PDL BioPharma: enrollment complete in phase 3 study of terlipressin for cirrhosis-related kidney failure

By Angela McDaniels

Seattle, March 23 - PDL BioPharma Inc. said its partner, Orphan Therapeutics LLC, has completed enrollment ahead of schedule in the pivotal phase 3 clinical study of terlipressin for the treatment of type 1 hepatorenal syndrome, a life-threatening complication of liver cirrhosis characterized by rapidly progressive kidney failure.

This is the first randomized, double-blind, placebo-controlled clinical trial of terlipressin in hepatorenal syndrome in the United States, according to a company news release.

The study is evaluating the safety and the potential effect of terlipressin on kidney function and patient survival in patients with type 1 hepatorenal syndrome and has enrolled 112 patients at 30 centers in the United States and five centers outside of the United States.

PDL BioPharma said patients will continue to be monitored during a six-month follow-up period and results are anticipated for release later this year.

"With a median survival of less than two weeks, there is a clear unmet medical need for the treatment of type 1 hepatorenal syndrome," PDL Biopharma senior vice president and chief medical officer Steven Benner said in the release.

"This phase 3 study will determine if terlipressin may serve as a bridge to a liver transplant and may also alleviate the acute crisis of the disease in those who are ineligible for transplant."

Types 1 and 2 hepatorenal syndrome result in about 14,000 hospitalizations annually in the United States, the company said, and there are no drugs approved for the treatment of this syndrome in the United States.

The Food and Drug Administration has granted terlipressin fast track designation and orphan drug status for the treatment of type 1 hepatorenal syndrome.

Orphan Therapeutics is responsible for the development of terlipressin in this orphan indication, and PDL BioPharma holds the exclusive marketing, sales and distribution rights to potentially commercialize terlipressin in the United States and Canada.

PDL BioPharma is a biopharmaceutical company based in Freemont, Calf., that discovers, develops and commercializes therapies for severe or life-threatening illnesses.

Orphan Therapeutics is a privately held drug development company based in Lebanon, N.J.

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