CRUCELL SUSPENDS CLINICAL DEVELOPMENT OF AERUGEN

Crucell has decided to suspend further clinical development of Aerugen, its vaccine candidate for the prevention of P. seudomonas aeruginosa infection in cystic fibrosis patients.

The decision follows the results of a double-blind, randomized, placebo-controlled Phase III trial involving 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. The primary endpoint of the study was the prevention of colonization with one or more of the serotypes of P. aeruginosa in the candidate vaccine.

The results of the study failed to confirm the efficacy results indicated in earlier clinical study. Based on these results, the company has decided to suspend further clinical development of the vaccine.