SAN DIEGO, April 30 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. announced today that it intends to discuss with the U.S. Food and Drug Administration (FDA) a proposal to increase the number of patients to be enrolled in the ongoing Phase III clinical trial of its experimental product candidate, Omigard(TM) (omiganan pentahydrochloride 1% aqueous gel) for the prevention of local catheter site infections (LCSIs). This ongoing trial is known as the Central Line Infection Reduction Study, or CLIRS trial.
The plan to increase the number of patients in the CLIRS trial is intended to maintain the statistical power of the trial and was prompted by the company's planned re-analysis of data from the initial Phase III clinical trial of this product candidate. This extensive re-analysis is being performed as part of the standard procedure for analyzing data to prepare a final report of the study for a potential New Drug Application or other applications for marketing authorization. The re-analysis, which uses a slightly different, stricter definition of LCSI, indicates a statistically significant reduction of LCSIs of approximately 42% in the Omigard treatment arm as compared to the povidone-iodine treatment arm (the previous analysis indicated an approximately 49% reduction), as well as a reduction in the overall LCSI infection rate. The catheter colonization and catheter-related bloodstream infection results from the initial Phase III study were not impacted by the re-analysis.
Because the target sample size for the CLIRS trial is based, in part, upon the LCSI rate and treatment effect, the company now believes that adding patients is prudent in order to maintain the statistical power of the study. Additionally, improvements to hospital infection prevention practices since the CLIRS trial began may reduce catheter-related infection rates, further supporting an increase in the number of patients.
The CLIRS trial is being conducted under a Special Protocol Assessment (SPA) with the FDA, so Cadence must obtain the FDA's concurrence with the proposal to increase enrollment in this trial. The company intends to initiate discussions with the FDA immediately.
"We are taking these measures because we believe they will enhance the statistical power of this study and allow us a better opportunity to achieve a positive result in the CLIRS trial. Clearly, our efforts will be focused on accelerating enrollment in order to off-set as much as possible the longer duration of the trial," said Ted Schroeder, Cadence Pharmaceuticals' President and Chief Executive Officer. "After we have completed our discussions with the FDA, we expect to announce details regarding the number of patients to be added to the trial, the anticipated financial impact, and other potential implications on the Omigard development program. However, we currently anticipate that adding patients to the CLIRS trial will move the completion of enrollment in this study from the second half of 2007 to mid-2008."
Conference Call and Webcast Details
Cadence's management will host a conference call on Tuesday, May 1 at 8:30 am Eastern Time (5:30 am Pacific Time) to discuss today's announcement. Interested investors and others may participate in the conference call by dialing (800) 811-0667 (domestic), or (913) 981-4901 (international). A replay of the webcast and teleconference will be available approximately two hours after the call. To access the webcast, please log on to the company's website at www.cadencepharm.com at least 15 minutes prior to the call to ensure adequate time for any software downloads that may be required. The webcast will remain available on the company's website for fifteen days.
About the Omigard Clinical Development Program
Cadence's ongoing Phase III trial of Omigard for the prevention of LCSIs (known as the Central Line Infection Reduction Study, or CLIRS trial) is a multi-center, randomized, evaluation committee-blinded study in patients whose medical condition requires a central venous catheter (CVC). The primary efficacy endpoint of the clinical trial is to evaluate whether Omigard is superior to 10% povidone-iodine in the prevention of LCSI in patients requiring central venous catheterization. The CLIRS trial, which was designed to recruit 1,250 patients randomized to receive either Omigard or 10% povidone-iodine, began enrollment in August 2005 and is currently being conducted at centers in the United States and Europe. The CLIRS trial is designed to have 80% power to detect significance at the 0.05 level. The Omigard development program holds fast track status from the FDA.
In February 2003, Cadence's licensor for Omigard, Migenix, Inc. (then known as Micrologix, Inc.) and Astellas Pharma, Inc. (then known as Fujisawa Healthcare, Inc.), Migenix' former collaborator, completed a multi-center, randomized, evaluation committee-blinded Phase III trial that compared Omigard to 10% povidone-iodine in patients receiving CVCs, peripherally inserted central catheters, and/or arterial lines. The study was conducted in 1,407 patients in 27 centers in the United States. The primary efficacy endpoint was to evaluate the superiority of Omigard compared to 10% povidone-iodine for the prevention of catheter related bloodstream infections (CRBSIs). Secondary efficacy endpoints included evaluating the superiority of Omigard for the prevention of LCSI and catheter colonization. The initial Phase III clinical trial demonstrated statistically significant results for the two secondary endpoints of this trial but did not show statistical significance for the primary endpoint, the prevention of CRBSIs.
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 products in development, including IV APAP (acetaminophen for injection) for the treatment of acute pain and fever, and Omigard (omiganan pentahydrochloride 1% aqueous gel) for the prevention of catheter-related infections. For more information about Cadence's pipeline, visit www.cadencepharm.com.
Forward-Looking Statements
Cadence cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. 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 release due to the risks and uncertainties inherent in Cadence's business, including, without limitation: Cadence's ability to enroll sufficient patients to complete the pending Phase III clinical trial of Omigard; anticipated timing to obtain the FDA's concurrence to increase patient enrollment and ultimately complete the trial; the potential that FDA may not agree with the company's proposal to increase patient enrollment, or may apply a statistical penalty to the clinical trial; the results of the company's continuing re-analysis of the data provided by Migenix and its former collaborator concerning the earlier Phase III clinical trial of Omigard; the adequacy of the trial design for the pending Phase III clinical trial of Omigard to generate data that are deemed sufficient by regulatory authorities to support potential regulatory filings, including an NDA, for Omigard; the potential for Omigard, or the company's other product candidate, IV APAP, to receive regulatory approval for one or more indications on a timely basis or at all; unexpected adverse side effects or inadequate therapeutic efficacy of IV APAP or Omigard that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for IV APAP or Omigard, including the ability to finalize a commercial supply agreement for IV APAP finished drug product; the market potential for pain, fever, local catheter site infections and other target markets, and the company's ability to compete; Cadence's ability to raise sufficient capital; and other risks detailed in Cadence's prior press releases as well as in Cadence's 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 news 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.
Omigard(TM) is a trademark of Cadence Pharmaceuticals, Inc. Contacts: William R. LaRue Susan Neath SVP & Chief Financial Officer Media & Investor Relations Cadence Pharmaceuticals, Inc. Porter Novelli Life Sciences 858-436-1400 (619) 849-6007
Cadence Pharmaceuticals, Inc.CONTACT: William R. LaRue, SVP & Chief Financial Officer of CadencePharmaceuticals, Inc., +1-858-436-1400; or Susan Neath, Media & InvestorRelations of Porter Novelli Life Sciences, +1-619-849-6007, for CadencePharmaceuticals, Inc.
Web site: http://www.cadencepharm.com/
