|
Cytos Biotechnology reports positive results from placebo controlled phase IIa study in patients suffering from house dust mite allergy |
|
|
|
16 May 2007 |
Cytos Biotechnology AG (SWX:CYTN) reported today positive results from a multi-centre and placebo-controlled phase IIa study with different formulations of CYT003-QbG10, an immunotherapeutic product candidate for the treatment of allergic diseases.
SCHLIEREN, Switzerland | May 15, 2007 | Cytos Biotechnology AG (SWX:CYTN) reported today positive results from a multi-centre and placebo-controlled phase IIa study with different formulations of CYT003-QbG10, an immunotherapeutic product candidate for the treatment of allergic diseases. The study included 40 patients suffering from mild to moderate allergic rhinitis due to house dust mite allergy and assessed in a double-blind setting the safety, tolerability and exploratory efficacy of CYT003-QbG10 monotherapy, CYT003-QbG10 combined with a low dose of house dust mite allergen extract (designated CYT005-AllQbG10), allergen extract alone and placebo. Exploratory efficacy was determined by evaluating the allergic disease status of the patients before and after treatment by the conjunctival provocation test.
Both formulations of CYT003-QbG10 tested were safe and well tolerated. The table below summarizes on the first results obtained two weeks after the last dose. A statistically significant increase in the median allergen tolerance against baseline was observed only in the two treatment arms which comprised QbG10 (i.e. CYT003-QbG10 monotherapy and CYT005-AllQbG10), whereas none of the intergroup comparisons achieved statistical significance.
For table reference see PDF document.
Dr. Wolfgang Renner, CEO of Cytos Biotechnology commented: “With each study we gain a deeper understanding of the activity of QbG10 in allergic diseases. If we look at the entire data set of the 80 allergic patients treated so far with QbG10 in the different studies, we can see the following picture: QbG10 seems to be active as a monotherapy; however, combination with an allergen extract at a standard dose appears to enhance the therapeutic effect. The highest efficacy was achieved when QbG10 was combined with a dose of allergen extract usually applied in conventional desensitization therapy, i.e. a 10-times higher dose than the one tested in this present study. In a next clinical trial we will test higher doses of CYT003-QbG10 monotherapy and compare the safety and efficacy profile directly with the most promising product formulations of CYT005-AllQbG10 in order to select the best product candidate for late stage development.”
CYT003-QbG10 Conference Call and Webcast Cytos Biotechnology will host a conference call and Q&A session today, Tuesday, May 15, 2007 at 10 am (CET) to discuss the study findings.
SOURCE: Cytos Biotechnology AG |
