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Cytos Biotechnology Presents Additional Results From Phase 2a Study of CYT003 for the Treatment of Allergic Asthma | SYS-CON MEDIA
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Cytos Biotechnology Presents Additional Results From Phase 2a Study of CYT003 for the Treatment of Allergic Asthma
Patients with baseline blood eosinophil counts above 0.1 cells/nL respond to treatment with CYT003
BY PR NEWSWIRE SEPTEMBER 9, 2013 01:00 AM EDT AR TIC LE R ATING: R EADS:

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ZURICH, September 9, 201 3 /PRNewswire/ -Cy tos Biotechnology Ltd (SIX:CY TN) today announced additional results of the phase 2a clinical trial with CY T003, a first-in-class immune modulator in clinical dev elopment as a potential new treatment for allergic asthma. A post-hoc analy sis 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 analy sis looked at TH2 activ ation assessed by baseline blood eosinophil (bEos) count as predictiv e marker for a response to the treatment with CY T003 v ersus placebo. The patients from the Phase 2a study were stratified into the two subgroups based on the median bEos in the ov erall 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 analy sis suggest that the efficacy of CY T003 measured by asthma control, sy mptoms and medication use, bronchodilation and inflammation markers, is particularly ev ident in patients with allergic asthma in the higher bEos group. Patients treated with placebo ex perienced deterioration on all outcome measures, whereas patients treated with CY T003 remained controlled despite ICS withdrawal. In contrast all patients with low bEos remained controlled in spite of steroid withdrawl. This observ ation suggests that patients in the lower bEos group were not dependent on ICS therapy to achiev e adequate control of their asthma. Of particular note, the effect on asthma control and FEV 1 in CY T003- 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 ev idence supporting the anti-inflammatory effect of CY T003 and its potential clinical benefit in patients with allergic asthma. Prof. Ian Pav ord of the Department of Respiratory Medicine, Allergy and Thoracic Surgery , Glenfield Hospital, Leicester, UK, who conducted the posthoc analy sis stated: "With this analy sis, we identify a lev el 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 CY T003, further supporting the potential clinical benefit of CY T003 in allergic asthma patients." [1 ] Beeh et al. The nov el TLR-9 agonist QbG1 0 shows clinical efficacy in

toddys m w rote: @Codi: I think w e are having m uch m ore detailed convers ation on your blog. I think lot of the points are addres s ed there or on m y blog and I don't w ant to repeat thos e again and again. On the s elf ins talling s oftw are point by pcarlpatrick I hear you that this has been prom is e s ince the 70s but 10 years ago I had to ins tall Linux, then Java, then DB2 then WebSphere and now I can get all thos e + the LB and the FW configured w ith a click of a button. I pers onally lik e this better then s pending hours or days us ing the traditional approach. Aug. 8, 2013 12:53 AM EDT

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[1 ] Beeh et al. The nov el TLR-9 agonist QbG1 0 shows clinical efficacy in persistent allergic asthma. J Allergy Clin Immunol. 201 3 Mar;1 31 (3):86687 4).

Cytos Biotechnology Presents Additional Results From Phase 2a Study of CYT003 for the Treatment of Allergic Asthma | SYS-CON MEDIA

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[2] Pav ord et al. Effect of baseline eosinophil count on response to CY T003QbG1 0 in patients with persistent allergic asthma. [ERS abstract P31 56; Date: September 9, 201 3; Time: 1 4:45-1 6:35; Room 3.7 ; Session 31 1 ] Conference Call Cy tos Biotechnology AG will host a conference call to discuss the content of this press release on 1 7 September 201 3, at 9 a.m. EDT / 1 500 CET. The dial-in numbers are: +41 (0) 58 31 0 50 00 (Europe) +44 (0) 203 059 58 62 (UK) + 1 (1 ) 631 57 0 561 3 (USA) The presentation can be v iewed clinking at the following link: http://serv ices.choruscall.eu/links/cy tos_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 fiv e centers in Germany and recruited 63 patients who receiv ed 7 weekly to bi-weekly subcutaneous injections, with efficacy assessment during 1 2 weeks. ICS treatment was withdrawn in two steps from 1 00% to 50% to 0%. Clinical endpoints included asthma control determined by a v alidated questionnaire (ACQ), lung function objectiv ely assessed by spirometry (FEV 1 ), day and night-time asthma sy mptoms and use of relief medication. In addition inflammatory markers (ex haled nitric ox ide and eosinophils in the peripheral blood) were ev aluated. The study met all clinical endpoints. In patients treated with CY T003 their asthma control improv ed despite ICS withdrawal. In patients on placebo, the withdrawal of ICS, as ex pected, led to a worsening of the disease with a statistically significant and clinically important difference between treatment groups. Treatment with CY T003 was safe and generally well tolerated. About CY T 003 Cy tos' lead candidate CY T003 is a first-in-class immune modulator in clinical dev elopment as a potential new treatment for allergic asthma. CY T003 is currently being ev aluated in a global, randomized and placebo-controlled Phase 2b clinical trial as an add-on therapy in 360 patients with moderate to sev ere allergic asthma not sufficiently controlled on standard controller therapy . The study was initiated in Q4 201 2 and top-line results are ex pected in H1 201 4. Cy tos has completed a Phase 2a study demonstrating CY T003 maintains asthma control and lung function, despite standard inhaled corticosteroid withdrawal. Its attractiv e safety profile is further supported by a database of ov er 450 patients treated with CY T003 in prev ious studies. CY T003 acts v ia a nov el mechanism of action to selectiv ely suppress the body 's immune response to allergens, which is considered a predominant risk factor for asthma. About allergic asthm a Asthma is one of the most common chronic diseases, with an estimated 300 million indiv iduals affected worldwide. Its prev alence is increasing, especially among children, with an ex pected 400 million patients by 2025. Allergic asthma is the most common ty pe of asthma with 7 5%-85% patients testing positiv e for allergies. Asthma is a chronic inflammatory disorder of the airway s. Chronically inflamed airway s are hy per-responsiv e; they become obstructed and airflow is limited (by bronchoconstriction, mucus plugs, and increased inflammation) when airway s are ex posed to v arious risk factors. Common triggers include ex posure to allergens (e.g. house dust mites, animal fur, pollens and molds), smoke, chemical fumes, respiratory (v iral) infections, ex ercise, strong emotional ex pressions, chemical irritants, and drugs (such as aspirin and beta blockers). Sy mptoms include recurring episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. About Cytos Biotechnology Ltd
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Cytos Biotechnology Presents Additional Results From Phase 2a Study of CYT003 for the Treatment of Allergic Asthma | SYS-CON MEDIA

Cytos is a public biopharmaceutical company focused on the development of targeted immuno-therapies. The Company's lead product candidate CY T003 is a novel, first-in-class, immune modulator in Phase 2 clinical development as a potential new treatment for asthma. CY T003 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, CY T003 w as show n to maintain asthma control and lung function in patients w ith persistent allergic asthma despite w ithdraw al of standard therapy w ith inhaled corticosteroids. CY T003 has been show n to have a good safety and tolerability profile in more than 450 individuals receiving the active agent so far. Cytos w as founded in 1 995 as a spinoff from the Sw iss Federal Institute of Technology (ETH) in Zurich. It is located in Schlieren (Zurich), Sw itzerland. The Company is listed according to the Main Standard on the SIX Sw iss Exchange Ltd under the symbol CY TN. http://w w w .cytos.com This foregoing press release may contain forw ard-looking statements that include w ords or phrases such as "w ould", "can", "expect", "are intended for", "are designed to", or other similar expressions. These forw ard-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 w ill enter clinical trials, that clinical trial results w ill be predictive for future results, that therapeutic entities w ill be the subject of filings for regulatory approval, that any drug candidates w ill receive marketing approval from the U.S. Food and Drug Administration or equivalent regulatory authorities, or that drugs w ill be marketed successfully. Against the background of these uncertainties readers should not rely on forw ard-looking statements. The Company assumes no responsibility to update forw ard-looking statements or adapt them to future events or developments. SOURCE Cy tos Biotechnology Ltd Published September 9, 201 3 Reads 1 53 Copy right 201 3 SY S-CON Media, Inc. All Rights Reserv ed. Sy ndicated stories and blog feeds, all rights reserv ed by the author.

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