PDL says terlipressin fails phase 3 trial

By Elaine Rigoli

Tampa, Fla., Aug. 3 - PDL BioPharma, Inc. announced that a double-blind, placebo-controlled, phase 3 clinical study of terlipressin, a vasoactive peptide, did not meet its primary endpoint in the treatment of type 1 hepatorenal syndrome (HRS), a life-threatening complication of advanced liver disease characterized by rapidly progressive kidney failure.

In this study, the primary endpoint was treatment success, defined as the percentage of patients alive at day 14 who demonstrated reversal of type 1 HRS, based upon two measurements of serum creatinine levels less than or equal to 1.5 mg/dL without dialysis or recurrence of disease.

The data showed a positive trend toward treatment success but did not reach statistical significance, the company said in a news release.

PDL obtained U.S. commercial rights to terlipressin following its acquisition of ESP Pharma in March 2005. The original agreement between ESP Pharma and Orphan Therapeutics, which conducted the study, was established in June 2004.

"Although the primary endpoint showed only a trend towards improvement, I am encouraged by other results and look forward to reviewing the data with the Food and Drug Administration," Orphan Theraputics president Peter Teuber said the release.

PDL is a biopharmaceutical company with headquarters in Fremont, Calif.

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