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Phase III Trial of Progesterone for the Prevention of Preterm Birth in Women with a Previous Preterm Birth Earlier than 35 Weeks Does Not Meet Endpoints.


Management to Hold Investor Conference Call at 8:30 am ET Monday

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 its 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 progesterone 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 did not achieve any reduction in the incidence of preterm birth at week 32, the primary endpoint, or at weeks 28, 35 and 37, secondary endpoints of the study.

Of the 611 evaluable patients in this 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 clinical trial, 302 received placebo and 309 received PROCHIEVE([R]) 8% (progesterone gel). The mean gestational age at delivery was approximately 37 weeks in both the active and placebo groups following treatment, an improvement from a mean of 30 weeks in the previous preterm birth for both groups. Over 60 percent of evaluable patients had a previous preterm birth at or below 32 weeks gestation; prior studies of progestins Progestins
A female hormone, like progesterone, that acts on the inner lining of the uterus.

Mentioned in: Anabolic Steroid Use, Endometrial Cancer
 to prevent preterm birth were comprised mainly of patients with prior preterm births at 34 weeks or greater.

The incidence and profile of adverse events in patients receiving PROCHIEVE 8% was similar to placebo, which was as expected given the product's documented safety history.

The Company is conducting detailed analyses of the study data, and intends to report the results of this trial in more detail at appropriate scientific venues.

"These study results are extremely disappointing. Despite solid evidence in this and other studies that PROCHIEVE 8% effectively delivers progesterone to the uterus, there was no difference in the reduction of preterm birth incidence in patients with a previous preterm birth earlier than 35 weeks and treated with progesterone versus placebo at any endpoint," said Robert S. Mills, president and chief executive officer of Columbia Laboratories.

"Although disappointed by these results, we have managed our resources carefully so that Columbia is in a strong position to build our existing infertility business. With our December 2006 acquisition of the U.S. marketing rights to CRINONE([R]) progesterone gel, we are now able to address both of our key infertility audiences, the reproductive endocrinologists and the obstetricians and gynecologists, with the only progestin progestin /pro·ges·tin/ (-jes´tin) progestational agent.

pro·ges·tin
n.
1. A natural or synthetic progestational substance that mimics some or all of the actions of progesterone.
 FDA-approved for use in infertility and for use during the first trimester of pregnancy. We also intend to continue to leverage our bioadhesive drug delivery system for proprietary and third-party opportunities, including our Phase II lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a  candidate for the prevention and relief of dysmenorrhea dysmenorrhea

Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur.
," concluded Mills.

Conference Call

Management will host a conference call to discuss the study results on Monday, February 5, 2007 at 8:30 AM ET at (800) 565-5442 or (913) 312-1298 and online at www.cbrxir.com, under "Events."

The teleconference replay will be available two hours after completion of the call through Friday, February 9, 2007 at (888) 203-1112 or (719) 457-0820, passcode 8491341. The archived webcast will be available for one year on the Company's investor website, www.cbrxir.com, under "Events."

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 almost 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 reproductive 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; 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Article Type:Clinical report
Date:Feb 4, 2007
Words:949
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