Sep 18 2012
Immune Targeting Systems Limited ("ITS"), an emerging leader in the
development of vaccines that promote T-cell responses against viruses
and cancers, today announces compelling data from two Phase I clinical
trials of FlunisynTM, the Company's lead vaccine programme
which elicits potent immune responses against multiple strains of
influenza-A virus. ITS also announces the appointments of Dr. Benjamin
Chen, Executive Chairman and Dr. Kevin FitzGerald, Chief Operating
Officer, to support the Company as it moves towards commercialisation of
its products and technologies.
The first Phase I trial showed that FlunisynTM generated
statistically significant cell-mediated immune responses to the vaccine
and was safe and well tolerated in vaccinated groups compared to
placebo. The trial was a randomised, double-blind, placebo-controlled,
escalating dose study in 48 healthy adult volunteers.
The second trial was a randomised, double blind study to compare the
immunogenicity of FlunisynTM, alone or with an undisclosed
adjuvant, in 48 healthy adult volunteers. Both formulations generated
strong cell-mediated immunity but with the adjuvant formulation
generating enhanced responses.
From both trials, the T-cell responses induced by FlunisynTM
were able to recognise multiple strains of influenza A.
Dr. Campbell Bunce, ITS' Research Director, commented: "From these Phase
I data, we are extremely encouraged to see that FlunisynTM
induces strong, pan-strain, immune responses that have the potential to
protect the population against the severe and sometimes fatal symptoms
of influenza infection. Additionally, the magnitude of the immune
response that was induced by Flunisyn™ is unprecedented for a peptide
based approach, with or without the use of adjuvants."
Dr. Bunce continued: "ITS' T-cell vaccine platform allows the design of
vaccines with the potential to provide clinical benefits that are not
currently provided by other vaccine approaches. Especially important is
the evidence that FlunisynTM induces cell-mediated immune
responses across multiple influenza A strains. With the growing body of
evidence for a critical role of the cellular arm of the immune system in
influenza, this is a significant step forward towards the development of
a pan influenza vaccine that can effectively manage seasonal and
pandemic influenza infections."
Flunisyn™ vaccination stimulates the production of T-cells that
recognise and destroy influenza-infected cells. In contrast,
conventional influenza vaccines induce an antibody response against the
virus (a "humoral" response). T-cell vaccines offer many clinical
advantages over conventional vaccines, especially against rapidly
mutating viruses, because they can promote immune responses to parts of
the virus that do not change from one flu season to the next. Flunisyn™
is therefore applicable to multiple seasonal and pandemic influenza
strains. The most conserved parts of the influenza virus are located
within the internal regions of the virus particle that are not presented
to the humoral arm of the immune system. This is why conventional
vaccines, which only target the highly variable, external regions of the
virus, have to be newly produced to counter the threat from each
season's circulating strain. Conventional influenza vaccines have
several additional limitations, most notably, low efficacy in at-risk
populations including the elderly, chronically ill and young children;
FlunisynTM has been designed to address these limitations.
Flunisyn™ is therefore designed to address the key demands of main
regulatory and governing bodies such as the US Food & Drug
Administration (FDA), the European Medicines Agency (EMA), and World
Health Organization (WHO) which include: prophylactic protection against
multiple strains of both seasonal and pandemic influenza, effectiveness
for at-risk groups, amenability to repeated dosing, potential for
combined vaccination with traditional vaccines and inexpensive, large
scale manufacture and stockpiling potential for global population
coverage and management of pandemic outbreaks.
The Company today also announces changes to the management team. Carlton
Brown, co-founder of ITS, has stepped down as CEO in order to pursue
other ventures and the leadership of the Company will be augmented by
the appointments of Dr. Benjamin Chen and Dr. Kevin FitzGerald. Drs.
Chen and FitzGerald, two biotech veterans, bring substantial experience
in the commercial development of products and in the development and
growth of life sciences companies.
Source: Immune Targeting Systems Limited