Columbia Laboratories Reports Preliminary Findings from the Ongoing Data Analysis of the Phase III Clinical Study of PROCHIEVE 8% (progesterone gel) to Prevent Preterm Birth.Data Suggest an Effect on Delaying Cervical Shortening LIVINGSTON, N.J. -- Columbia Laboratories, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CBRX) today announced that preliminary results from the ongoing data analysis of the recently-completed randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , placebo-controlled, double-blind Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of PROCHIEVE([R]) 8% (progesterone progesterone (prōjĕs`tərōn'), female sex hormone that induces secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. gel) for the prevention of preterm preterm /pre·term/ (-term´) before completion of the full term; said of pregnancy or of an infant. pre·term adj. 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. "We are excited to share these unexpected findings, which may support the further development of PROCHIEVE 8% to prevent preterm birth in women with a short cervix. It is estimated that of the 4 million pregnancies each year in the United States, 10 to 30 percent of pregnant women have a cervical length of 2.5 to 3.0 centimeters, in mid-pregnancy. This includes many women with first-time pregnancies, the group that suffers the largest number of premature babies each year," said Robert S. Mills, president and chief executive officer of Columbia Laboratories. "We are planning to meet with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in the coming months to explore the potential clinical and regulatory path for PROCHIEVE 8% to prevent preterm birth in this patient population. We also aim to publish the data from the recently completed trial in a series of manuscripts later this year and in early 2008." About PROCHIEVE 8% PROCHIEVE([R]) 8% (progesterone gel) is FDA-approved for progesterone supplementation or replacement as part of Assisted Reproductive Technology Assisted reproductive technology (ART) is a general term referring to methods used to achieve pregnancy by artificial or partially artificial means. It is reproductive technology used in infertility treatment, which is the only application routinely used today of (ART) treatment for infertile women with progesterone deficiency and for the treatment of secondary amenorrhea. Several trials showing these benefits have been published. PROCHIEVE 8% is safe for use during pregnancy, and has been safely used by tens of thousands of women globally to help sustain pregnancy at the early stages for ten years. The most common side effects of PROCHIEVE 8% include breast enlargement, constipation, somnolence somnolence /som·no·lence/ (som´no-lens) drowsiness or sleepiness, particularly in excess. som·no·lence n. 1. A state of drowsiness; sleepiness. 2. , nausea, headache, and perineal perineal /peri·ne·al/ (-ne´al) pertaining to the perineum. Perineal The diamond-shaped region of the body between the pubic arch and the anus. pain. PROCHIEVE 8% is contraindicated in patients with active thrombophlebitis thrombophlebitis: see phlebitis. or thromboembolic thromboembolic pertaining to or emanating from thromboembolism. thromboembolic meningoencephalitis see hemophilosis. thromboembolic parasitism see thromboembolic colic. disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. For more information, please visit www.prochieve8.com. About Columbia Laboratories Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's healthcare and endocrinology products that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE([R]) 8% (progesterone gel) and PROCHIEVE([R]) 8% (progesterone gel) in the United States for progesterone supplementation as part of Assisted Reproductive Technology treatment for infertile women with progesterone deficiency, and PROCHIEVE 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company also markets STRIANT([R]) (testosterone buccal buc·cal adj. 1. Of, relating to, adjacent to, or in the direction of the cheek. 2. Of or relating to the mouth cavity. buccal system) for the treatment of hypogonadism Hypogonadism Definition Hypogonadism is the condition more prevalent in males in which the production of sex hormones and germ cells are inadequate. in men. For more information, please visit www.columbialabs.com. Safe Harbor Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: This press release contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, which statements are indicated by the words "will," "plan," "expect" and similar expressions. Such forward-looking statements are subject to certain risks and uncertainties; actual results may differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE[R] 8% (progesterone gel), PROCHIEVE[R] 8%(progesterone gel), PROCHIEVE 4% (progesterone gel), and STRIANT[R] (testosterone buccal tablet) in the U.S.; the timely and successful development of new products, including the clinical and regulatory path for possible development of PROCHIEVE 8% for the prevention of preterm birth; the timely and successful completion of clinical studies; the impact of competitive products and pricing; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to publicly update any forward-looking statements. CRINONE([R]), PROCHIEVE([R]) and STRIANT([R]) are registered trademarks of Columbia Laboratories, Inc. |
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