The Journal of Allergy and Clinical Immunology Publishes Phase 2a Study Results With Cytos Biotechnology's CYT003 for the Treatment of Allergic Asthma

ZURICH, March 13, 2013 /PRNewswire/ --

Cytos Biotechnology Ltd (SIX:CYTN) today announced the publication of the results from its phase 2a clinical trial with CYT003-QbG10 (CYT003), a first-in-class immune modulator in clinical development as a potential new treatment for allergic asthma. The data are published in the March issue of The Journal of Allergy and Clinical Immunology (JACI) in the article entitled "The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma" by Kai-Michael Beeh, MD, et al. (J Allergy Clin Immunol. 2013 Mar;131(3):866-874).

The article was selected for comment by the JACI Editors ("The Editors' Choice") under the heading "Get the balance right - therapeutic immune modulation in patients with allergic asthma" (J Allergy Clin Immunol. 2013 Mar; 131 (3):683).

The published study is a randomized, double-blind, placebo-controlled trial in patients with persistent allergic asthma requiring long-term treatment with inhaled corticosteroids (ICS). The study took place at five centers in Germany and recruited 63 patients who received 7 weekly to bi-weekly subcutaneous injections, with efficacy assessment during 12 weeks. ICS treatment was withdrawn in two steps from 100% to 50% to 0%. Clinical endpoints included asthma control determined by a validated questionnaire (ACQ), lung function objectively assessed by spirometry (FEV1), day and night-time asthma symptoms and use of relief medication. In addition inflammatory markers (exhaled nitric oxide and eosinophils in the peripheral blood) were evaluated. The study met all clinical endpoints. In patients treated with CYT003 their asthma control improved despite ICS withdrawal. In patients on placebo, the withdrawal of ICS, as expected, led to a worsening of the disease with a statistically significant and clinically important difference between treatment groups. Treatment with CYT003 was safe and generally well tolerated.

About CYT003

Cytos' lead candidate CYT003 is a first-in-class immune modulator in clinical development as a potential new treatment for allergic asthma. CYT003 is currently being evaluated in a global, randomized and placebo-controlled Phase 2b clinical trial as an add-on therapy in 360 patients with moderate to severe allergic asthma not sufficiently controlled on standard controller therapy. The study was initiated in Q4 2012 and top-line results are expected in H1 2014.

Cytos has completed a Phase 2a study demonstrating CYT003 maintains asthma control and lung function, despite standard inhaled corticosteroid withdrawal. Its attractive safety profile is further supported by a database of over 450 patients treated with CYT003 in previous studies.

CYT003 acts via a novel mechanism of action to selectively suppress the body's immune response to allergens, which is considered a predominant risk factor for asthma.

About allergic asthma

Asthma is one of the most common chronic diseases, with an estimated 300 million individuals affected worldwide. Its prevalence is increasing, especially among children, with an expected 400 million patients by 2025. Allergic asthma is the most common type of asthma with 75%-85% patients testing positive for allergies.

Asthma is a chronic inflammatory disorder of the airways. Chronically inflamed airways are hyper-responsive; they become obstructed and airflow is limited (by bronchoconstriction, mucus plugs, and increased inflammation) when airways are exposed to various risk factors. Common triggers include exposure to allergens (e.g. house dust mites, animal fur, pollens and molds), smoke, chemical fumes, respiratory (viral) infections, exercise, strong emotional expressions, chemical irritants, and drugs (such as aspirin and beta blockers). Symptoms include recurring episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning.

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 Biotechnology Ltd