretroviral Therapy) while treated over a period of 26
weeks with a series of Vacc-4x immunizations at a low dose (LD) or
high dose (HD). This immunization phase included also an ART-free
window during which endogenous antigen stimulation was allowed.
-- The majority of subjects experienced a pronounced therapeutic
effect allowing them to remain off ART following completion of
the study (Week 52). While being off ART the patients CD4+
cell counts remained high above the level they had before they
had ART commenced by their treating physician.
-- Due to this pronounced clinical response permission was
granted to follow the subjects until they resumed ART. The
median treatment interruption achieved for all subjects in the
Vacc-4x Phase IIa clinical study was 31 months. The duration
of treatment interruption was linked to immune responsiveness
to the peptides.
-- At a follow up 44 months after treatment interruption, 34% of
the patients were still not back on ART treatment. For the
full appreciation of these unique data it should be noted that
previous experience has shown that ART usually cannot be
interrupted for more than 3-4 months.
About Bionor Immuno
Bionor Immuno AS is an innovative biotech company developing
synthetic peptide vaccines that stimulate cell mediated immunity.
Previous efforts made to utilize T-cell stimulation for a vaccine have
been notoriously unsuccessful and this is also the reason why such
vaccines are not on the market today. Bionor Immuno carefully designs
synthetic (modified) peptides with improved efficacy and safety
profiles. Among the diseases targeted are chronic infections caused by
HIV, HCV (Hepatitis C), HPV (Human Papilloma Virus) and Influenza.
Bionor Immuno's platform technology is universally applicable makes it
possible to extend the range of projects to include also vaccines
targeting common cancer diseases. www.bionorimmuno.com.
Hayhurst Media
Richard Hayhurst, +44 208 487 3788
+44 7711 821527
Richard@hayhurstmedia.com
or
Bionor Immuno Inc.
Jeff Hackman, 301-571-9395
jhackman@bionorimmuno.com
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