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Regulatory Filings • Nov 5, 2010

News Details

Corporate | 5 November 2010 07:00

New clinical study started with the nicotine vaccine NIC002

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

05.11.2010 07:00

Publication of a media release

Schlieren (Zurich), Switzerland, November 5, 2010 - Cytos Biotechnology Ltd
(SIX: CYTN) has been informed by Novartis that Duke University in
collaboration with Wake Forest University has received IND approval from
the FDA to commence a new clinical study with the nicotine vaccine NIC002.
This is a phase II clinical pharmacokinetic / pharmacodynamic study
performed with 65 smokers that will assess how nicotine antibodies, induced
by vaccination, affect the pharmacokinetics of nicotine during cigarette
smoking. The study is being conducted in the United States with funding
from the National Institutes of Health (NIH).

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, which can help to achieve and maintain abstinence from
smoking. 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).

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 80 full-time equivalents.
Cytos Biotechnology Ltd is listed on the main segment at 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
Wagistrasse 25, Postfach
CH-8952 Schlieren (Zurich)
Tel. +41 44 733 47 03
Fax. +41 44 733 47 04
e-mail: wolfgang.renner@cytos.com
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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