Columbia completes enrollment in PROCHIEVE 8% Phase III study to reduce preterm birth in short cervix women

Jun 8 2010

Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced it completed enrollment in the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study last week. This randomized, double-blind, placebo controlled Phase III clinical study is evaluating the safety and efficacy of PROCHIEVE^® 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy.

"We are pleased to have completed enrollment in this important clinical program," said Frank C. Condella, Jr., Columbia's president and chief executive officer. "All patients were enrolled at mid-pregnancy, so the last infant could be born as late as mid-November. We intend to report top line study results four to six weeks later. If data from the PREGNANT Study are positive, we expect to file an NDA for PROCHIEVE 8% in this new indication with the FDA in 2011."

The PREGNANT study enrolled 465 healthy pregnant women between the ages of 15 and 45 at more than 40 sites in 10 countries. Nearly half of the subjects were enrolled in the U.S. Subjects were randomly assigned to receive either PROCHIEVE 8% or placebo vaginal gel once daily until the earlier of 37 weeks gestation or delivery. The primary endpoint of this study is the reduction in the incidence of preterm birth at less than or equal to 32 6/7 weeks gestation vs. placebo. Secondary outcomes include improvements in infant outcomes, reductions in the frequency of neonatal morbidities, mortalities and admissions for preterm labor, and the reduction in the frequency of preterm birth at less than or equal to 27 6/7 and 34 6/7, and less than 36 6/7, weeks gestation. Previous studies have shown that administering progesterone to women with a short cervix at mid-pregnancy can delay delivery and reduce the number of neonatal intensive care unit ("NICU") admissions and the number of days in the NICU, indicators of neonatal morbidity.

One of every eight live born infants is born prematurely; short cervix is the single most important predictor of preterm birth. There are currently no products approved for the prevention of preterm birth.