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."