Kuros Biosciences Ltd.

Legal Proceedings Report • Oct 15, 2009

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Corporate | 15 October 2009 17:55

Interim analysis of an ongoing phase II study with nicotine vaccine shows primary endpoint not achieved

Cytos Biotechnology AG / Research Update

15.10.2009

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DGAP - a company of EquityStory AG.
The issuer / publisher is solely responsible for the content of this announcement.

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Schlieren (Zurich), Switzerland, October 15, 2009 - Cytos Biotechnology Ltd
(SIX:CYTN) was informed today by Novartis that an interim analysis of a
Phase II study with the nicotine vaccine NIC002 showed that the primary
endpoint was not achieved. This endpoint was defined as a statistically
significant difference in continuous abstinence from smoking determined
from weeks 8 to 12 after start of treatment compared to placebo. The study,
which is ongoing, is a double blind, placebo-controlled, multi-centre study
to evaluate the efficacy, safety, tolerability and immunogenicity of
repeated administrations of 100 microgram NIC002 in 200 cigarette smokers
who are motivated to quit smoking. In this study the treatment was safe and
well tolerated but failed to induce sufficiently high antibody titers,
which may have led to the negative outcome. Novartis is continuing the
study in order to collect more long-term data on the efficacy and safety of
NIC002 and will decide on the next steps once the scheduled 12 month
duration of the clinical trial is completed and when all data have been
analyzed.

About NIC002
NIC002 is a therapeutic vaccine in development for the treatment of
nicotine addiction. Vaccination with NIC002 has been shown to induce
nicotine-specific antibodies that bind nicotine in the bloodstream. As the
complex of nicotine attached to an antibody is too large to cross the
blood-brain barrier, nicotine uptake into the brain and the subsequent
stimulation of nicotine-responsive nerve cells is believed to be reduced.
In this way, the reward-inducing and addiction-driving stimulus of nicotine
should be minimized and abstinence from smoking more easily achieved and
maintained. In a previous Cytos phase II clinical trial the vaccine has
promoted and sustained long-term abstinence from smoking in the subgroup of
smokers that achieved high antibody levels upon vaccination.

About nicotine addiction
Worldwide, there are 1.3 billion smokers and with 4.9 million
tobacco-related deaths per year, tobacco use is the leading cause of
preventable death in the world today (WHO; Facts about smoking and health,
2006). Smoking harms nearly every organ of the body, resulting in
life-threatening diseases like cancer, chronic obstructive pulmonary
disease (COPD), stroke, and circulation disease. Nicotine is a
plant-derived alkaloid and the principal addictive component of tobacco.
Upon inhalation of cigarette smoke, nicotine passes into the bloodstream
and, within seconds, crosses the blood-brain barrier to enter the brain
where it stimulates specific nerve cells. Stimulation of these nerve cells
leads to the release of messenger molecules, which give rise to an almost
immediate reward and feeling of pleasure. This sensory stimulus is critical
to the addictive properties of nicotine and causes a high relapse rate
after quitting attempts. Although nearly 75% of smokers in the U.S. report
that they want to stop smoking, less than 5% of those who make an attempt
are able to stay tobacco-free for 3 to 12 months (CDC, USA; Surgeon
General's Report, 2004).

Glossary
Antibody: class of blood proteins generated by the immune system to
neutralize foreign material such as bacteria, viruses or toxins (i.e.
antigens).
Blood-brain barrier: the blood-brain barrier is a physical barrier between
the blood vessels in the central nervous system, and the central nervous
system itself. The barrier stops many substances from traveling across it.
Double blind: a design commonly applied in clinical trials where neither
the doctor nor the patient knows whether placebo or the active drug is
being administered.
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.

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 86 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 'may', 'will', 'is believed to', 'should
be', 'designed', 'intend' 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

15.10.2009 financial News transmitted by DGAP

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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) SWX

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