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and asthma control in patients with persistent allergic asthma, even as standard inhaled corticosteroid treatment was withdrawn.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.
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.