Cadence Pharmaceuticals announces agreement with fda on increased enrolment in Phase III clinical trial of Omigard (TM)
- Category: Proteins and Peptides
- Published on Tuesday, 31 July 2007 04:00
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SAN DIEGO, CA, USA | July 30, 2007 | Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), announced today that the U.S. Food and Drug Administration (FDA) has agreed with the company’s plan to increase the number of patients to be enrolled in the ongoing Phase III clinical trial of its experimental product candidate, Omigard™ (omiganan pentahydrochloride 1% aqueous gel) from 1,250 to 1,850.
The company also announced that in June 2007 it completed enrollment of the original target of 1,250 patients in this clinical trial, which is known as the Central Line Infection Reduction Study, or CLIRS trial, two months ahead of schedule.
“We are pleased with the strong rate of enrollment in the CLIRS trial, which has allowed us to achieve our original goal two months early. Based upon the current enrollment rate, and the fact that we have continued to add new clinical trial sites, we anticipate that we will complete enrollment of our new goal, 1,850 patients, in the second quarter of 2008. If the results of this trial are positive, we expect to submit a new drug application, or NDA, for Omigard in the first half of 2009,” said Ted Schroeder, Cadence Pharmaceuticals’ President and Chief Executive Officer.
“Achieving our initial enrollment objective early supports our belief that there is a significant, unmet medical need for Omigard,” said Jim Breitmeyer, the company’s Executive Vice President and Chief Medical Officer. “We greatly appreciate the dedication and commitment of the clinicians and support staff at our clinical trial sites, and our internal project team, whose efforts have made this result possible.”
Cadence Pharmaceuticals expects that the expanded enrollment in the CLIRS trial and additional development expenditures associated with the Omigard™ program will increase the company’s total operating expenses for the full year 2007 from between $49 million and $53 million to between $57 million and $60 million, including an estimated $4 to $5 million in non-cash stockbased compensation expenses. Cadence also anticipates that cash, cash equivalents and investments held for sale at December 31, 2007 will be between $35 million and $38 million.
In April 2007, the company announced its intention to propose to the FDA an increase in enrollment in the CLIRS trial in order to maintain the statistical power of the study in light of a re-analysis of data from the initial Phase III clinical trial of Omigard. The re-analysis, which used a slightly different, stricter definition for local catheter site infections (LCSIs), indicated a statistically significant reduction of LCSIs of 42% in the Omigard treatment arm as compared to the povidone-iodine treatment arm (the previous analysis indicated an approximately 49% 2 reduction), and indicated that the LCSI rate in the control group was lower than previously believed.
About the Omigard Clinical Development Program
Cadence’s ongoing Phase III trial of Omigard for the prevention of LCSIs 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 LCSI in patients requiring central venous catheterization. The CLIRS trial, which is designed to recruit 1,850 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 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 July 2003, Cadence Pharmaceuticals’ 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.
In April 2007, the company announced its intention to propose to the FDA an increase in enrollment in the CLIRS trial in order to maintain the statistical power of the study in light of a re-analysis of data from the initial Phase III clinical trial of Omigard. The re-analysis of data from the initial Phase III clinical trial of Omigard, which used a slightly different, stricter definition for LCSIs, showed that LCSIs were observed in 6.1% of subjects treated with the povidone-iodine control compared to 3.5% in the subjects treated with Omigard. This represents a 41.9% decrease in LCSIs, statistically significant at p = 0.032. Because the target sample size for the CLIRS trial was based, in part, upon the LCSI rate and treatment effect from the initial study, the company decided that it would be prudent to add patients 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. Because the CLIRS trial is being conducted 3 under a Special Protocol Assessment (SPA) with the FDA, Cadence was required to obtain the FDA’s concurrence with the proposal to increase enrollment in this trial.
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.
Cadence cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding: the anticipated completion of the increased enrollment of patients in the ongoing Phase III clinical trial of Omigard; the related projected financial impact; and the potential for filing an NDA for Omigard and the timing of any filing. The inclusion of forwardlooking 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; potential delays in the completion of the trial; 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; the market potential for pain, fever, local catheter site infections and other target markets, and our 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. Cadence™ and Omigard™ are trademarks of Cadence Pharmaceuticals, Inc.
SOURCE: Cadence Pharmaceuticals, Inc