Corporate | 21 May 2010 07:00
Cytos Biotechnology AG / Research Update
21.05.2010 07:00
Dissemination of a Corporate News, transmitted by
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- All patient reported outcome measures were continuously and
significantly improved vs. placebo from week 6 onward to the end of the
study
- Lung function objectively assessed by spirometry (FEV1) was
continuously and significantly improved vs. placebo from week 6 onward
to the end of the study
Schlieren (Zurich), Switzerland, May 21, 2010 - Cytos Biotechnology Ltd
(SIX:CYTN) reported today top line results from a double-blind,
placebo-controlled, multicenter phase II study to assess clinical efficacy
of CYT003-QbG10 in persistent allergic asthma bronchiale. The study
enrolled 63 allergic asthma patients requiring long term treatment with
inhaled corticosteroids. Patients received 7 injections of 900 µg QbG10 or
placebo and were monitored over a period of 12 weeks.
During a run-in phase before start of treatment with QbG10 or placebo, the
patients were converted to and stabilized on a standardized corticosteroid
therapy with beclamethasone. Four weeks after starting treatment with QbG10
or placebo, the dose of corticosteroid was reduced by 50%. Then, when
possible, four weeks later it was further reduced to zero. Both arms of the
study followed this steroid reduction and there were no significant
differences in steroid use at any time point. During the entire 12 week
study period, daytime and nighttime asthma symptoms and use of a
standardized relief medication (sultanol spray, a short-acting beta 2
agonist) were recorded in electronic patient diaries. In addition, lung
function was assessed on each visit by spirometry which measures forced
expiratory volume in one second (FEV1).
All patient reported outcome parameters were significantly improved vs.
placebo during each week from week 6 onwards to the end of the study at
week 12 (ITT analysis, LOCF). At week 12, the average daytime and nighttime
asthma symptom score had increased (i.e. disease worsened) by +29% for the
placebo group, while it decreased (i.e. disease improved) by -33% for QbG10
treated subjects (p=0.01). Use of relief medication had increased on
average by +106% for the placebo group, while it remained stable for the
QbG10 group (-4%) (p=0.01). The average combined symptom and medication
score worsened by +71% for the placebo group, while it improved by -17% in
the QbG10 group (p=0.006). In summary, the withdrawal of corticosteroid as
expected led to a worsening of the disease for placebo. In contrast for
patients treated with QbG10 their condition improved. This improvement came
despite the fact the patients either no longer used or strongly reduced
their intake of corticosteroids.
A subgroup analysis of the patients who completely ceased inhaling
corticosteroids after week 8 (22 on QbG10, 21 on placebo) allows a
comparison of patient reported outcome after QbG10 treatment (i.e. during
week 9 to 12) with beclamethasone therapy at baseline (i.e. the two weeks
before QbG10 or placebo therapy were initiated). The substitution of
beclamethasone by QbG10 led in these patients to a reduction of asthma
symptoms by -37% (p=0.02), a reduction of sultanol intake by -30% (n.s.)
and a reduction of the combined symptom and medication score by -34%
(p=0.07). The corresponding values under placebo treatment were +6%, +58%,
and +33%. This analysis suggests that treatment with QbG10 may result in a
therapeutic effect that is as good, or even better than inhaled
corticosteroid therapy.
Objective lung function measurement by spirometry reflected the strong
improvement seen in the patient reported outcome parameters. Here, the
forced expiratory volume in one second (FEV1) was significantly improved
vs. placebo at each weekly measurement from week 6 onwards until the end of
the study at week 12 (ITT analyses, LOCF). At week 12, the FEV1 had
decreased for those on placebo by an average of 251 ml (-8.4%) while it
remained stable for those on QbG10 treatment (-18.5 ml, -0.6%) (p=0.01).
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 of suspected relationship with treatment that occurred
in more than one patient.
Dr. Wolfgang Renner, CEO of Cytos commented the study results: 'Asthma and
allergies contribute greatly to the growing burden of chronic diseases that
inflict our societies and have reached epidemic proportions worldwide;
principally as a result of increased industrialization and urban living.
Allergic asthma is a significant cause of morbidity and mortality, often
affecting individuals early in their lives. With QbG10, we are within reach
of a product with the potential to become the first causally acting and
disease modifying therapy for allergic diseases addressing important unmet
medical need.
QbG10 has shown to rapidly and strongly improve both objective and patient
reported outcome measures of disease. The extent to which this has been
achieved may position QbG10 as a new standard therapy for allergies and
asthma. Achievement of this outstanding clinical result in the major
disease area of asthma builds on our earlier success with this product
candidate in allergic rhinitis and provides compelling evidence that Cytos'
VLP platform can confer significant therapeutic benefit in chronic
illnesses burdening the world's population.'
Conference call today at 3.00 pm (CET)
Cytos Biotechnology will host a conference call and Q&A session today,
Friday, May 21, 2010 at 3.00 pm (CET) to discuss the study results.
To access the conference call, please dial the following numbers:
Europe +41 91 610 56 00
U.S. +1 866 291 41 66
U.K. +44 207 107 06 11
The conference call will also be accessible by webcast on the internet. You
may follow the call live or have it replayed later on demand. To access the
webcast and the presentation, please follow the link provided on the
company's home page www.cytos.com. The conference will be held in English
and the presentation slides will be available for download 30 minutes prior
to the conference.
About CYT003-QbG10
CYT003-QbG10 is an immunotherapeutic product in development for the
treatment of allergy and asthma. It is based on Cytos Biotechnology's
modified Immunodrug(TM) platform, which applies immunostimulatory DNA
sequences to induce targeted T cell responses. The immunotherapeutic
encompasses the virus-like particle Qb, which is filled with the
immunostimulatory DNA sequence G10 - a synthetically produced stretch of
DNA originally derived from bacteria. This DNA sequence is recognized by so
called toll-like receptors, an evolutionary ancient class of receptors that
detect microbial patterns and serve as the first line of defense of the
immune system. CYT003-QbG10 aims to alter the immunological milieu and the
allergic immune cell responses to ameliorate allergic diseases. In a
previous phase IIb study in 300 patients with allergic rhinoconjunctivitis,
QbG10 was safe, well tolerated and efficacious in lowering the combined
symptom and medication score as well as in improving quality of life with
rhinoconjunctivitis.
About allergic asthma bronchiale
Asthma bronchiale (usually referred to as asthma) is a chronic inflammatory
disorder of the airways that causes breathlessness, chest tightness,
coughing and wheezing in susceptible individuals. Allergic asthma is the
most common form of asthma affecting around 150 million people worldwide
(1). It is further the most common chronic disease among children. Allergic
asthma is triggered by inhaled allergens such as dust mite allergen, animal
dander or pollen. Currently, there are three general approaches being
pursued to relieve the clinical manifestations of allergic asthma:
avoidance of the allergen, symptomatic treatment to alleviate acute
consequences of allergen exposure or chronic consequences of inflammatory
processes, and conventional immunotherapy, also known as desensitization,
which is the only treatment available that has a disease-modifying
long-term effect. Conventional immunotherapy, however, is time-consuming
(3-5 years) and with up to 80 allergen injections also inconvenient for the
patient. In addition, there is a risk of serious side-effects in response
to allergen exposure, which can even include anaphylaxis.
Reference
(1) World Health Organization; Asthma - Key facts; Fact Sheet No. 307, May
2008, and Asthma and Allergy Foundation of America (AAFA), Asthma facts and
figures, www.aafa.org, 2008
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 81 full-time employees.
Cytos Biotechnology Ltd is listed on the SIX Swiss Exchange (SIX:CYTN).
Glossary
Allergen: a normally harmless substance that elicits a misdirected immune
response.
Anaphylaxis: an acute and potentially life-threatening reaction of the
immune system to specific stimuli (e.g. allergens). If untreated, it can
result in shock, respiratory and cardiac failure, and death.
Desensitization: certain form of immunotherapy used in allergy treatment.
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.
FEV1: a lung function test, which measures forced expiratory volume in one
second (FEV1).
Inflammatory: substance evoking inflammation.
Immunotherapy / immunotherapeutic: a therapy / a medication aimed at
activation of the immune system to modulate a certain disease process.
Immunostimulatory: able to stimulate the immune system.
ITT analysis: an intention to treat (ITT) analysis is an analysis based on
the initial treatment intent, not on the treatment eventually administered.
It includes all randomized patients and is intended to avoid various
misleading artifacts that can arise in intervention research.
LOCF: means 'last observation carried forward'. Missing values are replaced
by the last observed value of this variable. If a patient deviated from the
corticosteroid reduction paradigm, the last value measured under the
correctly followed ICS reduction scheme was carried forward.
Persistent: refers to a defined classification of asthma disease severity.
Patients in this foregoing study suffer daily from asthma symptoms if
untreated.
Phase II: a clinical trial that examines a new drug candidate's safety and
preliminary efficacy in the targeted population and involves approximately
50-300 people.
Placebo: dummy medical treatment.
QbG10: the Immunodrug(TM) Qb filled with the synthetically produced
immunostimulatory DNA sequence G10.
This foregoing press release may contain forward-looking statements that
include words or phrases such as 'expected', 'suggest', 'may', 'become',
'will', 'intended', 'designed' 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
21.05.2010 Ad hoc announcement, Financial News and Media Release distributed by DGAP.
Media archive at www.dgap-medientreff.de and www.dgap.de
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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
WKN: -
Listed: Freiverkehr in Berlin, München, Stuttgart; Open Market in
Frankfurt; Foreign Exchange(s) SIX
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