Cytos Provides Update of Phase 2b Clinical Trial of CYT003 in Allergic Asthma

Cytos Provides Update of Phase 2b Clinical Trial of CYT003 in Allergic Asthma

Guidance for top-line results in 1H 2014 reiterated

PR Newswire

SCHLIEREN, Switzerland, January 16, 2013

SCHLIEREN, Switzerland, January 16, 2013 /PRNewswire/ --

Cytos Biotechnology Ltd (SIX:CYTN) today announced an update on the Phase 2b
clinical trial with its lead product candidate, CYT003, in allergic asthma.
The clinical trial will recruit approximately 360 adult patients with moderate
to severe allergic asthma not sufficiently controlled on current standard
therapy. The study will be conducted at more than 90 centers in North America
and Europe, and is expected to read out top-line data in 1H 2014. Regulatory
approvals to conduct the trial have been obtained in various countries in
Europe and North America including the United States, where an IND
(Investigational New Drug) application has been approved by the US Food & Drug
Administration.

In the course of periodic drug quality measurements, a technical issue was
identified with the rubber stoppers used to close the injection vials
containing the clinical trial material. Cytos will replace this clinical trial
material and have new material available at clinical trial sites in Q2 2013.

Overall guidance for the clinical trial remains unchanged. Cytos expects to
have top-line data available in the course of 1H 2014 and full data towards
the end of 2014.

Christian Itin, Chairman and CEO of Cytos Biotechnology, comments: "We
appreciate the support of our investigators and are looking forward to
evaluating CYT003 in patients with allergic asthma."

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
first-in-class biologic in Phase 2 clinical development as a potential new
treatment for allergic asthma.

CYT003 acts via a novel, allergen-independent mechanism of action to
selectively suppress the body's immune response to allergens, a predominant
risk factor for asthma. In a successfully completed Phase 2a study, CYT003 was
shown to maintain asthma control and lung function and asthma control in
patients with persistent allergic asthma, even as standard inhaled
corticosteroid treatment was withdrawn. CYT003 has been shown to be safe in
over 450 patients to date.

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.

http://www.cytos.com

This foregoing press release may contain forward-looking statements that
include words or phrases such as"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.

SOURCE Cytos

Contact: 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
 
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