SEEK Announces Clinical Proof of Efficacy in HIV Vaccine Phase Ib/II Human Trial
By Seek, PRNESunday, July 17, 2011
LONDON, July 18, 2011 -
90%
Reduction in HIV Viral Load
Demonstrated Compared With Normal Disease Progression
SEEK, a privately owned biopharmaceutical company specializing
in immunology, announces today that it has completed a Phase Ib/II
clinical trial of its HIV-v vaccine which demonstrates a one
log (approx 90 percent) difference in viral count in HIV-infected
people compared with the placebo group, after just a single vaccine
injection.
Gregory Stoloff, CEO of SEEK, commented: “This is the first time
ever that an HIV vaccine has shown such a meaningful result in a
human clinical trial. The next step will be to progress this to
final human trials and determine the optimum dose and dosing regime
to further enhance the vaccine’s efficacy.”
The development of an effective vaccine against HIV has been
extremely difficult because the HIV virus constantly mutates.
However, SEEK’s HIV-v vaccine targets only the conserved
regions in the internal proteins of the HIV virus which remain
constant across all HIV strains. It is the first vaccine to
generate both strong T-cell and antibody responses to eliminate
HIV-infected cells and thus neutralise the HIV virus. These
unique features mean that the vaccine, while initially tested in an
early stage of the disease as a therapeutic, could also be
effective as a prophylactic, pending confirmation in a future
trial.
Commenting on the results, Marta Boffito, MD, PhD, from the St.
Stephen’s Aids Trust and the principal investigator in the trial,
said: “These are remarkable results which demonstrate
HIV-v‘s safety and immunogenicity and, for the
first time, a clinically relevant result, as seen in the one
log reduction in viral titres. HIV has long reached pandemic status
and, despite growing numbers on anti-retrovirals, we are in
desperate need of both a prophylactic and therapeutic vaccine. This
HIV-v vaccine definitely warrants further investigation in
both these areas.”
About the Phase Ib/II trial
The Phase Ib/II trial involved 55 HIV-positive volunteers across
the UK, assessing safety and tolerability, as well as the
effectiveness of the vaccine by monitoring blood viral load and
CD4+ T-cell count, an immune cell which is specifically infected
with HIV. The involvement of T and B cells of the immune system in
response to the vaccine was assessed by measuring Interferon Gamma
and IgG levels.
It was conducted at six centres in the UK:
- North Manchester General Hospital;
- Grahame Hayton Unit of the Royal London Hospital;
- Elton John Centre at the Royal Sussex County Hospital;
- Royal Hallamshire Hospital;
- St. Stephen’s Centre at the Chelsea and Westminster Hospital,
London; and - St. Thomas’ Hospital, London.
There were five patient groups in the trial: four vaccinated
with HIV-v vaccine and one placebo. The four vaccinated
groups were divided into low-dose with and without adjuvant and
then a higher-dose with and without adjuvant.
Please visit
further data.
Wilson Caparros Wanderley, Chief Scientific Officer of SEEK,
added: “The results demonstrate that after a single immunizationthe
HIV-v vaccine produces a very strong response from both the
antibody and T cell immune systems to the conserved regions only.
This is the first time that an antibody response was made to
a conserved internal protein that appears on the cell surface
during the life-cycle of the HIV virus.”
Since the vaccine is synthetically manufactured, it will be
inexpensive to produce and can be quickly manufactured in large
quantities, making it viable for cost-effective widespread
distribution in low-income countries.
SEEK will evaluate partnerships to undertake final human trials
during 2012/13. It is expected that these will be therapeutic Phase
III trials, which will recruit HIV-infected patients whose
viral-load levels will be monitored to determine the optimal dose
and dosing regime. All patients will then be switched to that dose
and dosing regime and will be followed for the remainder of the
trials. Due to the defined and easily-measurable end-points (such
as viral-load levels) the trials are expected to be short in
duration. If approved, the vaccine could be available to patients
in 3-5 years time.
These data are being released to coincide with the 6th IAS
Conference on HIV Pathogenesis, Treatment and Prevention (IAS
2011), the world’s largest open scientific conference on HIV/AIDS,
being held in Rome from 17-20 July 2011. Held every two
years, the IAS conference attracts about 5,000 delegates from all
over the world. It is a unique opportunity for the world’s leading
scientists, clinicians, public health experts and community leaders
to examine the latest developments in HIV-related research, and to
explore how scientific advances can inform the global response to
HIV/AIDS.
Notes to Editors
Background
The development of an effective vaccine against HIV has been
extremely difficult because the HIV virus constantly mutates,
changing the peptide sequences (”epitopes”) of the viral structural
proteins that it presents to the human immune system. This means
that conventional approaches to the development of vaccines cannot
be employed.
SEEK’s HIV-v vaccine has been designed to specifically
target only certain conserved regions of the viral proteins that
are not subject to regular mutation. The advantage of this approach
is that HIV-v only delivers those specific epitopes that are
important in the host’s immune response, whereas other vaccines
employ whole proteins that have multiple internal and external
epitopes and therefore can cause the immune system to direct its
response against the wrong targets. With HIV-v, the immune
system is primed to recognise and target only those regions within
HIV proteins that are highly conserved and hence present in all
recorded strains of this highly variable virus.
HIV-v Vaccine
SEEK’s HIV-v vaccine can be quickly, easily and
cost-effectively manufactured. The vaccine consists of a number of
peptide sequences from viral proteins. These peptides are made
synthetically, thus allowing for increased purity and more
controlled dosing of the vaccine compared with conventional
vaccines obtained from or delivered by genetically-modified
organisms.
HIV Background/Economics
Human Immunodeficiency virus (HIV) is the causative agent for
AIDS. Infection with this retrovirus causes a progressive failure
of the immune system making the host susceptible to opportunistic
infections and cancers.
Currently, there are more than 33 million people living with
HIV/AIDS worldwide, according to the World Health Organization, the
majority of them in sub-Saharan Africa. Since 1980 over 25 million
people have died as a result of HIV/AIDS. Only 6.5 million out of
an estimated 17million are eligible for anti-retroviral (ARV)
treatment. UNAIDS estimates that $22bn a year will be required by
2015 to ensure universal access to treatment care and support by
people living with HIV/AIDS.
If the therapeutic efficacy of this vaccine is confirmed in
further human studies, newly-diagnosed people infected with HIV may
benefit from immediate treatment rather than waiting until their
health deteriorates to the status required to qualify for expensive
anti-retroviral (ARV) treatment programmes. This would also
reduce the risk of transmission and. provide a cost-effective means
of achieving UNAIDS’ declared objective in their Treatment 2.0
policy for AIDS, by making HIV treatment affordable for low-income
countries, especially those hardest hit in sub-Saharan Africa.
SEEK is working with the Rush Foundation (
www.rushfoundation.org) to incorporate an access
agreement for low-income countries, particularly sub-Saharan
Africa, within any partnership arrangement.
About SEEK
Founded in 2004, SEEK (formerly known as PepTcell) is a
privately-owned and funded biopharmaceutical company specializing
in immunology, with headquarters in London, UK. Using a pioneering
scientific approach focused on its novel understanding of the
molecular-level interactions between peptide-based T-cells (immune
cells), SEEK aims to create breakthrough medicines that address
major diseases in order to radically improve human health.
SEEK’s strategy is to take promising molecules through the early
stages of discovery to late-stage human proof-of-principle and then
seek partners for the final stages of development and ultimately
commercialisation. SEEK’s current product development areas are
vaccines, inflammation/autoimmune diseases, transplantation
tolerance-induction, respiratory diseases, cancer and
diabetes/obesity. SEEK currently has HIV and Influenza vaccines in
clinical development, with Hepatitis B, Hepatitis C, Rotavirus and
Malaria at preclinical stages.
HIV and Flu viruses both constantly mutate thereby making
vaccines to all strains a challenge for vaccine development. The
Flu-v and HIV-v vaccines use the same technology
platform to generate the vaccine targets. The HIV-v vaccine results
follow on from the successful Phase II Universal Influenza
Flu-v human trials, which showed that people formed immunity
to the vaccine antigen and were protected from an influenza
challenge.
For further information about SEEK please visit
SEEK
Gregory Stoloff, Chief Executive Officer, Tel:
+44-(0)20-7153-6570
Dr Stuart Robinson, Head of Medical Affairs, Tel:
+44-(0)-7789-487042
M: Communications
Mary Clark/ Amber Bielecka, Tel: +44-(0)20-7920-2361
seek@mcomgroup.com
.
Tags: July 18, London, Seek, United Kingdom
