SAN DIEGO, Sept. 15 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that it has revised the expected timing of its announcement of results for the CLIRS trial, the company's Phase III clinical trial of Omigard(TM) (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections.
Cadence is currently engaged in discussions with the U.S. Food and Drug Administration (FDA) regarding the statistical analysis plan for the CLIRS trial. These discussions, which are being conducted under a Special Protocol Assessment (SPA), must be completed prior to unblinding the data from the trial. As a result, Cadence has revised the expected timing of its announcement of results for the CLIRS trial from the fourth quarter of 2008 to the first quarter of 2009. If the trial is successful, Cadence continues to plan for submission of a New Drug Application (NDA) for Omigard in the second quarter of 2009.
About the CLIRS trial
The CLIRS trial, or Central Line Infection Reduction Study, is Cadence's confirmatory Phase III clinical trial of Omigard(TM) for the prevention of catheter-related infections. The CLIRS trial is a multi-center, randomized, evaluation committee-blinded study in patients whose medical condition requires a central venous catheter. The primary efficacy endpoint of the clinical trial is to evaluate whether Omigard is superior to 10% povidone-iodine in the prevention of local catheter-site infections. The CLIRS trial, which has completed enrollment of over 1,850 patients randomized to receive either Omigard or 10% povidone-iodine, is designed to have 80% power to detect significance at the 0.05 level. The CLIRS trial is being conducted under an SPA with the FDA, which has granted fast track status to the Omigard development program.
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting. The company currently has two Phase III product candidates in development, Acetavance(TM) (intravenous acetaminophen) for the treatment of acute pain and fever, and Omigard(TM) (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections. For more information about Cadence's pipeline, visit http://www.cadencepharm.com.
Statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "expected," "anticipated," "intended," "plans," "will," and similar expressions, are intended to identify forward-looking statements, and are based on Cadence's current beliefs and expectations. Forward-looking statements include statements regarding the timeframes in which the company anticipates announcing the results of the CLIRS trial and submitting an NDA for Omigard. The inclusion of forward-looking statements should not be regarded as a representation by Cadence that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the company's business, including, without limitation, the following: the CLIRS clinical trial may produce negative or inconclusive results, or may be inconsistent with previously conducted clinical trials; the FDA may not agree with changes in the statistical analysis plan for the CLIRS trial proposed by Cadence, or may require the company to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of an NDA for Omigard; the FDA may not agree with Cadence's interpretation of the outcomes of final analyses of data from the CLIRS trial; the performance of third parties on whom Cadence relies to conduct the CLIRS trial or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; clinical trial data for Omigard may demonstrate inadequate therapeutic efficacy, or the prevalence or severity of adverse side effects may be greater than anticipated; the company may experience delays in completing important pre-commercialization manufacturing development activities for Omigard, and may be required to perform additional pre-clinical or clinical testing prior to submitting, or obtaining approval of, an NDA for Omigard; the company may require substantial additional funding to complete the development programs for its product candidates, including Omigard, and, if approved, to successfully launch its product candidates, and it may not be able to raise sufficient capital when needed, or at all; and other risks detailed in Cadence's prior press releases as well as in Cadence's periodic public filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Cadence undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Cadence(TM), Acetavance(TM) and Omigard(TM) are trademarks of Cadence
Contacts: William R. LaRue
SVP & Chief Financial Officer
Cadence Pharmaceuticals, Inc.
Director, Investor Relations
Cadence Pharmaceuticals, Inc.
|SOURCE Cadence Pharmaceuticals, Inc.|
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