technology Reports Additional Results From Phase 2a Study of CYT003 for the Treatment of Allergic Asthma --> According to a release, a post-hoc analysis of data published in the March issue of
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.
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.
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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
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 percent-85 percent 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.
Cytos is a public biopharmaceutical company focused on the development of targeted immuno-therapies.
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According to a release, a post-hoc analysis of data published in the March issue of