Kuros Biosciences Ltd.

Legal Proceedings Report • Jun 11, 2009

News Details

Corporate | 11 June 2009 07:00

Cytos Biotechnology Ltd: Initiation of combined phase I/IIa study with a novel anti-interleukin-1 beta vaccine in patients with type II diabetes mellitus

Cytos Biotechnology AG / Research Update

Release of a Corporate News, transmitted by DGAP - a company of EquityStory
AG.
The issuer / publisher is solely responsible for the content of this announcement.

---

Schlieren (Zurich), Switzerland, June 11, 2009 - Cytos Biotechnology Ltd
(SIX:CYTN) announced today that it has initiated a combined phase I/IIa
clinical study with CYT013-IL1bQb in type II diabetes mellitus.
CYT013-IL1bQb is a novel therapeutic vaccine candidate targeting
interleukin 1 beta (IL-1 beta), an inflammatory cytokine which has been
implicated in the pathogenesis of type II diabetes.

The study is a two-stage, randomized, double-blind, placebo-controlled,
multicentre study designed to evaluate the safety, tolerability and
preliminary efficacy of CYT013-IL1bQb in patients with type II diabetes
mellitus. The phase I stage with up to 32 patients will evaluate ascending
dose regimens of CYT013-IL1bQb. Thereafter, the following phase IIa stage
is planned to include 90 patients and to compare a selected dose regimen of
CYT013-IL1bQb to placebo.

About CYT013-IL1bQb:
CYT013-IL1bQb is a therapeutic vaccine candidate in development for the
treatment of type II diabetes mellitus (also referred to as type II
diabetes). It consists of modified IL-1 beta molecules coupled to the
virus-like particle Qb. IL-1 beta is an inflammatory cytokine, which has
been implicated in the pathogenesis of type II diabetes through the
destruction of pancreatic islet cells that produce insulin (1). The vaccine
aims at inducing antibodies against IL-1 beta with the goal to decrease
inflammation and reduce disease progression. Early clinical studies by
independent groups have shown that blockade of IL-1 beta with a monoclonal
antibody and a receptor antagonist had beneficial treatment effects in type
II diabetes patients (1,2). The findings suggest that blockade of IL-1 beta
has potential to modify type II diabetes by preserving insulin producing
cells and not just control disease symptoms as common anti-diabetic drugs
do. CYT013-IL1bQb represents an active immunization approach expected to
induce a long-lasting effect over several months so that convenient dosing
schedules and only low amounts of vaccine (in the 100 microgram range per
injection) are foreseen for individual patients.

About type II diabetes mellitus:
Diabetes mellitus is a group of metabolic disorders that are characterized
by chronically elevated blood glucose (sugar) levels caused by a lack of
the hormone insulin or by an inability of the body's tissues to respond
properly to insulin. Type II diabetes represents the most common form of
diabetes (~90% of all cases) and is largely the result of excessive
overweight and physical inactivity. The disease has reached epidemic
proportions and more than 200 million people worldwide are affected (3).
The International Diabetes Federation estimated that in 2007, US$ 232
billion were spent worldwide to treat and prevent diabetes and its
complications and that the disease caused 3.8 million deaths worldwide (4).
Traditionally considered a disease of adults, type II diabetes is
increasingly diagnosed in children in parallel to rising obesity rates.
Health consequences of diabetes can be serious and include kidney failure,
diabetic retinopathy, and cardiovascular diseases such as stroke and heart
attack. Current medical interventions to control blood glucose levels
include increase of physical exercise and improvement of dietary habits,
intake of oral anti-diabetic drugs and insulin injections.

References:
1 New England Journal of Medicine, 2007, 356:1517. Interleukin-1-receptor
antagonist in type 2 diabetes mellitus.
2 Xoma, Press Release September 8, 2008.
3 International Diabetes Federation (IDF), Diabetes Atlas, 3rd Edition,
2006.
4 International Diabetes Federation (IDF), Diabetes Facts & Figures,
www.idf.org, accessed April 2009.

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 different
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 spin-off from the Swiss Federal
Institute of Technology (ETH) in Zurich, the company is located in
Schlieren (Zurich). Cytos Biotechnology Ltd is listed on the SIX Swiss
Exchange (SIX:CYTN).

Glossary:
Antibodies: class of blood proteins generated by the immune system to fight
foreign invaders such as bacteria or viruses. Can also be induced against
the body's own disease-associated molecules to modulate an ongoing disease
process.
Anti-diabetic drugs: drugs that either stimulate insulin secretion, enhance
glucose uptake of muscle and fat cells, or increase sensitivity of body
cells to insulin. All with the goal to reduce the glucose level in the
blood.
Cytokine: small natural protein released by body cells. Can have specific
effects on the interactions between cells and on the behaviour of cells.
Dose regimen: describes the dose and the schedule according to which a drug
is administered.
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.
Inflammatory: substance evoking inflammation.
Insulin: natural hormone made by pancreatic islet cells. It regulates blood
glucose levels.
Monoclonal antibody: antibody derived from a single clone of cells all of
which have identical antigen binding sites. Represents an important class
of biopharmaceuticals.
Pathogenesis: the development of a disease; includes the origin of the
disease and the events leading to that disease.
Phase I/IIa: clinical trial that examines a new drug candidate's safety,
tolerability and preliminary efficacy in a small number of patients.
Placebo: dummy medical treatment.
Randomized: random assignation of clinical trial participants to different
treatment groups.
Receptor antagonist: refers here to a biopharmaceutical that binds to the
interleukin-1 beta receptor and blocks the action of interleukin-1 beta.
Therapeutic vaccine: activates the immune system against disease-associated
molecules with the goal of interfering with or modulating an ongoing
disease process.
Type II diabetes: most common form of diabetes.

This foregoing press release may contain forward-looking statements that
include words or phrases such as 'evaluate', 'up to', 'planned', 'will',
'aim', 'with the goal', 'suggest', 'potential', 'expect', 'foreseen',
'intend', '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.

For further information please contact:
Claudine Blaser, PhD
Director Corporate Communications, Cytos Biotechnology Ltd
Phone: +41 44 733 47 20; Fax: +41 44 733 47 18
e-Mail: claudine.blaser@cytos.com; Website: www.cytos.com

11.06.2009 Financial News transmitted by DGAP

Language: English
Issuer: 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

End of News DGAP News-Service

---