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Environmental & Social Information • Sep 21, 2010

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Corporate | 21 September 2010 12:00

Cytos Biotechnology Presents Novel Toll-Like Receptor 9 Agonist CYT003-QbG10 for the Treatment of Allergic Asthma at the 2010 Annual Conference of the European Respiratory Society

Cytos Biotechnology AG / Key word(s): Research Update

21.09.2010 12:00

Publication of a media release

Barcelona, Spain and Schlieren (Zurich), Switzerland, September 21, 2010 -
Cytos Biotechnology Ltd (SIX:CYTN) announced today that clinical results
with CYT003-QbG10 for the treatment of allergic asthma were presented at
the 2010 Annual Conference of the European Respiratory Society in
Barcelona, Spain. CYT003-QbG10 is a novel Toll-like receptor 9 agonist in
development for the treatment of allergic asthma and allergic rhinitis. The
study, which was presented by principal investigator Dr. Kai-Michael Beeh,
insaf Respiratory Research Institute, was a randomized, placebo-controlled,
multicenter phase II clinical trial in 63 patients suffering from
persistent allergic asthma that required maintenance therapy with inhaled
corticosteroids (ICS) to achieve asthma control. During the study period of
12 weeks the inhaled corticosteroid was withdrawn in two steps (to 50%
after 4 weeks and 0% after 8 weeks) and the effect of treatment with QbG10
was compared against placebo.

The key findings of the study are:

• The fraction of patients whose allergic asthma was 'well controlled'
  (ACQ score = 0.75) increased from 42% under ICS therapy to 67% under
  QbG10 treatment despite corticosteroid withdrawal, while under placebo
  the fraction of 'well controlled' patients fell from 40% to 33%
  (p=0.008).

• Asthma symptoms decreased by 33% under QbG10 treatment despite
  corticosteroid withdrawal, while they increased by 29% under placebo
  treatment (p=0.01). Use of relief medication doubled in the placebo
  group, while it remained stable in the QbG10 group (p=0.01).

• Symptomatic improvement was further supported by significant
  improvement in lung function (FEV1) versus placebo (p=0.009).

• Anti-inflammatory effects of treatment were demonstrated by a
  significant reduction in blood inflammatory cells under QbG10 therapy
  versus placebo (p=0.043).

Commenting on the study results Dr. Kai-Michael Beeh said: 'Achieving
asthma control is an important therapeutic goal. Despite current treatment
options, many patients unfortunately remain symptomatic. The proposed
disease modifier CYT003-QbG10 aims at eliminating the cause of allergic
asthmatic inflammation and should provide patients with a therapeutic
alternative to either replace or complement commonly used asthma
medications, e.g. inhaled corticosteroids, while maintaining or improving
asthma control. While more studies are needed to confirm our findings,
these study results are extremely encouraging as we have seen a strong and
consistent treatment effect compatible with an anti-inflammatory mode of
action that may turn out to become a disease-modifying treatment option for
asthmatic patients and potentially other T helper 2-mediated diseases.'

About the phase II study

The study was a randomized, placebo-controlled, multicenter phase II
clinical trial with 63 patients suffering from persistent allergic asthma
that required maintenance therapy with inhaled corticosteroids (ICS) to
achieve asthma control. Before initiation of CYT003-QbG10 or placebo
treatment (7 weekly to biweekly subcutaneous injections) patients were
converted to and maintained on a standardized inhaled corticosteroid
therapy as anti-inflammatory treatment (beclomethasone) and the
short-acting beta 2 agonist salbutamol as relief medication.

Patients where then randomized to treatment with either CYT003-QbG10 or
placebo as add-on treatment for 4 weeks. At week 4, patients entered a
corticosteroid reduction phase, where the ICS dose was initially reduced by
50% for the following 4 weeks and completely withdrawn at week 8 if the
patients' clinical stability allowed. Patients were closely monitored until
week 12. During the 12-week study period, asthma control (ACQ),
patient-reported outcomes (daytime and night-time symptoms, use of relief
medication), lung function (FEV1), blood eosinophils and exhaled nitric
oxide (eNO) were measured.

Asthma control was determined by a validated Asthma Control Questionnaire
which rated seven items related to life with asthma. Under CYT003-QbG10
treatment the fraction of patients whose asthma was 'well controlled' (ACQ
score = 0.75) increased from 42% pre-treatment to 67% post-treatment
despite corticosteroid withdrawal, while on placebo this fraction decreased
from 40% to 33% (p=0.008). At week 12, the mean ACQ score was 1.49 in the
placebo group where it approached the threshold for loss of asthma control
(ACQ score = 1.5). In the QbG10 group the mean ACQ score was 0.77 and
therefore close to the threshold of the definition for good asthma control
(ACQ score = 0.75) (p=0.005). Under stable ICS therapy before initiation of
QbG10 or placebo, the mean ACQ score was 0.88.

Daytime and night-time asthma symptoms were recorded in electronic diaries
throughout the study period of 12 weeks. Under CYT003-QbG10 treatment,
both, daytime and night-time asthma symptoms decreased, while they
increased under placebo (p=0.003). At week 12, asthma symptoms had
decreased by 33% under QbG10 treatment, while they had increased by 29%
under placebo (p=0.01). Use of relief medication doubled (+106%) in the
placebo group, while it remained stable in the QbG10 group (-4%) (p=0.01).
The corresponding combined symptom and medication score improved by 17% in
the QbG10 group while it worsened by 71% for the placebo group (p=0.006),
with a first significant difference seen already in the second week after
the start of treatment.

Lung function was objectively assessed by spirometry at each visit.
Significant improvements in forced expiratory volume in one second (FEV1)
vs. placebo have been observed from week 6 onwards until the end of the
study. At week 12, the FEV1 had decreased on placebo by an average of 251
ml (-8.4%) while it remained stable on QbG10 treatment (-18.5 ml, -0.6%)
(p=0.01).

Finally, anti-inflammatory effects of treatment were demonstrated by a
significant reduction in blood eosinophils under QbG10 therapy versus
placebo (p=0.043) and a trend towards reduced exhaled nitric oxide levels
in treated patients. Treatment was safe and well tolerated. Local injection
site reactions of mostly mild to moderate intensity and two instances of
headache were the only adverse events that were suspected to be associated
with treatment and occurred in more than one patient.

About Asthma

Asthma is a chronic inflammatory disorder of the airways that causes
breathlessness, chest tightness, coughing and wheezing. Allergic asthma is
the most common form of asthma and its prevalence has grown dramatically in
the past century. An underlying reason for the rapidly increasing frequency
of asthmatic individuals in modern societies may be reduced exposure to
environmental pathogens; an idea summarized under the umbrella of the
hygiene hypothesis. A lack of infection with bacteria and viruses may skew
the immune system towards a so-called T helper type 2 response leading to
allergic diseases including asthma, allergic rhinitis and atopic
dermatitis.

About CYT003-QbG10

CYT003-QbG10 for the treatment of allergic asthma aims at stimulating a
crucial part of the human immune system via Toll-like receptor 9. Toll-like
receptors (TLRs) are a key set of immune system sensors that recognize the
presence of bacterial and viral infections. Toll-like receptor 9 binds
bacterial DNA originating from an infection and prepares the immune system
for a counterattack, inducing a normal anti-microbial T helper type 1
immune response and suppressing type 2 responses that lead to asthma and
allergies.

The novel product candidate CYT003-QbG10 developed by Cytos Biotechnology
consists of a synthetic stretch of DNA derived from mycobacteria, which is
packaged into the virus-like particle Q-beta for delivery. The resulting
product candidate CYT003-QbG10 therefore aims at treating the cause of
allergic asthmatic inflammation and should provide patients with a novel
therapeutic alternative that could either replace or complement commonly
used asthma medications, e.g. inhaled corticosteroids, while maintaining or
improving asthma control.

In previous studies CYT003-QbG10 has been shown to be safe and efficacious
for the treatment of allergic rhinitis. In a phase IIb study with 299
patients suffering from house dust mite allergy, a significant reduction in
the average combined symptom and medication score, the primary endpoint of
the study and the standard clinical parameter for the assessment of
allergic disease severity, was observed. Furthermore, treatment with
CYT003-QbG10 has led to a significant improvement in quality of life, as
determined by a validated quality of life questionnaire and a significant
improvement in allergen tolerance, as determined by a conjunctival
provocation test.

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 Immunodrugs(TM). Immunodrugs(TM)
are intended for use in the treatment and prevention of common chronic
diseases, which afflict millions of people worldwide. Immunodrugs(TM) 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 Immunodrug(TM)
platform, Cytos Biotechnology has built a diversified pipeline of
Immunodrug(TM) candidates in various disease areas, of which six are
currently in clinical development. The Immunodrug(TM) candidates are
developed both in-house and together with Novartis, Pfizer and Pfizer
Animal Health. Founded in 1995 as a spinoff from the Swiss Federal
Institute of Technology (ETH) in Zurich, the Company is located in
Schlieren (Zurich). Currently, the Company has 78 full-time employees.
Cytos Biotechnology Ltd is listed on the SIX Swiss Exchange (SIX:CYTN).

This foregoing press release may contain forward-looking statements that
include words or phrases such as 'are expected to', 'are intended for',
'are designed to', 'aims', 'should', 'may' or other similar expressions.
These forward-looking statements are subject to a variety of significant
uncertainties, including scientific, business, economic and financial
factors, and therefore actual results may differ significantly from those
presented. There can be no assurance that any further therapeutic entities
will enter clinical trials, that clinical trial results will be predictive
for future results, that therapeutic entities will be the subject of
filings for regulatory approval, that any drug candidates will receive
marketing approval from the U.S. Food and Drug Administration or equivalent
regulatory authorities, or that drugs will be marketed successfully.
Against the background of these uncertainties readers should not rely on
forward-looking statements. The company assumes no responsibility to update
forward-looking statements or adapt them to future events or developments.
This document does not constitute an offer or invitation to subscribe or
purchase any securities of Cytos Biotechnology Ltd.

Wolfgang A. Renner, PhD
Chief Executive Officer
Cytos Biotechnology Ltd
Phone: +41 44 733 47 03
Fax: +41 44 733 47 04
e-Mail: wolfgang.renner@cytos.com
Website: www.cytos.com

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Language: English
Company: Cytos Biotechnology AG
Wagistr. 25
8952 Schlieren
Schweiz
Phone: +41 44 733 4747
Fax: +41 44 733 4740
E-mail: info@cytos.com
Internet: www.cytos.com
ISIN: CH0011025217, CH0029060735
Swiss Security Number: -
Listed: Freiverkehr in München, Berlin, Stuttgart; Open
Market in Frankfurt; Foreign Exchange(s) SIX

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