Cytos Biotechnology Presents Additional Results From Phase 2a Study of CYT003 for the Treatment of Allergic Asthma

ZURICH, September 9, 2013 /PRNewswire/ --

Cytos Biotechnology Ltd (SIX:CYTN) today announced additional results of the phase 2a clinical trial with CYT003, a first-in-class immune modulator in clinical development as a potential new treatment for allergic asthma. A post-hoc analysis of data published in the March issue of The Journal of Allergy and Clinical Immunology [1] are presented today at the European Respiratory Society Annual Congress in Barcelona [2].

The post-hoc analysis looked at TH2 activation assessed by baseline blood eosinophil (bEos) count as predictive marker for a response to the treatment with CYT003 versus placebo. The patients from the Phase 2a study were stratified into the two subgroups based on the median bEos in the overall study population: a lower bEos group was defined with peripheral eosinophils at ≤0.1 cells/nL and a higher bEos group was defined with peripheral eosinophils at >0.1 cells/nL.

The results of the post-hoc analysis suggest that the efficacy of CYT003 measured by asthma control, symptoms and medication use, bronchodilation and inflammation markers, is particularly evident in patients with allergic asthma in the higher bEos group. Patients treated with placebo experienced deterioration on all outcome measures, whereas patients treated with CYT003 remained controlled despite ICS withdrawal. In contrast all patients with low bEos remained controlled in spite of steroid withdrawl. This observation suggests that patients in the lower bEos group were not dependent on ICS therapy to achieve adequate control of their asthma. Of particular note, the effect on asthma control and FEV1 in CYT003- compared to placebo-treated patients was more pronounced in the higher bEoS patient subgroup than the reported outcome for the full study. These findings add to the evidence supporting the anti-inflammatory effect of CYT003 and its potential clinical benefit in patients with allergic asthma.

Prof. Ian Pavord of the Department of Respiratory Medicine, Allergy and Thoracic Surgery, Glenfield Hospital, Leicester, UK, who conducted the post-hoc analysis stated: "With this analysis, we identify a level of peripheral blood eosinophil cell counts that identifies the patients who are more dependent on ICS to maintain asthma control. These patients had a better response to CYT003, further supporting the potential clinical benefit of CYT003 in allergic asthma patients."

[1] Beeh et al. The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma. J Allergy Clin Immunol. 2013 Mar;131(3):866-874).

[2] Pavord et al. Effect of baseline eosinophil count on response to CYT003-QbG10 in patients with persistent allergic asthma. [ERS abstract P3156; Date: September 9, 2013; Time: 14:45-16:35; Room 3.7; Session 311]

Conference Call

Cytos Biotechnology AG will host a conference call to discuss the content of this press release on 17 September 2013, at 9 a.m. EDT / 1500 CET.

The dial-in numbers are:
+41 (0) 58 310 50 00 (Europe)
+44 (0) 203 059 58 62 (UK)
+ 1 (1) 631 570 5613 (USA)

The presentation can be viewed clinking at the following link:

http://services.choruscall.eu/links/cytos_presenter.html

About the P2a clinical study

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 novel, first-in-class, immune modulator in Phase 2 clinical development as a potential new treatment for asthma.

CYT003 has a novel mechanism of action that inhibits the immune response that causes asthma, and may therefore be beneficial for the control of asthma. In a successfully completed Phase 2a study, CYT003 was shown to maintain asthma control and lung function in patients with persistent allergic asthma despite withdrawal of standard therapy with inhaled corticosteroids. CYT003 has been shown to have a good safety and tolerability profile in more than 450 individuals receiving the active agent so far.

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 "would", "can", "expect", "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