- U.S. Pivotal Trial Evaluates Treatment for Life-Threatening Complication of
Liver Cirrhosis -
FREMONT, Calif., March 23 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc.
(PDL) (Nasdaq: PDLI) today announced that its partner, Orphan Therapeutics
LLC, has completed enrollment in the pivotal Phase 3 clinical research study
of terlipressin for the treatment of type 1 hepatorenal syndrome (HRS), 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 HRS in the United States
and the largest clinical trial ever conducted in HRS.
The study, which is evaluating the safety and the potential effect of
terlipressin on kidney function and patient survival in patients with type 1
HRS, has enrolled 112 patients at 30 liver disease centers in the United
States and five centers outside the United States. Patients will continue to
be followed during the six-month follow-up period. Results from this study
are anticipated for release later this year.
Steven Benner, M.D., Senior Vice President and Chief Medical Officer, PDL,
said, "With a median survival of less than two weeks, there is a clear unmet
medical need for the treatment of type 1 HRS, and innovative therapies are
needed. 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. We look forward to the
study results later this year."
Arun Sanyal, M.D., principal investigator of the study and Chairman,
Division of Gastroenterology, Hepatology and Nutrition and Professor of
Internal Medicine, Pharmacology, Pathology at Virginia Commonwealth
University, said, "Reaching our enrollment goal ahead of schedule is a major
clinical milestone in the development of terlipressin in the United States,
and we are hopeful that, ultimately, this therapy will be able to improve
outcomes for patients with this dire condition for which there are no other
established treatment options. We are grateful to the terlipressin study
investigators and medical institutions for their support and participation in
this study."
Types 1 and 2 HRS result in approximately 14,000 U.S. hospitalizations
annually, and there currently are no drugs approved for the treatment of HRS
in the United States. The U.S. FDA has granted terlipressin Fast Track
designation and Orphan Drug status for the treatment of type 1 HRS, as the
drug has demonstrated the potential to address an unmet medical need for a
serious or life-threatening condition. Orphan Therapeutics is responsible for
the development of terlipressin in this orphan indication. PDL holds the
exclusive marketing, sales and distribution rights to potentially
commercialize terlipressin in the United States and Canada.
About Hepatorenal Syndrome (HRS)
Patients with end-stage liver cirrhosis often develop portal hypertension,
or high blood pressure in the portal vein, the major vessel through which
blood normally is carried to the liver. Clinicians believe that, through a
complex interplay of mechanisms, blood unable to flow through the portal vein
is forced through alternate vessels that are not meant to carry such
significant blood flow. This, in turn, causes blood vessels to swell
(vasodilation), leading to a drastic reduction in blood flow to the kidneys,
resulting in life-threatening kidney or other organ failure.
HRS is an acute complication of liver cirrhosis. Replacing the diseased
liver to restore normal liver and kidney function is the only therapeutic
option that may aid in long-term survival. Results from the Phase 3 study
will determine if terlipressin may act as a bridge to transplant by restoring
kidney function until a liver transplant can be performed or help to alleviate
the acute crisis of the disease in patients ineligible to receive a
transplant.
About PDL BioPharma
PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering,
developing and commercializing innovative therapies for severe or
life-threatening illnesses. The company currently markets and sells a
portfolio of leading products in the acute-care hospital setting in the United
States and Canada and generates royalties through licensing agreements with
top-tier biotechnology and pharmaceutical companies based on its pioneering
antibody humanization technology. Currently, PDL BioPharma's diverse
late-stage product pipeline includes six investigational compounds in Phase 2
or Phase 3 clinical development for hepatorenal syndrome, autoimmune and
inflammatory diseases, cardiovascular disorders and cancer. Further
information on PDL BioPharma is available at http://www.pdl.com.
PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL
BioPharma, Inc.
SOURCE PDL BioPharma, Inc.
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Related links:
http://www.pdl.com
CONTACT:
Jean Suzuki, Product Communications,
+1-510-574-1550, jean.suzuki@pdl.com, or Jim Goff, Investor
Relations, +1-510-574-1421, james.goff@pdl.com, both of PDL
BioPharma, Inc.
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