Cytos Biotechnology AG

DGAP-News: Cytos Biotechnology Ltd (SIX:CYTN) today presents additional results from its Phase 2a study of CYT003 for the treatment of allergic asthma

EQS Group-News: Cytos Biotechnology AG / Key word(s): Research Update
Cytos Biotechnology Ltd (SIX:CYTN) today presents additional results
from its Phase 2a study of CYT003 for the treatment of allergic asthma

09.09.2013 / 07:00

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Cytos Biotechnology presents additional results from Phase 2a study of
CYT003 for the treatment of allergic asthma

Patients with baseline blood eosinophil counts above 0.1 cells/nL respond
to treatment with CYT003.

Schlieren (Zurich), Switzerland, September 9, 2013 - Cytos Biotechnology
Ltd (SIX:CYTN) today announced additional results of the phase 2a clinical
trial with CYT003, a first-in-class immune modulator in clinical
development as a potential new treatment for allergic asthma. A post-hoc
analysis of data published in the March issue of The Journal of Allergy and
Clinical Immunology [1] are presented today at the European Respiratory
Society Annual Congress in Barcelona [2].

The post-hoc analysis looked at TH2 activation assessed by baseline blood
eosinophil (bEos) count as predictive marker for a response to the
treatment with CYT003 versus placebo. The patients from the Phase 2a study
were stratified into the two subgroups based on the median bEos in the
overall study population: a lower bEos group was defined with peripheral
eosinophils at < =0.1 cells/nL and a higher bEos group was defined with
peripheral eosinophils at >0.1 cells/nL.

The results of the post-hoc analysis suggest that the efficacy of CYT003
measured by asthma control, symptoms and medication use, bronchodilation
and inflammation markers, is particularly evident in patients with allergic
asthma in the higher bEos group. Patients treated with placebo experienced
deterioration on all outcome measures, whereas patients treated with CYT003
remained controlled despite ICS withdrawal. In contrast all patients with
low bEos remained controlled in spite of steroid withdrawl. This
observation suggests that patients in the lower bEos group were not
dependent on ICS therapy to achieve adequate control of their asthma. Of
particular note, the effect on asthma control and FEV1 in CYT003- compared
to placebo-treated patients was more pronounced in the higher bEoS patient
subgroup than the reported outcome for the full study. These findings add
to the evidence supporting the anti-inflammatory effect of CYT003 and its
potential clinical benefit in patients with allergic asthma.

Prof. Ian Pavord of the Department of Respiratory Medicine, Allergy and
Thoracic Surgery, Glenfield Hospital, Leicester, UK, who conducted the
post-hoc analysis stated: 'With this analysis, we identify a level of
peripheral blood eosinophil cell counts that identifies the patients who
are more dependent on ICS to maintain asthma control. These patients had a
better response to CYT003, further supporting the potential clinical
benefit of CYT003 in allergic asthma patients.'

[1] Beeh et al. The novel TLR-9 agonist QbG10 shows clinical efficacy in
persistent allergic asthma. J Allergy Clin Immunol. 2013
Mar;131(3):866-874).

[2] Pavord et al. Effect of baseline eosinophil count on response to
CYT003-QbG10 in patients with persistent allergic asthma. [ERS abstract
P3156; Date: September 9, 2013; Time: 14:45-16:35; Room 3.7; Session 311]

Conference Call

Cytos Biotechnology AG will host a conference call to discuss the content
of this press release on 17 September 2013, at 9 a.m. EDT / 1500 CET.

The dial-in numbers are:
+41 (0) 58 310 50 00 (Europe)
+44 (0) 203 059 58 62 (UK)
+ 1 (1) 631 570 5613 (USA)

The presentation can be viewed clinking at the following link:

http://services.choruscall.eu/links/cytos_presenter.html

About the P2a clinical study

The published study is a randomized, double-blind, placebo-controlled trial
in patients with persistent allergic asthma requiring long-term treatment
with inhaled corticosteroids (ICS). The study took place at five centers in
Germany and recruited 63 patients who received 7 weekly to bi-weekly
subcutaneous injections, with efficacy assessment during 12 weeks. ICS
treatment was withdrawn in two steps from 100% to 50% to 0%. Clinical
endpoints included asthma control determined by a validated questionnaire
(ACQ), lung function objectively assessed by spirometry (FEV1), day and
night-time asthma symptoms and use of relief medication. In addition
inflammatory markers (exhaled nitric oxide and eosinophils in the
peripheral blood) were evaluated. The study met all clinical endpoints. In
patients treated with CYT003 their asthma control improved despite ICS
withdrawal. In patients on placebo, the withdrawal of ICS, as expected, led
to a worsening of the disease with a statistically significant and
clinically important difference between treatment groups. Treatment with
CYT003 was safe and generally well tolerated.
About CYT003

Cytos' lead candidate CYT003 is a first-in-class immune modulator in
clinical development as a potential new treatment for allergic asthma.
CYT003 is currently being evaluated in a global, randomized and
placebo-controlled Phase 2b clinical trial as an add-on therapy in 360
patients with moderate to severe allergic asthma not sufficiently
controlled on standard controller therapy. The study was initiated in Q4
2012 and top-line results are expected in H1 2014.

Cytos has completed a Phase 2a study demonstrating CYT003 maintains asthma
control and lung function, despite standard inhaled corticosteroid
withdrawal. Its attractive safety profile is further supported by a
database of over 450 patients treated with CYT003 in previous studies.

CYT003 acts via a novel mechanism of action to selectively suppress the
body's immune response to allergens, which is considered a predominant risk
factor for asthma.

About allergic asthma

Asthma is one of the most common chronic diseases, with an estimated 300
million individuals affected worldwide. Its prevalence is increasing,
especially among children, with an expected 400 million patients by 2025.
Allergic asthma is the most common type of asthma with 75%-85% patients
testing positive for allergies.

Asthma is a chronic inflammatory disorder of the airways. Chronically
inflamed airways are hyper-responsive; they become obstructed and airflow
is limited (by bronchoconstriction, mucus plugs, and increased
inflammation) when airways are exposed to various risk factors. Common
triggers include exposure to allergens (e.g. house dust mites, animal fur,
pollens and molds), smoke, chemical fumes, respiratory (viral) infections,
exercise, strong emotional expressions, chemical irritants, and drugs (such
as aspirin and beta blockers). Symptoms include recurring episodes of
wheezing, breathlessness, chest tightness, and coughing, particularly at
night or in the early morning.

For further information, please contact:

Cytos Biotechnology Ltd
Harry Welten
Chief Financial Officer
Tel: +41 44 733 46 46
e-mail: harry.welten@cytos.com

US Investor enquiries
Susan A. Noonan
Tel: +1 (212) 966 3650
e-mail: susan@sanoonan.com

About Cytos Biotechnology Ltd

Cytos is a public biopharmaceutical company focused on the development of
targeted immuno-therapies. The Company's lead product candidate CYT003 is a
novel, first-in-class, immune modulator in Phase 2 clinical development as
a potential new treatment for asthma.

CYT003 has a novel mechanism of action that inhibits the immune response
that causes asthma, and may therefore be beneficial for the control of
asthma. In a successfully completed Phase 2a study, CYT003 was shown to
maintain asthma control and lung function in patients with persistent
allergic asthma despite withdrawal of standard therapy with inhaled
corticosteroids. CYT003 has been shown to have a good safety and
tolerability profile in more than 450 individuals receiving the active
agent so far.

Cytos was founded in 1995 as a spinoff from the Swiss Federal Institute of
Technology (ETH) in Zurich. It is located in Schlieren (Zurich),
Switzerland. The Company is listed according to the Main Standard on the
SIX Swiss Exchange Ltd under the symbol CYTN.

www.cytos.com

This foregoing press release may contain forward-looking statements that
include words or phrases such as 'would', 'can', 'expect', 'are intended
for', 'are designed to', 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.


End of Corporate News

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Document: http://n.equitystory.com/c/fncls.ssp?u=PUKDUSLOPG

Document title: Cytos_Press_E_130909

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09.09.2013 This Corporate News was distributed by EQS Schweiz AG.
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The issuer is responsible for the contents of the release.

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


End of News    EQS Group News-Service
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