Who is eligible to enroll in the Phase 3 clinical trials of VX-770?
Vertex initiated a Phase 3 registration program in May 2009. This program, if successful, is designed to meet FDA requirements for potential approval of VX-770. The registration program is comprised of three different clinical trials. The first is a 48-week trial for patients age 12 years and older who carry a G551D mutation of CF. The second is a 48-week trial for patients ages 6 to 11 years who carry a G551D mutation of CF. The third trial is a 16-week study to evaluate for the first time patients age 12 years and older who are homozygous for the Delta F508 mutation of CF, the most common mutation in CF patients. Additional criteria for enrollment in these trials will be posted on www.clinicaltrials.gov.
