Collaboration Developed to Support the RESTORE Clinical Trial Program
FREMONT, Calif. and HOFSTADE, Belgium, Oct. 23 /PRNewswire-FirstCall/
-- PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI), a California-based
biopharmaceutical company, and the European Crohn's and Colitis
Organization (ECCO) announced today that they are collaborating to increase
awareness among European physicians about a clinical research program for
visilizumab, an antibody treatment under investigation for intravenous
steroid refractory ulcerative colitis (IVSR-UC). The collaboration furthers
ECCO's mission to optimize care for patients with inflammatory bowel
disease, a serious condition that affects more than 1.5 million people in
Europe.
"Ulcerative colitis may be a devastating disease that affects people
who, in the most severe cases, are often faced with life-altering
treatments such as colon removal surgery as their only hope of symptom
relief," said Miquel Gassull, M.D., Ph.D., President of ECCO. "ECCO is
pleased to be part of advancing research into new treatment options that
could represent a much needed treatment alternative for these patients. For
ECCO, this is the first time we have collaborated with a sponsor such as
PDL to take an active role in helping to support an important clinical
research program."
"We are very pleased to have a relationship with ECCO to ensure the
optimal design and conduct of the studies in the RESTORE program, which are
evaluating visilizumab, a monoclonal antibody also known as Nuvion(R), as a
potential treatment for IVSR-UC. ECCO's deep knowledge of inflammatory
bowel disease and unique structure linking leaders in the field from a wide
variety of countries will be a key success factor for the program," said
Steven Benner, M.D., Chief Medical Officer of PDL BioPharma.
The collaboration between PDL and ECCO will ensure accurate and timely
communications about the RESTORE program and disease awareness of IVSR-UC
through ECCO's leading network of physicians in Europe. ECCO is committed
to leading specific initiatives among members of its network to ensure the
success of this relationship.
The RESTORE program includes clinical trials conducted worldwide to
evaluate visilizumab as a potential treatment for IVSR-UC. Visilizumab is
designed to target and block the action of T cells, the cells believed to
cause UC, with the aim of significantly reducing the symptoms of UC and
potentially delaying the need for colectomy, or surgical removal of the
colon.
The RESTORE trials are currently enrolling patients with IVSR-UC who no
longer respond to standard medical therapies in Europe, the U.S. and other
countries worldwide. The aim of the trials is to determine if visilizumab
can reduce patient symptoms and potentially delay the need for colon
removal surgery. Additional studies in the RESTORE program that are
assessing long- term safety and retreatment are ongoing.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease caused by an abnormality in the
body's immune system that leads to inflammation and ulceration of the
innermost lining of the colon (or large intestine), which can cause
diarrhea, pain and bleeding. In severe cases, individuals may have diarrhea
10 to 20 times a day, which may lead to dehydration, fever, hospitalization
and the need for blood transfusions. More than one million people worldwide
suffer from UC, which primarily affects men and women in their 30s, but can
occur at any age. An estimated 25 to 40 percent of these patients
eventually fail to respond to standard medical therapy of oral and
intravenous steroids.
About ECCO
The European Crohn's and Colitis Organization (ECCO) is a non-profit
scientific organization founded in 2001, currently with 24 member nations.
The goals of ECCO are to promote, sponsor and steer European international
research efforts in the field of inflammatory bowel disease (IBD) and to
develop protocols for studies which can be performed in European centers;
to organize education and exchange in the field of IBD; to develop
cooperation with patient organizations and other organizations sharing
interest in IBD; to establish consensus and challenge dogmas in the field
of IBD; to have a political voice in Europe and interact with the
pharmaceutical industry; to educate "nurse specialists" in IBD; to
participate in the activities of the United European Gastroenterology
Federation (UEGF); and to influence the future of IBD management in Europe
and beyond. For more information, please visit the ECCO website at
http://www.ecco-ibd.org.
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's
diverse product pipeline includes investigational compounds in Phase 2 or
Phase 3 clinical development for inflammation and autoimmune diseases,
cardiovascular disorders and cancer. The company's research platform is
focused on the discovery and development of antibodies for the treatment of
cancer and autoimmune diseases. For more information, please see PDL's
website at http://www.pdl.com.
NOTE: 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, Corporate and Investor Relations
of PDL BioPharma, Inc., +1-510-574-1550, or jean.suzuki@pdl.com;
or Dr. Daan Hommes, Chairman of the ECCO Scientific Committee,
d.w.hommes@lumc.nl
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