Cytos Biotechnology Ltd (SWX:CYTN) announced
results from two randomized, double-blind, placebo-controlled,
multicentre phase II studies
with CYT003-QbG10 monotherapy for the treatment of house dust mite and cat
allergy, and with
CYT005-AllQbG10 combination therapy for the treatment of house dust mite
allergy. The studies were
conducted in order to determine whether QbG10 acts through an
allergen-independent or allergendependent
mechanism of action and to define the strategy for late-stage development of
this
product candidate.
Study 08 with CYT003-QbG10 monotherapy included 80 patients suffering from
house dust mite and /
or cat allergy and investigated the safety, tolerability and efficacy of six
injections of ascending
doses of CYT003-QbG10 (300-900?g) or placebo. Treatment with CYT003-QbG10
was safe, very well
tolerated and significantly reduced rhinoconjunctivitis symptoms in daily
life compared to placebo
(p=0.008). The CYT003-QbG10 treatment group mean total rhinoconjunctivitis
symptom score had
fallen from 9.3 points pre-treatment to 3.6 points post-treatment (-61%),
whereas for the placebo
group a reduction from 9.2 points pre-treatment to 6.3 points post-treatment
(-32%) was observed.
Also, the allergen tolerance as measured in the conjunctival provocation
test was improved after
CYT003-QbG10 treatment compared to placebo (borderline significant, p=0.06).
In study 04, which compared CYT005-AllQbG10 (i.e. the combination of 300?g
QbG10 with an
approved allergen extract) and the allergen extract alone in 93 patients
suffering from house dust
mite allergy, reductions of the mean total rhinoconjunctivitis symptom score
of -54% for CYT005-
AllQbG10 and -51% for the allergen extract were observed (not significant).
The conjunctival
provocation test showed a trend in favour of CYT005-AllQbG10 (p=0.11). The
total number of
suspected adverse events was similar in both treatment arms and was
attributed mainly to the
presence of the allergen extract (CYT005-AllQbG10: 219 events; approved
allergen extract alone: 209
events). In contrast to this, CYT003-QbG10 monotherapy in study 08 was much
better tolerated with
a total number of suspected adverse events of only 20 (placebo: 10).
Dr. Wolfgang Renner, CEO of Cytos Biotechnology commented: "The two studies
clearly answered our
primary question about the mechanism of action of QbG10. To our great
satisfaction it turned out
that QbG10 is active as a monotherapy and that addition of an allergen
extract is not necessary. On
the contrary, avoidance of allergen extracts dramatically improves
tolerability as we have seen in
study 08. A product with an allergen-independent mechanism of action has
major advantages over
current immunotherapy approaches, which are all based on allergen
components. By nature, allergen
extracts can cause severe side effects, which may lead to potentially
life-threatening conditions like
anaphylaxis. This is why these treatments are contraindicated in those
patients who would benefit most from them: People with severe allergies and
asthma. In addition, such treatments are usually
administered only by specially trained physicians.
In contrast to this, the almost placebo-like side effect profile of
CYT003-QbG10 monotherapy may
enable the use of this product in larger patient populations and by general
practitioners. Its
allergen-independent mechanism of action simplifies treatment, since a
single agent can be used for
the treatment of multiple allergies. Also, it may be possible to use this
product in people for whom
immunotherapy is currently contraindicated.
With these major advantages, CYT003-QbG10 has potential to rejuvenate the
mature allergic diseases
market, which is dominated by either purely symptomatic drugs like
antihistamines or corticosteroids
or by immunotherapy products containing allergen components. We are
therefore excited to
advance CYT003-QbG10 monotherapy as a first-in-class, disease-modifying
product candidate into
late-stage development. Start of phase IIb is planned already in the forth
quarter this year."
About CYT003-QbG10 / CYT005-AllQbG10
CYT003-QbG10 / CYT005-AllQbG10 are immunotherapeutic products in development
for the treatment
of allergy and asthma. Both are based on Cytos Biotechnology’s second
ImmunodrugT platform,
which applies immunostimulatory DNA sequences to induce targeted T cell
responses. The
immunotherapeutics encompass the virus-like particle Qb, which has been
filled with the
immunostimulatory DNA sequence G10 - a synthetically produced stretch of DNA
originally derived
from bacteria. The resulting entity QbG10 is designed as a disease-modifying
treatment and aims to
alter the immunological milieu and the allergic immune cell responses to
ameliorate disease
symptoms. CYT003-QbG10 represents QbG10 monotherapy, whereas CYT005-AllQbG10
consists of
QbG10 combined to an approved allergen extract of house dust mites. As
clinical observations of the
present as well as earlier studies indicate, CYT003-QbG10 monotherapy seems
to act by an allergenindependent
mechanism of action so that it has potential as a treatment for a broad
range of
different allergies.
About allergic diseases
Allergy as a whole is a multi-faceted disease and manifests itself
clinically in various allergic
disorders including allergic rhinoconjunctivitis, asthma, eczema and food
hypersensitivity. It is an
exaggerated reaction by the patient’s immune system to a normally harmless
substance such as
various environmental proteins present in pollen, dust mite faeces, or food.
Allergy is a very common
chronic disease, and its prevalence has increased dramatically within the
last few decades. Today,
more than 20% of the world population suffers from allergic diseases1, and
Europe alone has 80 million adult allergy sufferers2. House dust mites and
cats represent the two most important allergen
sources for perennial allergies.
There are three general approaches being pursued today to relieve the
symptoms of allergic diseases:
avoidance of the allergen whenever possible; prescription of medication that
targets disease
symptoms; and conventional immunotherapy, also known as desensitization.
Symptomatic
medication available only offers short-term amelioration of the disease. For
patients this may mean
chronic use of corticosteroids and antihistamines - often with multiple
daily doses. Conventional
immunotherapy, on the other hand, is very time-consuming (3-5 years) and,
with up to 80 allergen
injections, it is also inconvenient for the patient, so that only few
allergy sufferers take advantage of
this therapy. It is, however, the only curative treatment available for some
defined allergies and
reduces disease symptoms over a longer period of time. There remains
significant unmet medical
need for disease-modifying and convenient allergy treatments.
About Cytos Biotechnology
Cytos Biotechnology Ltd is a public Swiss biotechnology company that
specializes in the discovery, development
and commercialization of a new class of biopharmaceutical products - the
ImmunodrugsT. ImmunodrugsT are
intended for use in the treatment and prevention of common chronic diseases,
which afflict millions of people
worldwide. ImmunodrugsT are designed to instruct the patient’s immune system
to produce desired therapeutic
antibody or T cell responses that modulate chronic disease processes. Taking
advantage of the high flexibility of its
ImmunodrugT platform, Cytos Biotechnology has built a diversified pipeline
of different ImmunodrugT candidates
in various disease areas, of which 6 are currently in clinical development.
The ImmunodrugT candidates are
developed both in-house and together with Novartis and Pfizer Animal Health.
Founded in 1995 as a spin-off from
the Swiss Federal Institute of Technology (ETH) in Zurich, the company is
located in Schlieren (Zurich). Currently,
the company has 132 employees. Cytos Biotechnology Ltd has been listed on
the SWX Swiss Exchange (SWX:CYTN)
since October 2002.
References
1 World Health Organization; Prevention of Allergy and Allergic Asthma,
January 2002.
2 GAL2EN - Global Allergy and Asthma European Network, 2008.
Glossary
– Allergen: a normally harmless substance that elicits a misdirected immune
response.
– Allergen extract: a mixture of allergenic components from e.g. house dust
mites.
– Allergen tolerance: non-reactivity to a certain allergen or reactivity
only up to the level of a predefined symptom score.
– Anaphylaxis: an acute and potentially life-threatening reaction of the
immune system to specific stimuli. If untreated, it
can result in shock, respiratory and cardiac failure, and death.
– Conjunctival provocation test: a commonly used allergy test to monitor
the allergic disease status of an individual.
– Contraindicated: when a medical treatment is not advised for use.
– Buy generic cialis Combination therapy: see under monotherapy.
– Disease-modifying: in contrast to symptomatic treatment, a
disease-modifying treatment aims at addressing the cause of
disease and modifying the disease progression.
– Double-blind: a set-up often used in clinical trials where neither the
doctor nor the patients know if placebo or the active
drug is applied.
– Immunotherapy / immunotherapeutic: a therapy / a medication aimed at
activation of the immune system to modulate a
certain disease process.
– Monotherapy: treatment with one drug as opposed to combination therapy.
Here the term refers to treatment with QbG10
alone (i.e. CYT003-QbG10) in contrast to the regimen where QbG10 is combined
to allergen extract (i.e. CYT005-AllQbG10).
– Phase II / phase IIb: clinical trial that examines a new drug candidate’s
safety, tolerability and efficacy in a larger group of
patients.
– Placebo: dummy medical treatment.
– QbG10: Cytos Biotechnology’s ImmunodrugT Qb filled with the
immunostimulatory DNA sequence G10.
Rhinoconjunctivitis: combination of rhinitis (inflammation of the nasal
mucosa) and conjunctivitis (inflammation of the
eye).
– T cell: immune cell playing an important role in cell-mediated immunity.
One differentiates various subgroups such as
cytotoxic (killer) T cells and T helper (Th) cells.
Cytos Biotechnology Ltd
generic zithromax online buy | Buy lasix pills | Buy generic viagra