Columbia Laboratories (CBRX) Said PROCHIEVE Study Suggest an Effect on Delaying Cervical Shortening

April 26, 2007 8:20 AM EDT

Columbia Laboratories, Inc. (NASDAQ: CBRX) announced that preliminary results from the ongoing data analysis of the recently-completed randomized, placebo-controlled, double-blind Phase III clinical trial of PROCHIEVE 8% (progesterone gel) for the prevention of preterm birth in women with a previous preterm birth earlier than 35 weeks gestation has revealed a possible effect of PROCHIEVE 8% in delaying cervical shortening.

A short cervix (equal to or less than 3.0 centimeters as measured by ultrasound in mid-pregnancy) is a known indicator of increased risk for preterm birth; as the rate of cervical shortening increases during pregnancy, the risk of a preterm birth increases.

Although an effect on cervical length was not the primary focus of this trial, per the study protocol cervical length measurements were performed on all women at baseline and at 28 weeks gestation. Data from the study show a delay in cervical shortening in patients treated with PROCHIEVE 8%, and suggest a correlation between the cervical length data, progesterone administration, and both a reduction in the likelihood of preterm birth and an improvement in infant outcomes.

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