Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Dutch biotechnology company Crucell has decided to suspend further clinical development of Aerugen, its vaccine candidate for the prevention of an infection in cystic fibrosis, after the drug failed to demonstrate the expected efficacy in a phase III trial.
Subscribe to our email newsletter
Aerugen, which was being evaluated for its ability to prevent Pseudomonas aeruginosa infection in cystic fibrosis patients, did not live up to the efficacy results indicated in an earlier clinical study.
The placebo-controlled phase III trial involved 476 patients from 46 centers in four European countries. In the study, patients without P. aeruginosa colonization were vaccinated with Aerugen or a placebo vaccine.
Safety results of the phase III study were in line with previous findings and did not show any clinically relevant safety issue.
Crucell said that discontinuation of this clinical development program does not impact the company’s revenue forecast for 2006, nor its earlier stated goal to achieve cash break-even in 2007.