Phase II study of CYT003 (Cytos Biotechnology) for Allergic Asthma meets all end points

Results from a Phase IIa clinical trial with CYT003 (vaccine), from Cytos Biotechnology, show the Allergic Asthma treatment has met all its end points. The study is a randomized, double-blind, placebo-controlled trial in patients requiring long-term treatment with inhaled corticosteroids (ICS). The study 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 ICS treatment was withdrawn in two steps from 100% to 50% to 0%.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, lung function objectively assessed by spirometry (FEV1), day and night-time asthma symptoms and use of relief medication. In addition inflammatory markers 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. See: "The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma" Kai-Michael Beeh, MD, et al. J Allergy Clin Immunol. 2013 Mar;131(3):866-874).